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

Model Number	1011344-40
Medical Device Problem Codes	Material Separation (1562); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported tip separation was confirmed.The stent malaposition could not be confirmed as it was based on procedural conditions and the stent was not returned.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 complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulty.It may be possible that the stent was not fully apposed due to narrowing of the vessel.Additionally, it may be possible that due to the stent being narrowed, the tip of the acculink was unable to be pulled back through the stent resulting in separation.However, this could not be confirmed.The additional treatment to attempt to retrieve the separated tip and outcome of embedding the separated tip to the vessel wall appear to be due to circumstances of the procedure.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 reported that the procedure was performed to treat a lesion in the non-calcified, non-tortuous right internal carotid artery.A 7-10x40mm acculink self-expanding stent system (sess) was advanced, and the stent was deployed.The stent had not fully apposed to the vessel wall, and it was noted that the tip had separated.A snare was attempted to remove the separated tip but was unsuccessful.An unspecified stent was to embed the tip and fix the poorly apposed acculink stent to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.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
• MDR Report Key: 11298193
• Report Number: 2024168-2021-00986
• Device Sequence Number: 17383515
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0082661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100