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

Catalog Number 1010129-40

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Describe event or problem continued: the return device analysis for the 8x40mm acculink ii sess identified that the stent implant was returned partially deployed for a length of 1cm.The inner member had separated 4mm proximal to the distal end of the stent holder.The separated portion, including the tip, was not returned.Follow-up with the account confirmed the separation occurred during the procedure in the guiding catheter during removal when resistance was felt.No additional information was provided.The additional emboshield and acculink devices are being filed under separate medwatch reports.Evaluation summary: visual and functional inspections were performed on the returned device.The reported difficulty to deploy or broken handle were unable to be confirmed.The reported separation was confirmed.The fractured faces at the separation were stretched and jagged and if pulled apart prior to separation.The reported difficulty to remove from the guiding catheter was unable to be confirmed since the stent was deployed during functional testing prior to the additional information regarding resistance.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 similar incidents were reported for this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.In this case, based on the reported information, it is likely that that the distal sheath was entrapped or restricted within the heavily tortuous anatomy causing resistance and preventing the handle slider from retraction and deploying the stent and the difficulty to remove.The reported separation and subsequent damages were likely the result of manipulation and/or inadvertent mishandling of the device during retraction through the guiding catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a heavily tortuous lesion in the internal carotid artery.It was noted that an emboshield nav6 embolic protection system (eps) was being advanced though the guiding catheter; however, resistance was felt.The nav6 eps was removed and a kinked on the tip of the delivery catheter was noted.A second emboshield nav6 eps was advanced; however, resistance with the very tortuous aorta was felt.An attempt to deploy the filter was made, but it could not be deployed.The nav6 eps was removed with resistance.A 6-8x40mm rx.014 acculink ii self-expanding stent system (sess) could not be deployed because the deployment mechanism felt very hard when attempting to pull it back.An attempt to use an 8x40mm.014 acculink ii sess was made; however, the handle was broken.The procedure was stopped and the patient is fine.There were no adverse patient effects and no clinically significant delay in the procedure.The following additional information was received: the return device analysis for the second nav6 eps used identified that the delivery catheter white pull handle was detached from the handle.Follow-up with the account confirmed this occurred when the device was out of the patient anatomy while an attempt to confirm if the filter could be deployed.The return device analysis for the 6-8x40mm rx acculink ii sess identified that the hypotube was separated 94.3cm distal to the strain relief tubing, but the outer member was still intact and was kinked at the hypotube separation.Follow-up with the account confirmed this damage occurred during the procedure.

• 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: 8437121
• MDR Text Key: 139364482
• Report Number: 2024168-2019-02165
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• 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: 1010129-40
• Device Lot Number: 8040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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