MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Catalog Number	1011342-30
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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 that the procedure was to treat an internal carotid artery.An acculink was advanced to the lesion with no resistance noted and deployment was activated.However, resistance was noted with the thumbslide although the stent was already a little out of the sheath (partially deployed).The physician stopped and decided to remove the device.Some resistance was met with the anatomy during removal.Once removed outside of the anatomy, it was noted that the stent came off completely.It did not remain in the anatomy.A second stent was deployed without issue to successfully complete the procedure.There was no clinically significant delay or adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported difficulties were 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 reported difficulties were likely related to procedural circumstances.The difficulty removing and stent dislodgment are the result of retracting the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACCULINK
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9173205
• Report Number: 2024168-2019-12469
• Device Sequence Number: 2323747
• Product Code: NIM
• UDI-Device Identifier: 08717648076343
• UDI-Public: 08717648076343
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 05/31/2021
• Device Catalogue Number: 1011342-30
• Device Lot Number: 9061361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 60