MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XACT¿; STENT, CAROTID

Model Number	82088-01
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during positioning of the device, the barewire was inadvertently pulled causing the filter to migrate; thus resulting in the reported activation failure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the internal carotid artery.A 190cm emboshield nav 6 embolic protection system (eps) was successfully deployed in the distal portion of the lesion.At this point a 9sx30mm on 136cm xact carotid self-expanding stent (ses) was prepared and advanced to the lesion with no noted issues; however during deployment the access system [delivery catheter] was noted to not be stable, and before the stent was apposed to the vessel wall, it was found that the protective filter, stent and 6fr sheath tube fell down [migrated] to the aortic branch.Therefore, the surgeon removed the ses, filtration element and the sheath from the anatomy, and re-stabilized the vessel access by redeploying the same eps device and re-advancing the introducer sheath.The xact ses was replaced with a 8×40mm xpert pro stent to complete the procedure.There was no clinically significant delay nor adverse patient effects reported.No additional information was provided.

• Brand Name: XACT¿
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 22907147
• Report Number: 2024168-2025-09148
• Device Sequence Number: 12766998
• Product Code: NIM
• UDI-Device Identifier: 08717648010248
• UDI-Public: (01)08717648010248(17)270930(10)4102861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82088-01
• Device Catalogue Number: 82088-01
• Device Lot Number: 4102861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F NEUROMAX.
• Patient Sex: Unknown