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

Catalog Number	22437-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Obstruction/Occlusion (2422)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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.In this case, there was no reported device malfunction associated with the emboshield nav6.The reported patient effects of occlusion and stroke are listed in the emboshield nav6 instructions for use, as known potential complications associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effect(s) of occlusion and stroke, and the relationship to the product, if any, cannot be determined.The reported treatment with medication and prolonged hospitalization appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat the internal carotid artery that is 95-99% stenosed.The emboshield nav6 embolic protection system (eps) was advanced and deployed successfully.Angioplasty was performed and blood flow was noted to be good.An unspecified stent was deployed, followed by a second angioplasty; however, the blood would flow up the common carotid, but once it reached the stent it would stop.Once the filter was retrieved blood flow was restored through the stent and into the brain.It is believed that the deployed filter was causing an occlusion within the stent.The patient was noted to experience small strokes following the procedure and was provided medication.The patient stayed several extra days overnight in the hospital as a result.No additional information was provided.

• 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: 19158555
• Report Number: 2024168-2024-04959
• Device Sequence Number: 15443856
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: (01)08717648137747(17)270131(10)4020961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 22437-19
• Device Lot Number: 4020961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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; Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Hispanic