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

Model Number 22437-19

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly calcification, mildly tortuous de novo left internal carotid artery that is 90% stenosed.The emboshield nav6 embolic protection system (eps) was advanced and after reaching the lesion site, it was noted that the tip of the barewire was bent.After removing the device the tip of the bare wire was uncoiling.A new emboshield nav6 was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.

Event Description

Subsequently, after the initial was filed per device analysis it was noted the delivery catheter was oversized.No additional information.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported break was not confirmed; however, the tip coils were stretched which was likely the damage observed from the user.Additionally, the tip coils were sporadically misaligned which was likely the bend appearance that was reported.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 reported information, the investigation determined that the damage to the barewire tip likely occurred during advancement into the 90% stenosed lesion.Additionally, it may be possible that after removing the delivery catheter for inspection and adjustment, the filter came off from the barewire and was placed back on the barewire inverted.There was no indication of difficulty loading the filter into the delivery catheter suggesting that the inverted filter was not a pre-existing condition.Further, it is possible that the delivery catheter returned for evaluation was from another opened unit, possibly the second unit used in this case.Testing was done by the business unit to replicate loading an inverted small sized filter into a large sized delivery catheter.The results concluded that on average, it requires ~2x more force to load an inverted small filter in to a large dc.This observation was not noted in the reported complaint information which provides evidence that the device was likely not manufactured in this state (inverted and mismatched dc).In conclusion, there is no indication of a product quality issue with respect to the design, manufacture, or labeling.

• 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: 15934775
• MDR Text Key: 305818851
• Report Number: 2024168-2022-12347
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 2040461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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