MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Catalog Number	1011343-30
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2019001.The device was received.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 to treat a heavily tortuous left common carotid artery.The patient presented with an aneurysm.The physician accessed the right groin with a 6 x 9 non-abbott sheath.A 6-8/30 acculink stent device was advanced and the shaft made a 90 degree turn (large bend) at the aneurysm.A bend at the shaft was noticed.There was a bit of a resistance due to the anatomy, but the device was able to cross the target lesion.Initially, the physician could not get the stent to deploy.But then the stent ultimately did deploy.However, during removal, the device became separated at the shaft.Although a separation occurred, the separated portion remained on the micro wire and everything was simply pulled out.Nothing remained in the patient.The patient is stable.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation and damage to the shaft were confirmed.The failure to advance and deployment issue were not able to be confirmed due to the condition of the returned device.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 complaints.The investigation determined that the reported difficulties were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACCULINK
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9212556
• Report Number: 2024168-2019-12759
• Device Sequence Number: 16219678
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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 Catalogue Number: 1011343-30
• Device Lot Number: 9031161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/20/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: 6X9 SHUTTLE SHEATH
• Patient Age: 73 YR
• Patient Weight: 59