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

Model Number 22437-19

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a procedure using the emboshield nav6 embolic protection device (epd) in the right carotid artery with 99% stenosis.After the non-abbott stent was deployed, the barewire was advanced and the filter stayed in place.The physician forgot that the nav6 filter was independent of the barewire and thought the filter had broken off the wire.A snare was used to retrieve the filter; however, once out of the anatomy, it was confirmed that the filter was still on the barewire.The physician still feels that something on the device was broken.There was no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed.The reported damage to 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 similar complaints.The investigation determined that the reported difficulties were likely related to case circumstances.It may be possible that the filter moved back on the barewire proximal to the step, possibly due to interaction with the previously placed stent, giving the appearance that the filter had detached from the barewire.The damage noted to the returned filtration element and barewire tip coils likely occurred during removal of the device with use of a snare instead of the provided retrieval catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: catalog no, udi#.

• 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
• MDR Report Key: 10901349
• MDR Text Key: 218236468
• Report Number: 2024168-2020-09910
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0090461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: BOSTON SCIENTIFIC WALLSTENT; STENT: BOSTON SCIENTIFIC WALLSTENT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82