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

Catalog Number 22443-19

Device Problems Off-Label Use (1494); Difficult to Remove (1528)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported difficulty to remove the barewire could not be confirmed as the exact conditions encountered by the device during the procedure could not be replicated in a testing environment as it was based on operational circumstances.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 indication of a lot specific product quality issue.Reportedly, the emboshield nav6 eps was being used to treat a lesion in the calcified distal femoral artery, it should be noted that the emboshield nav 6 instruction for use states: the emboshield nav6 rapid exchange (rx) embolic protection system is a temporary percutaneous transluminal filtration system designed to be used as a guide wire and to capture embolic material released during an angioplasty and stent procedure within a saphenous vein bypass graft or a carotid artery.In this case, it is unknown if the reported ifu violation contributed to the reported difficulties.Based on the information provided, the difficulty removing, and subsequent stretched tip coils and break were likely due to circumstances of the procedure.In this case, it is likely that clearance between the inner diameter of the jetstream device and outer diameter of the barewire became reduced during use resulting in the devices becoming stuck together causing difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The barewire device referenced is filed under a separate medwatch report.

Event Description

It was reported that the atherectomy procedure was to treat a mildly tortuous, heavily calcified distal femoral in-stent stenosis.The emboshield nav6 barewire was exchanged for a longer barewire to be used.The barewire was advanced to the target lesion and the procedure was completed.At the end of the procedure, when a non-abbott atherectomy device was being removed, it met resistance with the barewire.Once the barewire was removed, it was noted to be damaged badly at the distal end (unraveled, stretched).It was confirmed there were no issues with the use of the emboshield nav6 device.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information from the account and device analysis confirmed: [when removing the jetstream there was a resistance with the barewire.When attempting to remove the filter and retrieval catheter over the bare wire, it was unable to do so, therefore the barewire was removed altogether with the filter and retrieval catheter as one as device analysis noted the devices were returned frozen together.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: 15612408
• MDR Text Key: 306593791
• Report Number: 2024168-2022-10658
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 2052462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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
• Treatment: BAREWIRE 315CM; JETSTREAM ATHERECTOMY