MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DS; LARGE FLEXNAV DELIVERY SYSTEM

Model Number FNAV-DS-LG

Device Problems Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/16/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022 a portico valve was implanted in a patient.During the procedure, it was attempted to recapture the portico valve using the lg flex nav delivery system.After several failed attempts, it was decided to withdraw the device and delivery system from the patient.When the delivery system reached the iliac region, it became stuck.The pressure behind the device caused an iliac laceration, requiring surgical intervention.The treatment was two covered stents, however the patient died due to heavy bleeding.

Manufacturer Narrative

An event of difficulty retracting delivery system and patient death due to heavy bleeding was reported.A returned device assessment 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.One video taken during imaging was received from field that appeared to show retraction of delivery system while the struts of the valve could be seen.Two other videos appearing to show the re-sheathing of bloody valve on operating table.From the video and image, there appears to be tissue from right iliac artery shown on the sheath.B5.Event description updated with additional information.H6.Medical device problem code: 2993 code removed.H6.Medical device problem code: 2135 perforation of vessels added.

Event Description

It was reported that on (b)(6)2022, a portico valve was chosen for implant using a flexnav delivery system for an aortic valve replacement due to severe aortic stenosis.After initial partial deployment of the valve at 80%, the valve needed to be recaptured for better positioning.The delivery system did not fully recapture the valve, leaving a distance of approximately 6mm to complete the maneuver.After several unsuccessful attempts for the system to completely recapture the entire valve, the decision was made to withdraw the delivery system along with the partially recaptured valve.When the delivery system reached the right iliac region, it became stuck.It was noted that there had been severe calcification in the right iliac artery.The pressure behind the device caused an iliac laceration or perforation of the vessel, which required surgical intervention.Even after implanting two covered stents, the patient died due to heavy bleeding.No additional information was provided.

• Brand Name: FLEXNAV DS
• Type of Device: LARGE FLEXNAV DELIVERY SYSTEM
• 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: 14997670
• MDR Text Key: 295764603
• Report Number: 2135147-2022-00500
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: FNAV-DS-LG
• Device Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8100655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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
• Patient Sex: Female