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

Model Number	82086-01
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - excessive force.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, tortuous left carotid artery that is 80% stenosed.A 6fr short sheath was used for access and diagnostic images were obtained.The sheath was exchanged for a 6fr 90cm sheath.A emboshield nav6 embolic protection system was advanced with resistance felt with anatomy; however, deployed successfully.The lesion was pre-dilated with a 4x20mm viatrac balloon and a 9tx40x136 xact carotid stent system was attempted to be advanced; however could not advance due to anatomy.A 5.0x30mm viatrac balloon was used to dilate the lesion again with successful inflation and the xact was attempted to advance variety of ways including with an unspecified buddy wire and micro catheter; however, was unsuccessful due to anatomy.Then an unspecified acculink stent system along with an unspecified support catheter was attempted to be advanced; however, failed to cross due to anatomy.The xact was advanced one more time and was able to cross the lesion; however, resistance was met with calcium and became difficult to maneuver.During removal the stent was stuck in the sheath and to hold the sheath in the groin while the stent was forcibly pull out.The case was aborted.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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 resistance was met with the heavily calcified, tortuous and 80% stenosed anatomy resulting in the reported failure to advance.Manipulation of the compromised device in attempts to advance resulted in the noted wrinkled and bunched shaft material; thus resulting in the reported difficult to remove and ultimately resulted in the noted sheath-shaft bond area material separation.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 heavily calcified, tortuous left carotid artery that is 80% stenosed.A 6fr short sheath was used for access and diagnostic images were obtained.The sheath was exchanged for a 6fr 90cm sheath.A emboshield nav6 embolic protection system was advanced with resistance felt with anatomy; however, deployed successfully.The lesion was pre-dilated with a 4x20mm viatrac balloon and a 9tx40x136 xact carotid stent system was attempted to be advanced; however could not advance due to anatomy.A 5.0x30mm viatrac balloon was used to dilate the lesion again with successful inflation and the xact was attempted to advance variety of ways including with an unspecified buddy wire and micro catheter; however, was unsuccessful due to anatomy.Then an unspecified acculink stent system along with an unspecified support catheter was attempted to be advanced; however, failed to cross due to anatomy.The xact was advanced one more time and was able to cross the lesion; however, resistance was met with calcium and became difficult to maneuver.During removal the stent was stuck in the sheath and and to hold the sheath in the groin while the stent was forcibly pull out.The case was aborted.There was no adverse patient effects and no clinically significant delay.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: 23547461
• Report Number: 2024168-2025-11505
• Device Sequence Number: 15814643
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: (01)08717648010224(17)270531(10)4060761
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 12/08/2025

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: 82086-01
• Device Catalogue Number: 82086-01
• Device Lot Number: 4060761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: 6F 90CM SHEATH
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White