Please improve it by verifying the claims made and adding inline citations. This section possibly contains original research. With a population of 110,003 during the 2020 census, Temecula is the 5th most populous city in Riverside County. Temecula is bordered by the city of Murrieta to the north and the Pechanga Indian Reservation and San Diego County to the south. The city of Temecula, forming the southwestern anchor of the Inland Empire region, is approximately 58 miles (93 km) north of downtown San Diego and 85 miles (137 km) southeast of downtown Los Angeles. Although Temecula is geographically closer to downtown San Diego than downtown Los Angeles, it is considered part of the Greater Los Angeles area. The city is a tourist and resort destination, with the Temecula Valley Wine Country, Old Town Temecula, the Temecula Valley Balloon & Wine Festival, the Temecula Valley International Film Festival, championship golf courses, and resort accommodations for tourists which contribute to the city's economic profile.
It was reported through a research article identifying the absorb scaffold and xience drug eluting stent that may be related to a cardiac mortality, myocardial infarction, revascularization, and thrombosis.ĭetails are listed in the article, titled, three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: a meta-analysis by goel et al.Temecula ( / t ə ˈ m ɛ k j ʊ l ə/ Spanish: Temécula, Luiseño: Temeekunga) is a city in southwestern Riverside County, California, United States. The additional adverse patient effect of death referenced is being filed under a separate medwatch report #. The xience device referenced is being filed under a separate medwatch report #. There is no indication of a product quality issue with respect to manufacture, design or labeling. Post-dilatation is strongly recommended for optimal scaffold apposition.Ī conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. Pre-dilatation should be performed with an angioplasty balloon which can also be utilized to properly size the vessel. Pre-dilate the lesion to match the reference vessel diameter with a percutaneous transluminal coronary angioplasty catheter. It should be noted that the absorb gt1 bioresorbable vascular scaffold (bvs) system, electronic ifu, states: implantation of the device in vessels < 2.ĥ mm may lead to an increased risk of adverse events such as myocardial infarction and scaffold thrombosis. It was reported that the implantation technique (adequate pre-dilation with a non-compliant balloon, implantation after confirmation of adequate pre-dilations, and post-dilation with a non-compliant balloon), and inadequate sizing were factors in the increase risk for the reported patient effects. The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb gt1 bioresorbable vascular scaffold (bvs) system instructions for use as known adverse events that may be associated with treatment procedures and the use of coronary scaffold. The device was not returned for evaluation.Ī review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.
Udi #: udi is listed as unk because the part and lot numbers were not provided.Īrticle titled: three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: a meta-analysis.
#Electronic medical records training 92591 code
During processing of this complaint, attempts were made to obtain complete event, patient and device information.ĭevice code 2017 - failure to follow steps/instructions (poor implantation technique and inadequate sizing referenced in the article.