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

Model Number 22438-19

Device Problems Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981); Migration (4003); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only the filtration element and non-abbott guide wire was returned.Visual and functional analysis was performed on the returned product.The reported difficulties were unable to be tested 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 identified no other similar complaints reported from this lot.It should be noted the emboshield nav6 embolic protection system electronic instructions for use (ifu) warns: the emboshield nav6 device can only be used with the barewire filter delivery wire.Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element.The barewire filter delivery wire contains a step which prevents the filtration element from coming off the wire.The ifu deviation likely caused the reported difficulty.Based on the information provided, the investigation determined that the reported difficulty was likely use related.Failing to use the provided barewire filter delivery wire as instructed in the product ifu resulted in the filter coming off the non-abbott guide wire during the attempt to retrieve.The damage noted to the filter likely occurred during the difficulty retrieving.The additional treatment to retrieve the filter was due to case circumstances.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 to treat a lesion located in the popliteal artery.The nav6 was positioned in the artery using a non-abbott wire instead of the barewire.During removal of a non-abbott balloon dilatation catheter (bdc), it caught with the proximal end of the filter and moved the filter within the artery; however, the bdc was removed successfully.During retrieval of the nav6 emboshield, it could not be pulled into the retrieval catheter, so a 6fr catheter was advanced and the nav6 was successfully removed.After removal, it was noted that the nitinol ring looked deformed.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

It should be noted the emboshield nav6 embolic protection system electronic instructions for use (ifu) warns: the emboshield nav6 device can only be used with the barewire filter delivery wire.Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element.The barewire filter delivery wire contains a step which prevents the filtration element from coming off the wire.The ifu deviation likely caused the reported difficulty.It could not be determined if using the nav6 with the non-abbott guide wire contributed to the reported difficulties.Based on the information provided, the investigation determined that the reported difficulties were likely related to case circumstances.The reported movement of the filter appears to be due to the non-abbott balloon dilatation catheter (bdc) being caught on the proximal end of the filter, causing the filter to move during removal of the bdc.It may be possible that the bdc was advanced too far up the non-abbott guide wire resulting in the tip of the bdc advancing over the proximal neck of the filter support structure.Additionally, the filter support structure likely became compromised during removal of the bdc with difficulty, resulting in further complications during retrieval and further damage to the support structure and filtration element as noted on the returned unit.The additional treatment to retrieve the filter was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: conclusion code 61 - removed h10: additional mfg narrative.

• 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: 10428797
• MDR Text Key: 203714513
• Report Number: 2024168-2020-06942
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 9071661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIPER GUIDE WIRE; VIPER GUIDE WIRE
• Patient Outcome(s): Required Intervention