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

Catalog 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	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.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/noted difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the heavily calcified, heavily tortuous and 95% stenosed anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in resistance with the slider and the difficulty deploying the stent.Manipulation of the device ultimately resulted in the noted hypotube separation contributing to the reported difficulties.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that the procedure was to a 95% stenosed lesion in the internal carotid artery (ica) with heavy calcification and heavy tortuosity.The 6-8x40mm acculink self expanding stent system (sess) was advanced; however, the stent failed to deploy because the thumbslide was stuck.Another acculink sess was used in the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found that the hypotube was separated inside the handle.No additional information was provided.

• 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: 18259135
• Report Number: 2024168-2023-13413
• Device Sequence Number: 7859432
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/04/2023

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: 07/31/2024
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2081961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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