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

Model Number	82096-01
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was treat an internal carotid artery that was not tortuous nor calcified.A 10tx40mm xact stent was advanced to the lesion through noted resistance passing over a.014 unspecified guide wire.During deployment of the stent the markers separated.The stent remained implanted and two additional unspecified stents were implanted to push the markers into the vessel wall.There was no adverse patient sequela and no clinically significant delay in the procedure.
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.It is possible that a build-up of procedural contaminants (blood, contrast) on the guide wire contributed to the reported difficult to advance; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult to advance cannot be determined.Additionally, it is possible interaction with the anatomy and/or other devices resulted in the reported stent markers separations; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported material separation cannot be determined.As reported, two additional unspecified stents were implanted to push the markers into the vessel wall.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.

• 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: 21091713
• Report Number: 2024168-2025-00242
• Device Sequence Number: 15647294
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: (01)08717648010323(17)270731(10)4082761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Model Number: 82096-01
• Device Catalogue Number: 82096-01
• Device Lot Number: 4082761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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: GUIDEWIRE: .014 UNKNOWN BRAND.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown