MAUDE Adverse Event Report: AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22443-19

Device Problems Break (1069); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and dimensional inspections were performed.The reported dc pod damages were confirmed.The reported difficult to insert into the delivery catheter was unable to be confirmed due to the pod damage.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 similar incidents reported from this lot.Difficulty loading the filtration element into delivery catheter pod during preparation can be affected by numerous factors including, but not limited to, damage to the pod, the pod inner diameter may be too narrow, the pod length may be too short, the pusher length may be too long, the loading funnel inner diameter may be too narrow, not using the torque device, physician technique.The investigation was unable to determine a cause for the initial difficulty to insert.In this case, it is possible that the technique used to pull the barewire to load the filtration element into the pod was too hard causing the filter to bunched creating resistance with the pod and not allowing the filter to load.Manipulation and/or inadvertent mishandling during attempts to load the filter possibly resulted in the filter frame/structure assembly break; however, this could not be confirmed.Although a conclusive cause for the initial difficulty to insert could not be determined; the dc pod and barewire damage appear to be related to circumstances of the procedure during loading.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a mildly tortuous lesion in the internal carotid artery.Difficulty inserting the filter into the delivery catheter pod was felt during preparation of an emboshield nav6 embolic protection devices (epd).A second nav6 epd was being prepared; however, difficulty inserting the filter into the delivery catheter pod was felt.The delivery catheter wrinkled and the tip kinked.There was no patient involvement with either device.The procedure was successfully completed with an unspecified filter.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis for the second used nav6 epd identified that a broken strut was noted on the filtration element support structure.No part of the support structure appeared missing.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION 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: 8714170
• MDR Text Key: 148530586
• Report Number: 2024168-2019-04874
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 22443-19
• Device Lot Number: 8053061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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