MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number	1011344-30
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The emboshield nav6 referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous and mildly calcified right carotid artery.A 190 cm emboshield nav6 embolic protection system (eps) was used along with a 7-10 x 30 mm acculink ii self-expanding stent system.The devices did not meet any resistance during advancement.The stent was implanted and a 4.0 x 30 mm and a 5.0 x 20 mm viatrac balloon dilatation catheter were used for pre and post-dilatation.However, during an attempt to retrieve the filtration element, it became caught with the distal part of the stent and there were several unsuccessful attempts to remove the filtration element.Then, the filtration element inadvertently explanted the stent and both devices were inadvertently removed as a single unit.The stent could not be located and it was not in the trash can.Fluoroscopy and x-ray were also done; however, the stent was not found inside the anatomy either.Additionally, the stent was not found in the guide wire filter of the emboshield nav6 device.Therefore, another unspecified emboshield nav6 eps and an acculink stent were used to successfully complete the procedure.There was a clinically significant delay in the procedure; however, the patient was stable.No additional information was provided.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7801057
• Report Number: 2024168-2018-06403
• Device Sequence Number: 11202058
• Product Code: NIM
• UDI-Device Identifier: 08717648076381
• UDI-Public: 08717648076381
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 03/31/2020
• Device Catalogue Number: 1011344-30
• Device Lot Number: 8040561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FILTER: EMBOSHIELD NAV6
• Patient Age: 81 YR
• Patient Weight: 98