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

Catalog Number	22437-19
Medical Device Problem Codes	Break (1069); Stretched (1601); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed lesion in the carotid artery.The small emboshield nav 6 embolic protection system (eps) was advanced to it's intended location; however, the physician noted that the eps did not feel as expected during advancement.Therefore, the eps was removed from the patient and the tip of the barewire was noted to have become unraveled.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another emboshield nav 6 eps was used to continue the procedure.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 device.The reported break to the barewire tip coils and stretching were confirmed.The reported unexpected feeling during advancement (material too soft/flexible) was unable to be confirmed as it was based on procedural circumstances due to the damage to the tip coils.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.The investigation determined that the reported barewire damage was likely due to circumstances of the procedure.It is likely that during advancement into the 80% stenosed lesion, the tip of the barewire likely became entrapped in the tight lesion resulting in the tip coil becoming stretched and the inner core to break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• 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: 19222938
• Report Number: 2024168-2024-05338
• Device Sequence Number: 15207954
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)261031(10)3111661
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 22437-19
• Device Lot Number: 3111661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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
• Patient Sex: Unknown