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

Model Number 22437-19

Device Problems Material Separation (1562); Activation Failure (3270); Material Split, Cut or Torn (4008)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous internal carotid artery.The emboshield nav6 embolic protection system (eps) was advanced to the lesion; however, the filter could not be deployed.The eps was withdrawn and another eps was advanced; however, the same issue occurred.The procedure was completed without treatment.There was no adverse patient effects reported and no clinically significant delay reported.Per device analysis of the first eps used in the procedure it was noted one of the emboshield nav6 the dc pod was separated, 0.5 millimeter (mm) proximal to the marker.The separated proximal portion of dc pod was 50mm proximal to the noted separation and proximal to the exposed pusher.The pod material at the separation was stretched and uneven.Per returned device analysis of the second eps used in the procedure it was noted that the delivery catheter (dc) pod was separated, proximal to the marker.The separated proximal portion of dc pod was 4cm proximal to the noted separation and proximal to the exposed pusher.The pod material at the separation was stretched and uneven.The dc pod was torn proximal to the noted separation.It was confirmed both eps separated during the procedure per the account.No additional information was provided.

Manufacturer Narrative

The additional vascular device referenced are filed under separate medwatch report number.Visual analysis was performed on the returned product.The reported separation of the delivery catheter (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 identified no indication of a lot specific product quality issue.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 dc was restricted or entrapped within the heavily calcified and heavily tortuous anatomy, and during positioning, the separation occurred resulting in deployment failure; however, this could not be confirmed.The pod material was pinched in multiple locations, throughout its entire length distal to the marker further suggest that the pod may have been restricted within the heavily calcified lesion causing the damage.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.

• 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: 15335955
• MDR Text Key: 299953067
• Report Number: 2024168-2022-09307
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 2020261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2022
• 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