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

Model Number 1011343-40

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/03/2021

Event Type  Injury  

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 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
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12170714
• MDR Text Key: 261717837
• Report Number: 2024168-2021-06072
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention