MAUDE Adverse Event Report: SORIN GROUP MITROFLOW AORTIC PERICARDIAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Obstruction of Flow (2423); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Aortic Valve Stenosis (1717); Hematoma (1884); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that a 23 mm transcatheter bioprosthetic valve was implanted due to a failed 23 mm sorin mitroflow aortic valve approximately eight years and ten months post - implant.The failure mechanism of the sorin was aortic regurgitation and aortic stenosis.During the second valve implant procedure, it was reported that the abbott vascular prostar closure device failed and resulted in a right iliac artery hematoma.Subsequently, a covered stent was implanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW AORTIC PERICARDIAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP
• MDR Report Key: 17532625
• MDR Text Key: 321140018
• Report Number: MW5139532
• 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: 07/28/2016

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
• Treatment: ABBOTT VASCULAR PROSTAR XL.