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

Model Number	82087-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Weakness (2145)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional 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.The reported patient effects of transient ischemic attack (tia) and weakness are listed in the xact instructions for use as known potential adverse effects associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional hospitalization was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the xact stent was successfully implanted in the internal carotid artery and the filter was successfully used and removed.There was a lesion distal to the stent that the physician decided not to treat as it was more narrow and the flow was fine.Later, while the patient was eating lunch, they began to experience symptoms of a trans-ischemic attack (tia) with weakness on the right side.A ct scan was performed but no other treatment was performed and the symptoms were improving.The patient was moved to the intensive care unit.The symptoms totally resolved within 24 hours.The physician noted that it was likely not due to the stent.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: 10466620
• Report Number: 2024168-2020-07210
• Device Sequence Number: 19605920
• Product Code: NIM
• UDI-Device Identifier: 08717648010231
• UDI-Public: 08717648010231
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 82087-01
• Device Catalogue Number: 82087-01
• Device Lot Number: 9081261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/28/2020
• 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
• Patient Age: 67 YR
• Patient Weight: 134