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

Model Number	1011344-40
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous internal carotid artery that is 95% stenosed.The lesion was prepped with a 4x20mm viatrac balloon inflated to 8 atmospheres for 2 seconds.The 7-10x40mm acculink self-expanding stent system (sess) was advanced to the target lesion and the safety lock was turned counter-clockwise to the deployment position.The handle was pulled back to deploy the stent; however, the stent completely failed to deploy.The acculink was withdrawn under fluoroscopy and replaced with a 9-7x40mm xact stent to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis revealed the stent was returned partially deployed, with distal end ring 1 strut exposed from the sheath.There was shaft separation from the slider noted once the handle halves were opened.The shaft separation remained in one piece as shaft was still held together by the hypotube.
Additional Manufacturer Narrative
The device was returned for analysis and the shaft was noted to be separated.The reported activation failure and mechanical jam were able to be 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 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 during advancement interaction with the moderately calcified, moderately tortuous and 95% stenosed anatomy and/or inadvertent mishandling resulted in the noted wrinkled sheath and the noted multiple shaft bends on its entire length; thus preventing the shaft lumens from moving freely, resulting in resistance with the slider (mechanical jam) and difficulty deploying the stent (activation failure).Manipulation of the device resulted in the noted shaft bunching and shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 14311164
• Report Number: 2024168-2022-04932
• Device Sequence Number: 20151991
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: 05/31/2023
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 1060261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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