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

Catalog Number 1010133-40

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported deployment issue was confirmed.It was noted that the stent was exposed and the proximal end of the sheath was kinked.During device analysis, the handle was opened and it was noted that the handle slider was restricted at the location of observed bunching within the handle.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.The investigation was unable to determine a cause for the reported deployment issue.It may be possible that the distal shaft was bent or entrapped within the vessel such that the slider was unable to retract.The kink noted on the returned unit at the proximal end of the sheath further suggests that the distal shaft was likely kinked in the anatomy; however, this could not be confirmed.Applying force during the attempt to retract the slider against resistance likely caused the outer member to stretch and bunch as the slider was moved distally further obstructing movement as was observed on the returned device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Device analysis revealed the stent implant was exposed 1.7mm from the distal end of the sheath.It was reported that the procedure was to treat a moderately calcified lesion in the heavily tortuous right common carotid artery.The acculink stent system was advanced to the lesion and during deployment, the handle was unlocked, but resistance was noted when pulling back the handle and the stent failed to deploy.The device was easily removed.There was no adverse patient effect or a clinically significant delay in procedure.An acculink 6-8x40mm was deployed successfully to complete the procedure.Although it was reported that the device completely failed to deploy, a slight deployment occurred as the stent was noted to be exposed from the distal end of the sheath, per the returned device analysis.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: 12046676
• MDR Text Key: 261489162
• Report Number: 2024168-2021-05305
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 1010133-40
• Device Lot Number: 0090261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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