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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that the tip separation occurred with the resistance from the anatomy and interaction with the associated devices (retrieval catheter) thus, limited clearance for the guiding catheter and ultimately all components were removed; however, a conclusive cause cannot be confirmed without the return of the device for examination.There is no indication of a product quality issue with respect to manufacture, design or labeling.The emboshield nav6 device referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat the left internal carotid artery with moderate calcification and moderate tortuosity.The 6-8x40 mm acculink self expanding stent system (sess) was advanced, the stent was implanted with no issues noted and the stent delivery system was removed with some resistance noted with the guide catheter.In process of retrieving the filter of the emboshield nav6 embolic protection system (eps), it was noted that the tip of the stent delivery system had broken off and was able to be visualized.The retrieval catheter was stuck, likely on the separated tip, and the guiding catheter was advanced over the retrieval catheter, allowing the filter and the separated tip of the delivery system to be withdrawn together as a system.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Nana.

Event Description

It was reported, that the procedure was to treat the left internal carotid artery with moderate calcification and moderate tortuosity.The 6-8x40 mm acculink self expanding stent system (sess) was advanced, the stent was implanted with no issues noted.And the stent delivery system was removed with some resistance noted, with the guide catheter.In process of retrieving the filter of the emboshield nav6 embolic protection system (eps), it was noted, that the tip of the stent delivery system had broken off and was able to be visualized.The retrieval catheter was stuck, likely on the separated tip.And the guiding catheter was advanced over the retrieval catheter, allowing the filter and the separated tip of the delivery system to be withdrawn together as a system.There were no reported adverse patient effects.And there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the emboshield nav6 and acculink sess were advanced without issue.The acculink delivery system was not checked immediately, once it came out of the patient.The retrieval catheter of the emboshield nav6 was advanced without resistance, but radiography showed, the retrieval catheter could not go through an area of foreign matter.Therefore, the retrieval catheter was withdrawn without resistance.The guiding catheter already present in the anatomy was advanced to retrieve the foreign matter and the emboshield nav6.The foreign matter was determined, to be the tip of the acculink delivery system.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
• MDR Report Key: 12085655
• MDR Text Key: 258987453
• Report Number: 2024168-2021-05533
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (y/n): N
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 0120161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6; EMBOSHIELD NAV6