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

Model Number D-EVPROP2329US

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve was too deep, therefore a se cond transcatheter bioprosthetic valve was implanted, valve in valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Other relevant device(s) are: product id: evproplus-29us, serial/lot #: (b)(4).Product analysis: the valve remains implanted and the delivery catheter system (dcs) was discarded.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.

• Brand Name: EVOLUT PRO PLUS DCS
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13669023
• MDR Text Key: 286588989
• Report Number: 2025587-2022-00599
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010907720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Date Device Manufactured: 10/22/2021
• 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): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female