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

Catalog Number 82097-01

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a right internal carotid artery with heavy calcification, pre-dilatation was performed with a 4x20 mm viatrac balloon catheter.A 10tx30x136 xact carotid stent system was advanced but could not cross and the stent system was getting caught on the coalification.A 5x20 mm viatrac balloon catheter was advanced and additional dilatation was performed.The xact carotid stent system was re-advanced with a buddy guide wire but still could not cross the lesion and the stent system was getting caught on the calcification.Reportedly, slight resistance was felt during removal of the xact carotid stent system both times from the patient anatomy.A 7-10x30 mm acculink carotid stent system was advanced and successfully crossed and the stent was implanted to treat the target lesion.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.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 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: 4661701
• MDR Text Key: 5608275
• Report Number: 2024168-2015-01845
• 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: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 82097-01
• Device Lot Number: 4101061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 76 YR
• Patient Weight: 70