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

Model Number	82096-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Stroke/CVA (1770); Ischemia (1942); Thrombosis/Thrombus (4440)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 complaints reported from this lot.The reported patient effects of ischemia, thrombosis and stroke are listed in the xact instruction for use (ifu) as known adverse events potentially associated with carotid stents and embolic protection systems.Based on the information provided, a conclusive cause for the reported stent fracture and subsequent patient effects could not be determined.The unexpected medical intervention and hospitalization were related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The acculink stent referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2021, a 10tx40x136 xact carotid stent was implanted to treat an occlusion in the heavily calcified, mildly tortuous, 90% stenosed left vertebral artery.On (b)(6) 2021, the patient presented for a second planned procedure in another vessel; however, it was noted that the xact stent implanted in may was broken circumferentially and severely blocking the blood flow.A 7-10/40 acculink stent was implanted as treatment, relieving the patient symptoms.Post procedure, the patient experienced a cerebral infarction from thrombus and was hospitalized for observation.No additional information was provided.

• Brand Name: XACT CAROTID STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12305091
• Report Number: 2024168-2021-07065
• Device Sequence Number: 3970478
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: 08717648010323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 82096-01
• Device Catalogue Number: 82096-01
• Device Lot Number: 0121561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability