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

Model Number	82091-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	05/13/2021
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 stroke and thrombosis are listed in the xact instructions for use as a known potential adverse effects associated with carotid stents and embolic protection systems.Based on the case information, 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.Na.
Event or Problem Description
It was reported that this was a procedure to treat a lesion in the heavily calcified, mildly tortuous internal carotid artery.An emboshield nav 6 embolic protection system was advanced and deployed.A 4x20 mm viatrac dilatation catheter was used for pre-dilatation.A xact 8tx30x136 carotid stent system was advanced and deployed without any issue in the internal carotid artery.A 5x20 mm viatrac dilatation catheter was used for post dilatation and the emboshield nav 6 was retrieved without issue.Approximately, twenty-five minutes after the procedure, when the patient was in intensive care unit (icu); the patient experienced left side facial drooping and left side leg weakness.The patient had a stroke, no flow was observed in the internal carotid artery where the xact stent was implanted.The patient was transferred to a neighboring hospital that treats acute stroke patients.Tissue plasminogen activator and acute stroke intervention was performed, a clot was removed from xact stent with a non-abbott catheter and additional ballooning was performed with 6.0 x 20 viatrac balloon.The patient was kept overnight in the icu.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: 11936351
• Report Number: 2024168-2021-04660
• Device Sequence Number: 19877788
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: 08717648010279
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 82091-01
• Device Catalogue Number: 82091-01
• Device Lot Number: 0031861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/03/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 63