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

Catalog Number 1011344-30

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2018

Event Type  malfunction  

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 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
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7801057
• MDR Text Key: 117726839
• Report Number: 2024168-2018-06403
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076381
• UDI-Public: 08717648076381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 1011344-30
• Device Lot Number: 8040561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FILTER: EMBOSHIELD NAV6
• Patient Age: 81 YR
• Patient Weight: 98