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)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to advance was not confirmed/ tested as it cannot be replicated due to anatomy.The reported kink was not confirmed.There was additional noted damage to the shaft as it was separated and exposed misaligned coils and a bent core.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 query of the complaint handling database for the reported lot revealed no indication of a lot specific product quality issue.The investigation determined that the reported difficulties appear to be due to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulty advancing.Additionally, the damage noted to the delivery catheter and barewire coils is likely contributed to failed attempt to reach the desired location as reported.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 heavily calcified lesion in the right internal carotid artery.An emboshield nav6 embolic protection system (eps) was advanced; however, resistance with the anatomy was felt.Once at the desired location, it was noted that distal part of the deliver catheter was kinked.Upon noticing this, the delivery catheter and the filter were retrieved without attempting to deploy the filter.Another emboshield nav6 eps was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis identified that the shaft of the delivery catheter was separated 1mm proximal to the distal marker.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: 11888777
• MDR Text Key: 264502508
• Report Number: 2024168-2021-04431
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 22443-19
• Device Lot Number: 1010861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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