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

Catalog Number UNK XIENCE

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

Patient Problems Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Age of patient: average.Gender of patient: majority.The udi is unknown because the part number and lot number were not provided.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.It should be noted that the reported patient effects of myocardial infarction, ischemia, and thrombosis are listed in the xience v everolimus eluting coronary stent systems instructions for use, as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The patient death referenced is being filed under a separate medwatch report.Literature: bioresorbable polymer-coated thin strut sirolimus-eluting stent vs durable polymer-coated everolimus-eluting stent in daily clinical practice: propensity matched one-year results from interventional cardiology network registry.

Event Description

It was reported through a research article that the xience stent may be related to death, st elevation, myocardial infarction, stent thrombosis (acute, subacute, and late), ischemia, requiring hospitalization, surgical bypass, and target vessel revascularization.Specific patient information is documented as unknown.Details provided in the attached article titled: " bioresorbable polymer-coated thin strut sirolimus-eluting stent vs durable polymer-coated everolimus-eluting stent in daily clinical practice: propensity matched one-year results from interventional cardiology network registry.¿.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• 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
• MDR Report Key: 10146328
• MDR Text Key: 194962142
• Report Number: 2024168-2020-04953
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR