Amplatzer™ Post Infarct Muscular VSD Occluder (REF 9-VSDMPIHDE-022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067028136), received between Feb 16, 2023 and Feb 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE PHYSICIAN DECIDED THE DEVICE DUE TO MASSIVE MITRAL PVL UNABLE TO CLOSE WITH TWO AVP II 20MM DEVICES. THE PHYSICIAN USED THE LARGEST VSD OCCLUDER IN CONJUNCTION WITH A 20MM AVP II DEVICE. THIS COMBINATION OF DEVICES WAS THE ONLY COMBINATION IN THIS COMPLEX PARAVALVULAR LEAK TO SHOW SIGNIFICANT REDUCTION IN PVL FOR THIS PATIENT WHO WAS IN ACUTE HEART FAILURE. POST PROCEDURE, THE PATIENT HAD HEMATURIA WITH LAB ABNORMALITIES CONSISTENT WITH HEMOLYSIS FROM IMPLANTED DEVICES. THE PATIENT RECEIVE BLOOD TRANSFUSIONS TO ADDRESS THE HEMOLYSIS. ON (B)(6) 2022, THE PATIENT HAD SURGICAL RE-OPERATION TO REMOVE THE DEVICE AND TO REPAIR THE MITRAL PARAVALVULAR LEAK. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED TO A LONG-TERM ACUTE CARE HOSPITAL.

  Patient problems: Hemolytic Anemia

  MAUDE report 16389926 ↗