MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS

Model Number FNAV-DS-LG

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 06/09/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being for the iliac rupture that lead to death.It was reported that a 27mm navitor valve was selected for implant on (b)(6) 2022 using a large flexnav delivery system.The patient had general tortuous aorta.There was sufficient calcium to allow for anchoring of the valve.During the procedure as the valve was released, the valve migrated.The implant depth at deployment and release was 2-4mm.It was noted that there was no tension in the delivery system at the time of final deployment but that the physician pushed the delivery system slightly too forward during final release causing it to hook on to the retainer tabs if the navitor valve.During removal of the delivery system, the valve migrated.The valve was not snared.The migrated valve did not block any coronary arteries.The patient did not experience any symptoms due to the migration and remained hemodynamically stable.A 2nd, 27mm navitor valve was required in a valve in valve procedure using a new large flexnav delivery system.While advancing the large flexnav delivery system in the calcified and tortuous arteries, the iliac artery was damaged.The damage was thought to have been related to the delivery system progression in the tortuous anatomy.A vessel repair was attempted but to due significant bleeding the patient died during the procedure.The cause of death was iliac rupture during the valve in valve attempt.Related manufacturing reference number 2135147-2022-00480-00, 2135147-2022-00539-00.

Manufacturer Narrative

An event of the iliac artery was damaged while advancing the delivery system was reported.A returned device assessment, to see if there was any damage or anomalies which could have contributed to the reported event could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, but is consistent with vessel damage while advancing the delivery system.

• Brand Name: FLEXNAV DS
• Type of Device: FLEXNAV DS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15063472
• MDR Text Key: 296207454
• Report Number: 2135147-2022-00548
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death