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

Catalog Number 22443-19

Device Problems Break (1069); Difficult to Insert (1316); Material Twisted/Bent (2981)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported damage to the delivery catheter and filter was confirmed.The reported difficult to insert was unable to be confirmed due to the condition of the returned unit.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 indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty.It may be possible that the filter was pulled into the pod too quickly or with excessive force causing damage to the delivery catheter pod and damage to the filter support structure preventing the filtration element from being able to load properly; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.

Event Description

It was reported that during preparation of the emboshield nav6 embolic protection system (eps), there was difficulty noted when attempting to insert the filter into the delivery catheter pod; therefore, the filter was unable to be loaded.Bunching was noted after attempting to load the filter.Another eps was used to successfully continue the procedure.There was no patient involvement reported and no clinically significant delay reported.Per device analysis it was identified that filtration element support structure was broken, but not separated into two separate pieces.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: 18704050
• MDR Text Key: 335366989
• Report Number: 2024168-2024-01808
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 2090961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• 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