MAUDE Adverse Event Report: MEDTRONIC / MEDTRONIC HEART VALVES DIVISION 34MM EVOLUT MEDTRONIC; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVPROPLUS-34US

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Anemia (1706); Failure of Implant (1924); Obstruction/Occlusion (2422)

Event Date 05/24/2022

Event Type  Death  

Event Description

Tavr was complicated by the medtronic prosthetic valve inverting causing occlusion.Hgb dropped from 11.3 to 3.2.Fda safety report id # (b)(4).

Event Description

Additional information received from reporter for report mw511620 correction of age.

• Brand Name: 34MM EVOLUT MEDTRONIC
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC / MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 14874758
• MDR Text Key: 295130682
• Report Number: MW5110620
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: D665870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic