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

Model Number 22438-19

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2022

Event Type  Injury  

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.

Event Description

It was reported that the procedure was to treat the distal superficial femoral artery.During removal of the emboshield nav6 filter, resistance was noted with the anatomy, and the filter was unable to be pulled back in the retrieval catheter.It was then decided to pull the filter all the way up to the common femoral artery where the procedural sheath was and it was attempted to pull the filter into the sheath.However, once removed, it was noted that the filter membrane appeared to be missing.Via imaging it was noted the membrane remained in the anatomy and thus decided to be stented up against the common femoral wall.A final angiogram was performed and showed normal bloodflow throughout the leg.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficult to remove was not confirmed due to the condition of the returned unit.The reported material separation of the filtration element 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 other similar complaints reported from this lot.Based on the reported event description and analysis of the returned unit, the resistance during removal and separation of the filtration membrane resulting in unexpected medical intervention to embed the filter membrane against the common femoral wall appears to be due to circumstances of the procedure.It may be possible that the filtration element was carrying an excessive embolic load resulting in resistance during the attempt to retract the filter into the retrieval catheter.As a result, the filter was pulled all the way up to the common femoral artery where the procedural sheath was.It is likely that during withdrawal of the expanded filter, interaction with the anatomy or sheath caused the filtration membrane to detach from the support structure resulting in additional intervention to embed the separated membrane against the vessel wall.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: 15821318
• MDR Text Key: 303896045
• Report Number: 2024168-2022-11759
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 2091261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG