MAUDE Adverse Event Report: UNKNOWN E2 HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, the patient was noted with bleeding (oozing) from the right groin.The patient was treated with medication resolving the condition.Additional information was received that hypertension was noted the day of implant, related to the procedure.The issue was resolved with medications.No other adverse patient effects were reported.Additional information was received that this core valve was implanted valve-in-valve into a failed biocor surgical aortic valve (sa v) that had been implanted approximately 7.5 years.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: E2 HEART-VALVE, NON-ALLOGRAFT TISSUE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525837
• MDR Text Key: 321066919
• Report Number: MW5132778
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1