MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22443-19

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that after device preparation, without issue, the filter was advanced into the common carotid artery; however, resistance was noted when advancing distal to the heavily calcified, moderately tortuous, 60% stenosed, de novo lesion in the right internal carotid artery (rica).Once at the parking place, deployment was attempted, but completely failed, so the device was removed without issue.Once outside the anatomy, it was noted that the tip of the filter was bent and separated.There was no adverse patient effect or clinically significant delay in procedure.A second device was prepped without issue.The filter was delivered without issue to it¿s parking spot and used without issue.After the acculink carotid stent was implanted, the filter was removed without issue, using the recovery catheter.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported difficult to advance was unable to be confirmed as it was based on circumstances of the procedure.The reported kink/bend was confirmed.The reported separation of the dc pod which may have contributed to deployment failure was confirmed.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 revealed no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.Based on the reported information and evaluation of the returned unit, the deployment failure may be the result of the separated distal shaft/dc pod.Although a definitive cause for the separation could not be determined, it may be possible that the distal shaft of the delivery catheter was restricted or entrapped within the heavily calcified and heavily tortuous anatomy, and during positioning with resistance, the separation occurred resulting in deployment failure; however, this could not be confirmed.There was no difficulty noted during preparation, and the filter was noted to be fully loaded into the dc pod suggesting that the damage was not pre-existing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial medwatch report, the following information was reported: it was reported that the procedure was to treat a heavily calcified, moderately tortuous, 60% stenosed, de novo lesion in the right internal carotid artery (ica).An emboshield nav6 embolic protection system (eps) was prepared without issue and advanced through the introducer, passed the lesion stenosis and passed the lesion tortuosity with slight resistance.The nav6 was desired to be left in this segment, so the filter could be deployed in the targeted ica region, however, it did not go further, the filter could not be deployed from the delivery catheter into the ica.The white handle was pulled back, and it was observed under imaging that the filter did not come to the open position.The white handle was brought back to its position and tried again, however; the filter did not open with the second attempt.The nav6 was removed with the delivery catheter, and it was found that the delivery catheter pod had separated [and it was moving on the guide wire].A new nav6 and an acculink carotid stent were placed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16368592
• MDR Text Key: 309581252
• Report Number: 2024168-2023-01452
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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 Catalogue Number: 22443-19
• Device Lot Number: 2021761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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: 0.038 CONGER GLIDE WIRE; 5F VERTEBRAL CATHETER; 6F NEUROCATCH LONG INTRODUCER