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

Model Number 22438-19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the left superficial femoral artery.An emboshield nav6 embolic protection system (eps) was deployed without issue, and laser atherectomy, multiple unspecified balloons, and multiple unspecified stents were used.There was a large amount of debris collected in the filter, and an embolism was noted.A non-abbott extraction catheter was used to aspirate and treat the thrombus.Another nav6 was used to successfully complete the procedure.There were no adverse patient sequelae but there was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.There were no anomalies noted on the returned filtration element.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of embolism is listed in the emboshield nav6 instructions for use (ifu) as a known adverse event potentially associated with carotid stents and embolic protection systems.Based on the case information, the reported embolism and delay in procedure appear to be related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10244669
• MDR Text Key: 197933065
• Report Number: 2024168-2020-05543
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 0020661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRONTO CATHETER; PRONTO CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR