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

Model Number 22438-19

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.It should be noted the emboshield nav6 embolic protection system electronic instructions for use 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 deviation of the ifu does not appear to have caused/contributed to the reported difficulties.Based on the information provided, the investigation determined that the reported difficulty was likely due to case circumstances.It is possible that the non-barewire guide wire gave way when pulling the wire back, possibly separating and consequently the filter came completely off; however, this cannot be confirmed.Based on additional information from the account, the non-abbott wire (the csi viper wire) has a.017 step up that would prevent the filter from coming off the wire.Although the step on the barewire filter delivery wire is larger at 0.019¿, it could not be determined if using the non-abbott guide wire caused or contributed to the difficulty.The embedded device and removing portion of the wire by snare are also 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 popliteal lesion where a previously implanted non-abbott stent became fractured.Per the physician, the plan was to implant another non-abbott stent.During the procedure, a non-barewire snapped off (2 pieces) when pulling the wire back, and consequently the emboshield nav6 filter came completely off the wire.The physician simply removed the proximal portion of the wire, and through another access site snared the distal portion of the wire.It was decided to then embed the filter next to the other non-abbott stent, right behind it.There was no patient sequela and no clinically significant delay reported.No additional information was provided.

• Brand Name: EMBOSHIELD NAV6
• 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: 10844938
• MDR Text Key: 216408971
• Report Number: 2024168-2020-09564
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CSI VIPER WIRE; VIABHAN STENT
• Patient Outcome(s): Required Intervention