Catalog Number UNK RX PRIME |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Myocardial Infarction (1969); Perforation (2001); Thrombosis (2100)
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Event Date 10/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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The date of event was estimated.The date of implant was estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of perforation, intimal dissection, thrombosis and myocardial infarction are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported perforation, intimal dissection, thrombosis and myocardial infarction, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature article title: "additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: results of the press trial".The udi number is unknown as the part and lot #s were not provided.The patient death(s) referenced are being reported on a separate medwatch report #.
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Event Description
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It was reported through a research article identifying xience prime that may be related to the following: death, dissection, perforation, myocardial infarction, stent thrombosis, and target vessel revascularization.Specific patient information is documented as unknown.Details are listed in the article, titled, "additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: results of the press trial.".
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Search Alerts/Recalls
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