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

Catalog Number	1011344-40
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a 70% stenosed lesion in the left internal and external carotid artery.The lesion was pre-dilated with a 5.0x30mm viatrac balloon catheter.A 7.0x10mm acculink self expanding stent system (ses) was advanced to the target lesion however when pulling handle the stent did not deploy.The handle was retracted a little bit and pulled back again however the stent still did not deploy.The ses was removed and replaced with another acculink of the same size.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Return device analysis noted the outer member was separated from the slider.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was able to be confirmed.Electronic lot history record (elhr) and corrective and preventive actions (capa) 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 70% stenosed anatomy and/or inadvertent mishandling resulted in the noted wrinkled sheath resulting in preventing the shaft lumens from moving freely; thus resulting in the reported activation failure.Manipulation of the device resulted in the noted separated outer member likely contributing to the reported difficulties.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
• Common Device Name: 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: 19340341
• Report Number: 2024168-2024-06005
• Device Sequence Number: 7339591
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)250831(10)3091361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 1011344-40
• Device Lot Number: 3091361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown