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

Model Number	83031-01
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam was unable to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed).Production record and corrective and preventative 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 similar 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 and/or inadvertent mishandling prevented the shaft lumens from moving freely; thus contributing to the reported mechanical jam and activation/deployment failure.The noted separation at the shaft/sheath bond area likely occurred due to handling or during packing for return analysis.As reported by the account, the device was removed, and then on the table was able to deploy the stent.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 performed was to treat a mildly calcified internal carotid artery.Upon deployment of the 9x40mm xact carotid self-expanding stent, a problem occurred with the deployment mechanism [thumbwheel], and the stent completely failed to deploy.The device was tested on the table and the stent was deployed.An unspecified device was used to complete the procedure.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Returned device analysis observed there was a separation noted at the shaft/sheath bond area.The knob turned, and the stent sheath retracted with no resistance noted.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: 25188271
• Report Number: 2024168-2026-02012
• Device Sequence Number: 13345515
• Product Code: NIM
• UDI-Device Identifier: 08717648356674
• UDI-Public: (01)08717648356674(17)270731(10)408146Q
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/15/2026

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: 83031-01
• Device Catalogue Number: 83031-01
• Device Lot Number: 408146Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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
• Patient Sex: Unknown