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

Catalog Number 1010133-30

Device Problems Defective Device (2588); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a 90% stenosed de novo lesion in the internal carotid artery with mild calcification and mild tortuosity.An embolic protection device (epd) was advanced to the it's intended location; then, the 7-10x30mm acculink self-expanding stent system (sess) was advanced to the target lesion.The position of the sess was confirmed and the hemostatic valve was opened.The physician began to deploy the stent; however, during deployment the stent shortened and jumped proximal to the target lesion and did not fully cover the lesion.The stent deployed partially in the lesion and partially in healthy tissue.Therefore, a 9-7x40mm xact stent was deployed to cover the lesion.Post-dilatation was performed followed by removal of the epd.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

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 incidents from this lot.It is possible that the delivery system was slightly pushed distally as the stent was being deployed and/or interaction with the mildly calcified, mild torturous and 90% stenosed anatomy resulting in the reported stent shortened; then eventually the stent jumped in a spring like release resulting in the reported stent malposition; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16440238
• MDR Text Key: 310241850
• Report Number: 2024168-2023-01909
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

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: 02/29/2024
• Device Catalogue Number: 1010133-30
• Device Lot Number: 2030161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Treatment: 9-7X40MM XACT STENT; EPS DEVICE; TUOHY BORST HEMOSTATIC VALVE
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG