MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 05/01/2009

Event Type  Death  

Manufacturer Narrative

Date of event, death, implant: dates 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 numbers were not provided.The reported patient effect of death is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported death, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional adverse patient effects referenced will be filed under a separate medwatch report #.The udi is unknown as the part and lot numbers were not provided.Attachment - article title: shorter (=6 months) vs.Longer (=12 months) dual antiplatelet therapy after second-generation drug-eluting stents implantation: a meta-analysis of randomized controlled trials.

Event Description

It was reported through a research article identifying xience v that may be related to the following: patient death, thrombosis, myocardial infarction, stroke, bleeding, revascularization, and rehospitalization.This article summarizes clinical outcomes of 1,812 patients that were treated with xience v stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "shorter (=6 months) vs.Longer (=12 months) dual antiplatelet therapy after second-generation drug-eluting stents implantation: a meta-analysis of randomized controlled trials.".

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11422988
• MDR Text Key: 234978120
• Report Number: 2024168-2021-01742
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death