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

Model Number 305 X 23

Device Problems Positioning Failure (1158); Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

A 3.5 x 23 xience alpine rx stent was unable to be deployed.Distal end of stent was flared out and not able to advance lesion in left coronary.Once physician felt that he was unable to advance/cross the lesion, he took the stent out.Once stent was out of the catheter he noticed the frayed distal end.

• Brand Name: XIENCE ALPINE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez road; temecula CA 92591
• MDR Report Key: 5832754
• MDR Text Key: 50721522
• Report Number: 5832754
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/03/2019
• Device Model Number: 305 X 23
• Device Catalogue Number: 1125350-23
• Device Lot Number: 5121541
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 86