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

Catalog Number 82090-01

Device Problem Material Separation (1562)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 03/09/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 from this lot.The reported patient effects of thrombosis and stenosis are listed in the xact carotid stent system instructions for use as possible adverse events associated with the use of this device.It is possible that over time fatigue due to the stent being implanted on a bend resulted in the reported stent separation; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, it is possible the reported difficulties caused/contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2023, a xact self expanding stent was implanted on a bend to treat the left internal carotid artery with heavy calcification, mild tortuosity and 90% stenosis.One year later at follow up on (b)(6) 2024, the stent was noted to be separated and there was thrombosis inside the stent confirmed by angiography, and severe stenosis occurred.No treatment was performed.No additional information was provided.

• Brand Name: XACT CAROTID STENT SYSTEM
• 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: 18987897
• MDR Text Key: 338726557
• Report Number: 2024168-2024-03761
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: (01)08717648010262(17)251031(10)2111661
• 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: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82090-01
• Device Lot Number: 2111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2022
• 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 Outcome(s): Hospitalization