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

Catalog Number 1125250-15

Device Problems Kinked (1339); Difficult To Position (1467); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the diagonal artery.The 2.5x15mm xience alpine stent delivery system (sds) met resistance during advancement into the guiding catheter and the shaft kinked.The sds was removed without issue.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.A new 2.5x15mm xience alpine sds was used to successfully complete the procedure.There was no additional information provided.The sds was returned with the shaft guide wire exit notch torn.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported shaft kink was confirmed.Additionally, the shaft was noted to be torn.The reported difficulty to position in a guiding catheter was confirmed.Based on a visual, dimensional, and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4601164
• MDR Text Key: 17294415
• Report Number: 2024168-2015-01382
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2017
• Device Catalogue Number: 1125250-15
• Device Lot Number: 4111741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 58 YR