MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number XRX04009T

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Event estimated dates.Visual analysis was performed on the returned device.The reported kink was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that kink likely occurred during use.It is likely that the shaft kink occurred during advancement in the anatomy.Follow up to the account confirmed that the hypotube jacket material that was pulled away from the guide wire exit port did not occur during use.It is likely that the damage occurred during packaging the product for return to abbott.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the delivery system of a xact carotid stent system was creased [kinked].The stent system was advanced into the patient anatomy; however, as soon as the crease was noted it was removed and not deployed.The procedure was successfully completed with a new xact carotid stent.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis identified that the tapered proximal end of the guide wire exit port was pulled away from the hypotube jacket material.No sections of the jacket material or proximal end of the guide wire exit port appear to be missing.Follow-up with the account stated that this damage did not occur during the procedure.No additional information was provided.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9707772
• MDR Text Key: 179317918
• Report Number: 2024168-2020-01474
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: XRX04009T
• Device Lot Number: 7121261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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