MAUDE Adverse Event Report: ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM

Catalog Number	22440-31
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the nav6 filter was placed in the popliteal artery without issue using the barewire.A non-abbott 4.0x60 intravascular lithotripsy balloon was advanced over the barewire and balloon dilatation was performed at the superficial femoral artery.An attempt was made to pull the ivl balloon off the barewire; however it was stuck on the wire.As the ivl was stuck on the wire, a retrieval catheter was unable to be used to retrieve the filter; therefore the entire system had to be removed all together (barewire, ivl, nav6).A drug coated balloon was advanced over a different guide wire to further treat the vessel.A final angiogram was taken and a distal embolism was noted in the foot.The procedure was prolonged as tpa medication was intravascularly injected to treat the embolism.In the physicians opinion, the nav6 did not cause the embolism.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported difficult to remove was unable to be tested due to device condition.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported event description and evaluation of the returned unit, the reported difficulty removing appears to be due to circumstances of the procedure.It is likely that clearance between the guide wire lumen of the non-abbott ivl (intravascular lithotripsy) balloon catheter and the barewire was reduced during use causing the devices to become stuck requiring that the entire system be removed together.A definitive cause for the embolism could not be determined; however, in the physician¿s opinion, the nav6 did not cause the embolism.Reportedly, tpa medication was intravascularly injected to treat the embolism.The reported patient effect of embolism is listed in the emboshield nav 6 instruction for use (eifu) as a known potential adverse effect associated with the use of carotid stents and embolic protection systems.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Common Device Name: 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: 19004106
• Report Number: 2024168-2024-03892
• Device Sequence Number: 18505941
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: (01)08717648137808(17)260131(10)3020261
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 22440-31
• Device Lot Number: 3020261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0X60 INTRAVASCULAR LITHOTRIPSY BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown