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

Model Number	82090-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints.Based on the information provided, a conclusive cause for the reported stent fracture/separation could not be determined.Fatigue from artery dynamics and motion may have contributed to the stent fracture; however, this could not be confirmed.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 patient presented with severe stenosis in the right internal carotid artery.A 8x40mm xact self-expanding stent was implanted on (b)(6) 2019.On (b)(6)2021, the patient was admitted into the hospital, and it was discovered that the implanted stent had separated.The patient was asymptomatic, and there was no treatment performed.The reason the patient was readmitted into the hospital was not related to an issue with the abbott stent.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

• 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
• MDR Report Key: 11902307
• Report Number: 2024168-2021-04501
• Device Sequence Number: 17029839
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 01/31/2022
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 9020461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1