MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number D-EVPROP34US

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 09/16/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: product id: evproplus-34us, serial/lot #: (b)(4), ubd: 18-mar-2022, udi#: (b)(4).Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior the implant of this 34 millimeter (mm) transcatheter bioprosthetic valve, it was reported the patient was unable to have a contrast computed tomography (ct), therefore an echocardiogram was used to determine the annular measurements and to size the valve.The valve was deployed into a native annulus with some leaflet calcification.Upon release, the valve dislodged into the ventricle.Using echocardiogram to size the valve may have contributed to the dislodgement.The valve was snared up distal to the aortic root.The patient was then taken to open heart surgery where the transcatheter valve was explanted.A non-medtronic surgical valve was implanted successfully.The patient was taken to the intensive care unit (icu) to recover.Nine days following the attempted transcatheter valve implant and open surgical repair procedure, the patient died as a result of heart failure.It was reported that both the attempted transcatheter valve implant and open surgical repair procedure contributed to the patient's death.An autopsy was not performed.

• Brand Name: EVOLUT PRO PLUS DCS
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10667203
• MDR Text Key: 210986623
• Report Number: 2025587-2020-03097
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0010294653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Date Device Manufactured: 06/30/2020
• 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; Required Intervention
• Patient Age: 63 YR