MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Catalog Number 82097-01

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo lesion located in the heavily tortuous, mildly calcified, 85% stenosed, distal common carotid artery.The 10tx30x136 xact stent delivery system (sds) reached the target lesion; however, the stent implant could not be released.Resistance was felt during advancement of the sds to the lesion and the shaft (outer member) separated during use.The device was changed for another sds and the procedure was completed successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The failure to deploy was not able to be confirmed as the stent was not returned.The reported separation of the shaft was confirmed.The resistance could not be confirmed as it was based on case circumstances.Based on a visual 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.A query of the electronic complaint handling database revealed no other incidents for failure to deploy, resistance or separation reported from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 3988897
• MDR Text Key: 4755599
• Report Number: 2024168-2014-05016
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040038
• 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
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 82097-01
• Device Lot Number: 1101961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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