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

Catalog Number 1011344-40

Device Problem Activation Failure (3270)

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

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the internal carotid artery with mild calcification and mild tortuosity.An emboshield nav6 embolic protection system (eps) was deployed at the target location.The 7-10x40mm acculink self expanding stent (ses) was advanced to the lesion through a 6f 80cm non-abbott sheath over an unspecified 0.014 guide wire.The stent delivery system handle was pulled all the way, with no resistance noted; however, the acculink stent was only partially deployed at the target site.The non-abbott sheath was raised as much as possible and the acculink delivery catheter was removed, with half of the stent remaining in the guiding catheter.Using the eps retrieval catheter, the stent was pushed from the guiding catheter and was able to be completely deployed partially inside the target lesion and partially in healthy tissue.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is likely that interaction with the mildly calcified and mildly tortuous anatomy and/or inadvertent mishandling resulting in the noted device damages (wrinkled sheath, multiple shaft bends) resulted in preventing the shaft lumens from moving freely thus resulting in the reported activation failure.As reported, the non-abbott sheath was raised as much as possible and the acculink delivery catheter was removed, with half of the stent remaining in the guiding catheter.Using the embolic protection system (eps) retrieval catheter, the stent was pushed from the guiding catheter and was able to be completely deployed partially inside the target lesion and partially in healthy tissue.Based on the reported information and results of the complaint investigation 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
• 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: 18767783
• MDR Text Key: 336115211
• Report Number: 2024168-2024-02316
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)241130(10)2121361
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011344-40
• Device Lot Number: 2121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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: 0.014 GUIDE WIRE; 6F 80CM SHEATH; EMBOSHIELD NAV6
• Patient Outcome(s): Required Intervention