MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1125225-12

Device Problems Difficult To Position (1467); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The stent damage was able to be confirmed.Additionally, the guide wire exit notch was torn and lifted from the shaft for a length of 2mm.The difficult to position could not be replicated in a testing environment due to the condition of the returned device.Based on a visual and dimensional inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the diagonal artery.While trying to advance the 2.25 x 12 mm xience alpine stent delivery system (sds) inside the non-abbott guide extension the sds met resistance inside the guide and did not exit the tip of the guide.After retraction of the sds from the guide it was observed that the stent struts were flared.Another same sized sds was used for the procedure without further issue.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Analysis of the device revealed a torn guide wire exit notch.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5474360
• MDR Text Key: 39522800
• Report Number: 2024168-2016-01270
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 1125225-12
• Device Lot Number: 5082141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1