MAUDE Adverse Event Report: ABBOTT VASCULAR INC. EMBOSHIELD NAV6; Temporary Carotid Catheter for Embolic Capture

Model Number	22438-19
Medical Device Problem Codes	Retraction Problem (1536); Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a stenosed lesion in the internal carotid artery (ica).The large emboshield nav 6 embolic protection system (eps) was advanced to the intended location and a stent was implanted.Post stent implantation, the filter was attempted to be retrieved into the retrieval catheter when the barewire fractured resulting in the filter becoming separated and remaining in the distal ica.Therefore, the patient was transferred to vascular surgery, and open surgical arteriotomy was performed to remove the barewire separation and filter.The patient experienced bleeding which was resolved via routine heparin during surgery.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, based on the reported information, the reported difficulties appear to be due to circumstances of the procedure.The difficulty retrieving the filter into the retrieval catheter and separation of the barewire appear to be due to an excessive embolic load preventing the filter from being able to fully collapse into the retrieval catheter during removal resulting in separation of the barewire tip and causing the filter to remain in the distal internal carotid artery (ica).As a result, surgical intervention was required to remove the separated barewire tip and filter and the patient experienced bleeding which was resolved via routine heparin during surgery.The reported patient effects of surgery and bleeding are listed in the emboshield nav6 instructions for use, as known potential adverse events associated with carotid stents and embolic protection systems.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.

• 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 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50016651
• Report Number: 2024168-2026-02935
• Device Sequence Number: 21234191
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: (01)08717648137754(17)280831(10)5092561
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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 Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 5092561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown