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

Catalog Number 1017250-15

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2013

Event Type  malfunction  

Event Description

It was reported that during preparation of the 2.5 x 15 mm xience pro stent delivery system (sds), the physician noticed that there was a slight kink directly behind the blue tip of the tip; therefore,the device was not used.A new 2.5 x 15 mm xience pro stent was then used successfully.A 3.0 x 8 mm xience pro sds was then advanced, but could not be placed.It is unknown what additional steps were taken.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis of the 2.5 x 15 mm xience pro sds found that the soft tip is torn.

Manufacturer Narrative

(b)(4).The xience pro is currently not commercially available in the us.The product code listed and the pma# listed are d on the predicate device (xience v) and is therefore similar to a device sold in the us.Evaluation summary: the device was returned for analysis.The kink on the tip was not confirmed.There was a tear in the soft tip at the very distal end of the tip.Based on a visual inspection analysis 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.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE PRO EVEROLIMUS ELUTING RX 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: 3691468
• MDR Text Key: 4291633
• Report Number: 2024168-2014-01688
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2015
• Device Catalogue Number: 1017250-15
• Device Lot Number: 3091241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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