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

Model Number	82098-01
Medical Device Problem Codes	Component Missing (2306); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a 95% stenosed lesion in the right common carotid artery.A 10x30mm xact self-expanding stent system (sess) was prepared per the instructions for use.Following pre-dilatation, the sess was advanced and the deployment actuator was advanced without issues to deploy the stent; however, no stent came out.The sess was removed without issues and an attempt to deploy the stent outside the patient anatomy was made, but again no stent came out.It was reported that it seemed as though the stent was missing.The procedure was successfully completed with a 10x8mm unspecified tapered stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The return device analysis identified that the stent implant was partially exposed from the distal sheath and not expanded.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The distal end of the stent implant was located approximately 0.7mm from the distal end of the sheath; therefore, the reported missing stent was not confirmed.However, the deployment mechanism did not function properly.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 investigation determined that the deployment failure appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: XACT CAROTID
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9446193
• Report Number: 2024168-2019-14349
• Device Sequence Number: 480445
• Product Code: NIM
• UDI-Device Identifier: 08717648010347
• UDI-Public: 08717648010347
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 06/30/2021
• Device Model Number: 82098-01
• Device Catalogue Number: 82098-01
• Device Lot Number: 8072461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6FRX80CM COOK
• Patient Age: 66 YR
• Patient Weight: 86