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

Catalog Number 22443-19

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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.It should be noted the emboshield nav6 embolic protection system electronic instructions for use (eifu) warns: ¿only use the barewire filter delivery wires.Use of other guide wires will lead to loss of the filtration element or an inability to retrieve the filtration element.¿use of the incorrect guidewire contributed to the reported difficulties.Based on the information provided, the investigation determined that the reported difficulties were user related.The difficulty retrieving the filter was due to the user advancing the emboshield nav6 onto a command guidewire and failing to use the provided barewire filter delivery wire as instructed in the product ifu resulting in the need for additional unexpected medical intervention to retrieve the filter.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 in the right superficial femoral artery with heavy calcification and mild tortuosity.The large emboshield nav6 embolic protection system (eps) was loaded onto a command guidewire (gw) without the barewire and advanced to it's intended location.When it was realized that the eps was not on the barewire the physician advanced a non-abbott gw beyond the eps filter and then advanced a 4.00mm balloon on the wire also passed the filter.The balloon was then inflated to push up against the filter so that the filter could be retrieved from the patient.There was no adverse patient sequela.Another emboshield nav6 was used to continue the procedure.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: 16117422
• MDR Text Key: 306877880
• Report Number: 2024168-2023-00262
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2023

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 Catalogue Number: 22443-19
• Device Lot Number: 1121561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Treatment: 4.00 BALLOON; 6F GUIDE CATHETER; NON-ABBOTT GUIDEWIRE
• Patient Outcome(s): Required Intervention