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 Code	Stroke/CVA (1770)
Date of Event	11/24/2020
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 effect of stroke is listed in the xact instructions for use as a known potential adverse effect associated with carotid stents and embolic protection systems.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment with medications 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 procedure was to treat a carotid artery.A xact stent was implanted without issues and worked as intended.The patient was fine and sent to the post operation room.However, two hours later, the patient became unresponsive and started showing unspecified stroke symptoms.A computed tomography scan was performed and did not reveal any bleed.Therefore, tissue plasminogen activator (tpa) medication was provided and the patient condition improved.Per the physician, the xact stent did not cause or contribute to the stroke symptoms but rather the patients clinical condition of contralateral occlusion did.There was no adverse patient sequela and no clinically significant delay.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: 10979919
• Report Number: 2024168-2020-10350
• Device Sequence Number: 3034119
• 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): 12/09/2020

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: 07/31/2023
• Device Model Number: 82087-01
• Device Catalogue Number: 82087-01
• Device Lot Number: 0082062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86