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

Catalog Number	82096-01
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous internal carotid artery that is 70% stenosed.The 10tx40x136 implanted xact stent was noted to be entangled with an unspecified guide wire, making it impossible to recover the embolic protection system (eps).A catheter was used to assist to removed the eps/ guide wire.The xact stent remained successfully implanted.There was no adverse patient effects reported and no clinically significant delay in the procedure.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after successful implantation of the xact stent and removal of the xact catheter interaction with the unspecified guide wire inadvertently resulted in the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17966686
• Report Number: 2024168-2023-11571
• Device Sequence Number: 7623264
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: 08717648010323
• 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): 10/19/2023

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: 06/30/2025
• Device Catalogue Number: 82096-01
• Device Lot Number: 2073061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPIDERFX
• Patient Sex: Unknown