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

Model Number	1011343-40
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	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat the heavily calcified, heavily tortuous lesion in the left internal carotid artery.When attempting to deploy the stent, after unlocking the lock, the pullback handle did not slide back, and the stent did not deploy.The user tried so hard to deploy the clip that the handle broke apart.The device was removed without issue.There was no adverse patient effect and no clinically significant delay during the procedure.The procedure was completed with balloon angioplasty.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device the reported break was able to be confirmed.Additionally, the shaft was noted to be kinked and bent.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 similar 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 heavily calcified and heavily tortuous anatomy and/or inadvertent mishandling resulted in the noted wrinkled sheath; 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 kinked and bent shaft and ultimately resulted in the reported/noted handle break.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: 14596853
• Report Number: 2024168-2022-05952
• Device Sequence Number: 17493793
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 05/31/2022
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 0062362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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: Female