MAUDE Adverse Event Report: ABBOTT VASCULAR INC. EMBOSHIELD NAV6; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	22437-19
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the right internal carotid artery with 90% stenosis.The emboshield nav6 embolic protection system (eps) was deployed normally in the carotid artery but could not be retrieved at the end of the procedure as when the intact barewire was removed, the filter remained inside the patient.An additional stent was implanted to embed the filter into the vessel.The patient was hospitalized additional time.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.In this case, a definitive cause for the reported filter dislodgment could not be determined.It may be possible that filter was carrying an excessive embolic load preventing the filter from fully collapsing into the retrieval catheter and while pulling the barewire, a separation of the barewire at the step occurred resulting in dislodgment of the filter.However, without having the device returned for evaluation, this could not be confirmed.The unexpected medical intervention to embed the filter into the vessel resulting in prolonged hospitalization was related to circumstances of the procedure.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported filter dislodgement was confirmed as the barewire was returned without the filter.In addition, video and images were provided and were reviewed.Production record and corrective and preventative 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.In this case, a definitive cause for the reported filter dislodgment could not be determined.It may be possible that filter was carrying an excessive embolic load preventing the filter from fully collapsing into the retrieval catheter and while pulling the barewire, dislodgment of the filter occurred.However, this could not be confirmed.The videos provided do not show when or how the filter was reportedly dislodged from the barewire.The unexpected medical intervention to embed the filter into the vessel resulting in prolonged hospitalization was related to circumstances of the procedure.Cine images and video were provided and reviewed by an abbott clinical advisor.The videos and images provided do not explain why the nav6 filter could not be retrieved after stent deployment.Due to the poor quality of the cellphone videos, it cannot be determined if a second wire was used to advance and deploy the stent.It does appear that the filter is proximal to the stent in the first couple of videos provided.However, since the images provided were not the full procedural images, as opposed to cellphone recorded videos, it cannot be definitively stated that the nav6 was in the proper location prior to the initial stent deployment or why the filter could not be retrieved.The videos provided do not show when or how the filter was reportedly dislodged from the barewire.The videos do not show any attempt to retrieve the nav6 with the provided retrieval catheter or any other device such as a snare.Therefore, it is unknown how the retrieval was attempted.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: corrected device returning from no to yes.G2: report source added other, national medical products administration.H6: component code 4755 was removed.H6: investigation findings code 3221 was removed.H11: additional manufacturer narrative: revised.

• Brand Name: EMBOSHIELD NAV6
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 23512026
• Report Number: 2024168-2025-11435
• Device Sequence Number: 15941329
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)271231(10)5011661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 5011661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown