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

Catalog Number 82091-01

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure above the bifurcation of the internal carotid artery, an endarterectomy cutdown was performed; the barewire guide wire was positioned and the xact self-expanding stent system (sess) was advanced through the sheath but met unspecified resistance and could not be positioned in the vessel to cover the marginal bridge area.It was decided to remove the guide wire, however, it caught in the sess and the devices became entangled and neither could be advanced or removed separately.It was noted that excessive tugging was attempted to separate the devices without success and the guide wire became shredded while inside the sess.The devices were removed as a system from the anatomy without issue and the procedure was completed using a second abbott stent.The patient was noted as stable throughout the procedure.Post-procedure the patient was able to wiggle his toes and was responsive to commands.There was no reported adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported entanglement with the barewire, difficulty removing, and damage caused by the barewire was confirmed.Based on a visual dimensional and functional analysis of the returned product, 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.The barewire guide wire referenced is being filed under a separate manufacturing report number.

• 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: 4779742
• MDR Text Key: 22151067
• Report Number: 2024168-2015-02822
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• 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: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 82091-01
• Device Lot Number: 4111761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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
• Treatment: BAREWIRE WORKHORSE FILTER DELIVERY WIRE 315CM
• Patient Age: 50 YR
• Patient Weight: 84