MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Model Number	1011343-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.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 lesion in the right internal carotid artery.A 6-8x30mm acculink self-expanding stent system (sess) was advanced to the lesion successfully.During deployment, the stent became exposed for 1-2mm and would not deploy any further.The sess was removed successfully, and a new same size accullink stent was used to successfully complete the procedure.There were no issues with the deployment mechanism.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported deployment issue was confirmed.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.The investigation determined that the deployment issue was related to operational context.It is likely that the bends and smashed portions noted throughout the shaft prevented movement of the shaft lumens and contributed to the deployment issue.The bends likely occurred during advancement through the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: returned goods lab identified a sheath separation on the device, but this was not noted during during the procedure.There was no resistance noted during the procedure, and it was confirmed that nothing remains in the patient anatomy.No additional information was provided.

• Brand Name: ACCULINK
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9520024
• Report Number: 2024168-2019-14973
• Device Sequence Number: 535492
• Product Code: NIM
• UDI-Device Identifier: 08717648076367
• UDI-Public: 08717648076367
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• 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): 03/02/2020

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: 02/28/2021
• Device Model Number: 1011343-30
• Device Catalogue Number: 1011343-30
• Device Lot Number: 9032861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2019
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 73