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	Stenosis (2263)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi number is not known as the part and lot number were not provided.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right internal carotid artery (ica) with 75% stenosis.On (b)(6) 2020, the patient was successfully implanted with a 8.0x40mm xact stent in the right ica.On (b)(6) 2021, a second procedure was performed as the previously implanted stent had become separated and it was noted the stent had 63% re-stenosis at the fractured site.A new stent was placed over the separated stent.There was no clinically significant delay.No additional information was provided.
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 complaints reported from this lot.The reported patient effect restenosis is listed in the xact instruction for use as a known adverse event potentially associated with carotid stents and embolic protection systems.Based on the information provided, a conclusive cause for the reported stent fracture and subsequent patient effects could not be determined.The unexpected medical intervention and hospitalization were related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11921202
• Report Number: 2024168-2021-04569
• Device Sequence Number: 3099202
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 12/31/2022
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 0011361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 73