MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE; CORONARY DRUG-ELUDING STENT

Catalog Number 1125350-23

Device Problems Bent (1059); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

Stent strut was observed to be bent upon removing from packaging.New product was obtained and used for procedure.

• Brand Name: XIENCE
• Type of Device: CORONARY DRUG-ELUDING STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054 280
• MDR Report Key: 4459235
• MDR Text Key: 5184335
• Report Number: 4459235
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 1125350-23
• Device Lot Number: 4060341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 116