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

Model Number	82091-01
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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 interaction with the mildly calcified anatomy prevented the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.Manipulation of the compromised device in attempts to deploy the stent ultimately resulted in the reported/noted sheath-shaft bond area material separation (device felt looser than usual when attempting to deploy).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.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified internal carotid artery.The 8x30x136 xact stent was advanced to the target lesion and when attempting to deploy the stent completely failed to deployed.There was no resistance felt; however, it was noted that the device felt looser than usual when attempting to deploy.Therefore, another unspecified stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.Per device analysis a separation was noted at the sheath-shaft bond area.There was no additional information 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: 23661071
• Report Number: 2024168-2025-11775
• Device Sequence Number: 15734193
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: (01)08717648010279(17)260430(10)3050361
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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 Expiration Date: 04/30/2026
• Device Model Number: 82091-01
• Device Catalogue Number: 82091-01
• Device Lot Number: 3050361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG