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

Catalog Number 1009529-18

Device Problems Break (1069); Kinked (1339); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that prior to use, during unpacking of the xience v 3.0 x 18 mm device, the shaft was found to be kinked.The device was not used on the patient.The procedure was completed with another xience v stent.There was no reported clinically significant delay in the procedure.Returned device analysis noted that the proximal shaft was torn and broken.Although it was initially reported that the shaft was noted to be kinked, additional information received clarified that the torn and broken proximal shaft was the damage noted during unpacking of the device.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The kink, tear, and break were confirmed.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 incidents for kinks, breaks or for torn material on the shaft reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: XIENCE V 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: 3759633
• MDR Text Key: 4469635
• Report Number: 2024168-2014-02461
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2015
• Device Catalogue Number: 1009529-18
• Device Lot Number: 3100441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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