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

Model Number	1011344-40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar complaints.The investigation determined that the reported difficulties and subsequent treatments were related 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.The nav6 referenced is filed under a separate mfr report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left carotid artery that was calcified and tortuous.The emboshield was positioned and deployed distal to the lesion without any issues.The acculink stent was advanced to the lesion.The sheath was re-positioned but lost position, resulting in the stent deploying in an unintended location, possibly in the left common carotid.The stent delivery system was removed without issue.While pulling the emboshield filter toward the sheath, it became entangle with the implanted stent.Attempts were made to advance the retrieval catheter, but because the filter was entangled with the stent, it could not be collapsed into the retrieval catheter.The patient was taken to surgery for removal of the filter and stent.No additional treatment was provided, and the patient remains in good condition.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: 10059898
• Report Number: 2024168-2020-04337
• Device Sequence Number: 2826573
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 12/31/2021
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 0010761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/14/2020
• 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: 84 YR
• Patient Weight: 96