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

Catalog Number 1010131-40

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a chronic total occlusion in a heavily calcified, moderately tortuous de novo carotid artery.It took many attempts to cross the lesion with the 10x40mm acculink self-expanding stent system.The lesion was pre-dilated to crack the calcium.After implanting the stent, it was observed that stent looked like an hourglass and it was fixed with post-dilatation.Additionally, the tip and distal end of the shaft were separated.It was attempted to retrieve the separated portion with a microcatheter and snare device but was unsuccessful.The separated tip and shaft became stuck in calcified plaque between the vessel and the acculink stent.The physician decided to cover the tip and shaft using a graftmaster stent to prevent further damage to the patient.A clinically significant delay was reported.The patient was transferred to the stroke department for further observation.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported resistance during advancement and stent wall apposition was unable to be confirmed as it was based on procedural circumstances.The shaft separation 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.Based on the reported information and evaluation of the returned unit, the reported difficulty advancing was likely due to the anatomical challenges as the anatomy was described as a chronic total occlusion in a heavily calcified, moderately tortuous de novo carotid artery.In addition, the hypotube separation likely occurred during the many attempts to cross the lesion while advancing against resistance.It is likely that the separation initiated from a kink which ultimately separated.The reported mal-apposed stent was likely the result of the lesion calcification and narrowed vessel preventing full expansion of the stent.The unexpected medical intervention to embed the separated portion of the shaft resulting in delay in treatment was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12271362
• MDR Text Key: 264957144
• Report Number: 2024168-2021-06790
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 1010131-40
• Device Lot Number: 0061761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR