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

Model Number	1011344-40
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device which identified that the shaft was separated 7.5cm proximal to the distal end of the strain relief.The reported deployment issue was 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.The investigation determined that the deployment issue was related to circumstances of the procedure.The separation of the proximal outer member within the handle indicates that the distal shaft/sheath of the rx acculink was restricted preventing movement of the sheath during retraction of the slider.Further attempts to retract the slider with the distal sheath restricted likely caused the proximal outer member separation preventing transmission to the distal sheath and deployment failure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was report that the procedure was to treat a carotid artery.After pre-dilatation was performed a non-abbott embolic protection system was used.The lesion was pre-dilatated again and angiography revealed stenosis was significantly improved.A.014 rx acculink self expanding stent was advanced and once at the lesion the stent failed to deploy after many attempts.The physician decided to perform another procedure at a later date.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.Per device analysis it was observed that the shaft was separated 7.5cm proximal to the distal end of the strain relief.The hypotube was still intact holding both pieces together.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11349274
• Report Number: 2024168-2021-01322
• Device Sequence Number: 3302817
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 07/31/2022
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 0080361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1