MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	82086-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a xact stent was implanted in the mildly calcified, mildly tortuous, 90% stenosed internal carotid artery.During a follow up on (b)(6) 2024, it was noted that the stent had separated into two pieces.Reportedly, the patient was not stimulated by external forces and was able to move normally.The physician plans to perform surgery to remove the stent and the patient has been transferred to an external hospital for treatment.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.In summary it was reported that a xact stent was implanted in a 90% occluded carotid artery with mild calcification and mild tortuosity.Approximately 4 months later during follow-up, the stent was found to be separated.No probable cause could be determined but it is noted that the stent fracture is at a bend point for the patient¿s neck.It is possible that fatigue from cardiac dynamics and motion in the months after the procedure resulted in the reported stent separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: XACT CAROTID STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18888362
• Report Number: 2024168-2024-03219
• Device Sequence Number: 7605560
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/12/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 82086-01
• Device Lot Number: 2110861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown