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

Catalog Number 1010132-30

Device Problems Break (1069); Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an acculink self-expanding stent was successfully deployed in the internal carotid artery; however, it was hard to move the pullback handle during deployment.By readvancing the pullback handle the whole handle broke into parts.It was possible to remove the stent delivery system from the patient without any problems.There was a reported delay in the procedure; however, there were no reported adverse patient effects.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment issue and failure to retract the slider was unable to be confirmed due to the condition of the returned unit.The gap in the handle was confirmed.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 deployment issue.It may be possible that the distal shaft was entrapped within the vessel such that the slider was difficult to retract during deployment; however, this could not be confirmed.Applying force while retracting the slider likely caused the slider cover on the handle to partially separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6- reported device code 1562 was removed.

Event Description

Additional information was received stating that "by readvancing the pullback handle the whole handle broke into parts" was referring to a gap between the distal portion of the handle halves.The procedure was completed with the successfully deployed acculink ses.There was no significant impact to the patient due to a reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX ACCULINK
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9949738
• MDR Text Key: 187705394
• Report Number: 2024168-2020-03571
• Device Sequence Number: 1
• Product Code: NIM
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 1010132-30
• Device Lot Number: 8101561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1