MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Model Number	1011343-40
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that the shaft separation occurred with the resistance from the anatomy and interaction with the associated devices, ultimately all components were removed as the embolic protection system retrieval catheter pulled the broken portion into guiding catheter with additional resistance; however, a conclusive cause cannot be confirmed without the return of the device for examination.The occlusion and unexpected recovery of the separated portion is based on procedural circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.
Event or Problem Description
It was reported that the procedure was to treat the internal carotid artery.Prior to implantation of the 6-8x40 mm acculink stent, the self-expanding stent system (sess) was checked to confirm that the stent was intact.The acculink sess was advanced to the lesion without resistance and the stent was deployed.During removal of the delivery system, it was found that the shaft of the delivery system had separated.The separated portion was blocking blood flow and there was the potential to cause a cerebral infarction.The embolic protection system retrieval catheter was immediately advanced to the embolic protection device and the filter and the broken portion of the stent delivery system were able to be pulled into the guiding catheter and removed.There was some resistance noted with the guide catheter during removal.No abnormalities were seen on angiography once everything was removed.The patient showed no abnormal symptoms when checked on the following two days.No additional information was provided.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12170714
• Report Number: 2024168-2021-06072
• Device Sequence Number: 3782325
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 07/31/2022
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 0082661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/14/2021
• 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: Required Intervention