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

Catalog Number UNK RX XPEDITION

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombosis (2100); Heart Failure (2206); Stenosis (2263)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: estimated dates.The stent remains in patient.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.A conclusive cause for the reported patient effects of myocardial infarction, stenosis, cerebrovascular accident, heart failure and thrombosis, and the relationship to the product, if any, cannot be determined.The reported patient effects of myocardial infarction, thrombosis, stenosis, cerebrovascular accident and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling the other two xience devices referenced are being filed under separate medwatch report numbers.The additional patient effect of patient death referenced is being filed under a separate medwatch report.

Event Description

It was reported through a research article identifying xience v, xience prime, xience xpedition and non-abbott stents that may be related to death and serious injuries.Details are listed in the attached article, titled long-term clinical outcomes after percutaneous coronary intervention to treat long lesions in hemodialysis patients in the era of second-generation drug-eluting stents.

Manufacturer Narrative

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

• Brand Name: XIENCE XPEDITION 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: 9825661
• MDR Text Key: 185909516
• Report Number: 2024168-2020-02359
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XPEDITION
• 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