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

Catalog Number 1017350-15

Device Problems Material Deformation (2976); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that during unpacking and before use of the xience pro device, as device was pulled out of the plastic hoop, it was noticed that one strut of the device at the very distal segment was bent.The device was not used in the anatomy, therefore there was no patient involvement.Another 3.5 x 15 mm xience pro device was used for successful treatment of the target lesion.The final outcome was good.There was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis noted a torn soft tip.

Manufacturer Narrative

(b)(4).The xience pro is currently not commercially available in the us.Evaluation summary: the device was returned for analysis.The reported material deformation/ flared stent was able to be confirmed.Additionally, the soft tip was torn at the distal end.Based on a visual 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.A query of the electronic complaint 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: 3816614
• MDR Text Key: 4404750
• Report Number: 2024168-2014-03149
• 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: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2016
• Device Catalogue Number: 1017350-15
• Device Lot Number: 4021041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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