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

Catalog Number 22443-19

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2022

Event Type  Injury  

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.

Event Description

It was reported this was a procedure to treat a mildly tortuous right internal carotid artery.An emboshield nav6 was inserted without issues.One stent was successfully placed at the target lesion.While attempting to remove the nav6 filter, once the retrieval catheter was removed from the guide catheter, it was noted that the filter had detached and remained in the anatomy, resulting in a clinically significant delay in the procedure.It was confirmed via x-ray imaging that the filter was roughly 5cm above the bifurcation.The distal tip of the bare wire was also observed to be stretched.An attempt to remove the filter was made after about 4 hours, - after neuro-consultation.A lasso catheter was then inserted, but the filter was unable to be retrieved.Surgical intervention was discussed, but due to the high risk to the patient, no additional treatment was performed.The patient is in stable condition.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported material separation and stretched coils were confirmed.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 similar complaints.The investigation was unable to determine a cause for the reported difficulties resulting in unexpected medical intervention, delay in procedure and foreign body left in patient.It may be possible that the barewire core separated as the filter was being retracted into the retrieval catheter due to a large embolic load preventing the filter from being able to collapse enough to pull into the retrieval catheter; however, this could not be confirmed.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: 13753541
• MDR Text Key: 287115882
• Report Number: 2024168-2022-02600
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2022
• 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: 1120662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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: BAREWIRE; FORTRESS 6F GUIDE CATHETER (BIOTRONIK)
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White