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

Model Number 22438-19

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 12/24/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a lesion in the heavily tortuous and heavily calcified internal carotid artery.The emboshield nav6 embolic protection device filter was deployed without difficulty.However, while advancing the retrieval catheter, due to the anatomy the retrieval catheter could not reach the filter.The 8f guiding catheter that was already in the body was advanced to the filter then pull backed the barewire until the filter was completely inside the guiding catheter.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.There was no damage noted to the filtration element.There was no damage noted to the delivery catheter.The barewire-core was bent proximal to the barewire-step.The barewire-coils were bunched proximal to the barewire-step.The barewire-coils were wavy sporadically from the barewire-step to the distal tip.The retrieval catheter was received with the tray.No damage was noted to the retrieval catheter.The filtration element was loaded into the expandable tip of the retrieval catheter.The filtration element was retrieved with no resistance nor anomalies noted.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 revealed no other complaints reported from this lot.Based on the information provided, the failure to advance and difficulty removing the retrieval catheter appears to be due to challenging anatomical conditions, which were described as heavily tortuous and heavily calcified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 13262404
• MDR Text Key: 284190740
• Report Number: 2024168-2022-00536
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0110961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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