Amplatzer™ Post Infarct Muscular VSD Occluder (REF 9-VSDMPIHDE-024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067028143), received between Mar 12, 2019 and Dec 9, 2025 — classified as 4 deaths, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS IMPLANTED IN THE PATIENT. THE OCCLUDER WAS IMPLANTED. ON AN UNKNOWN DATE, IT WAS NOTED THAT THE DEVICE IS LOCATED IN THE DEFECT BUT HAS SHIFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760596 ↗
• DeathJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER. IT WAS NOTED DURING THE PROCEDURE THAT THE PATIENT DEVELOPED A CARDIAC EFFUSION. THE DECISION WAS MADE TO REMOVED THE OCCLUDER FROM THE PATIENT'S BODY WITHOUT DISCONNECTING FROM THE DELIVERY CABLE. THE PATIENT PASSED AWAY ON AN UNKNOWN DATE DUE TO AN UNKNOWN REASON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 22510208 ↗
• InjuryOct 18, 2024Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN TO CLOSE A POST MYOCARDIAL INFARCTION (MI) VENTRICULAR SEPTAL DEFECT (VSD) PSEUDOANEURYSM UTILIZING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. HEPARIN WAS ADMINISTERED, AND PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE GREATER THAN 250 SECONDS. DURING THE PROCEDURE, FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE USED. THE DEVICE WAS DEPLOYED ONCE, AND THE DEVICE PULLED THROUGH THE DEFECT FROM THE LEFT VENTRICLE TO THE RIGHT VENTRICLE, POSSIBLY CAUSING A LARGER HOLE. THERE WERE MULTIPLE WIRE EXCHANGES. THE DEVICE WAS REMOVED FROM THE PATIENT. INTRAPROCEDURAL PRIOR TO LEAVING THE CATH LAB, A CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS NOTED NEAR THE RIGHT VENTRICLE AND LEFT VENTRICLE. A PERICARDIOCENTESIS WAS REQUIRED. THE PATIENT RECEIVED 4 UNITS OF BLOOD DUE TO PROCEDURAL COMPLICATION AND PATIENT'S COMORBIDITIES. THE PHYSICIAN BELIEVED THAT THE PERICARDIAL EFFUSION WAS A COMPLICATION FROM THE PROCEDURE. THE PATIENT WAS EXTUBATED AND REINTUBATED DUE TO RESPIRATORY DISTRESS. THE PATIENT WAS TRANSITIONED TO HOSPICE AND COMFORT CARE. ON (B)(6) 2024, THE PATIENT LAT

  Patient problems: Pericardial Effusion; Respiratory Insufficiency

  MAUDE report 20485966 ↗
• DeathJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT TO CLOSE A POST-INFARCT VENTRICULAR SEPTAL DEFECT WITH AN INFERIOR WALL PSEUDOANEURYSM. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED TO CLOSE THE DEFECT. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. POST PROCEDURE, THE PATIENT EXPERIENCED CARDIAC TAMPONADE, HYPOXIA, AND CARDIAC ARREST. THE PATIENT DIED ON (B)(6) 2024.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Hypoxia; Insufficient Information; Pericardial Effusion

  MAUDE report 19732802 ↗
• InjuryApr 5, 2023Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Device Damaged by Another Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6), 2023, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS IMPLANTED USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. ON (B)(6), 2023, THE DEVICE EMBOLIZED INTO THE RIGHT VENTRICLE. ON AND UNKNOWN DATE, THE DEVICE WAS SNARED AND MOVED INTO THE LEFT VENTRICLE. IT WAS NOTED THAT THERE WAS A LARGE AMOUNT OF RESISTANCE MOVING THE DEVICE WITH THE SNARE. UPON INSPECTION OF THE DEVICE, IT WAS NOTED THAT THE DEVICE HAD DEFORMED INTO A COBRA SHAPE. IT IS THOUGHT THAT THE DEVICE WAS CAUGHT IN THE TRICUSPID CORDS, SO WHEN THE OCCLUDER WAS DEPLOYED THE RIGHT DISK DIDN'T FORM CORRECTLY OR ELONGATE. THE PATIENT IS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685488 ↗
• MalfunctionJan 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED A 24 MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN FOR PROCEDURE, DURING PROCEDURE, THE DEVICE WAS POSITIONED IN NORMAL FASHION. PRIOR TO RELEASE THE DEVICE PRESENTED IN A COBRA SHAPE WHILE IN THE RIGHT VENTRICLE. THE DEVICE WAS ALSO DETERMINED TOO BIG VIA IMAGING AND THE DEVICE WAS REMOVED. A SMALLER, 18MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN. THE DEVICE WAS DETERMINED A FIT AND THE DEVICE WAS RELEASED FOR PLACEMENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND HAS BEEN DISCHARGED HOME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285439 ↗
• DeathDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT WITH A PAST MEDICAL HISTORY OF SEVERELY REDUCED RIGHT AND LEFT VENTRICULAR FUNCTION, CARDIOGENIC SHOCK, MULTI-ORGAN FAILURE, AND MORBID OBESITY. DURING PROCEDURE, THE LEFT VENTRICULAR DISK WAS DEPLOYED IN THE LEFT VENTRICLE, FOLLOWED BY THE RIGHT VENTRICULAR DISK IN THE RIGHT VENTRICLE, HOWEVER, THE DEVICE SLIPPED INTO THE RIGHT VENTRICLE PRIOR TO BEING RELEASED FROM THE CABLE. SHORTLY AFTER, THE PATIENT BECAME HYPOTENSIVE, RESULTING IN HEMODYNAMIC INSTABILITY AND THE PATIENT PASSED AWAY, PRESUMED TO BE FROM A VENTRICULAR RUPTURE. THE USER ALLEGED THAT THE PATIENT'S PASSING WAS DUE TO THE PROCEDURE AND THE PATIENT'S COMORBIDITIES.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 13056568 ↗
• MalfunctionFeb 9, 2021Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  ON (B)(6) 2021, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE THE DEVICE WAS DEFORMED AFTER PLACING THE DEVICE INTO THE POST MI DEFECT. THE PHYSICIAN DEPLOYED, RECAPTURED AND REPOSITIONED THE DEVICE TWICE, BUT STILL DID NOT LIKE THE POSITION. THE PHYSICIAN RETRACTED THE DEVICE, CLEANED IT AND RELOADED THE DEVICE INTO THE DELIVERY SYSTEM, BUT THE DEVICE WAS NOT SALVAGEABLE. THE VENTRICULAR DISC WAS COBRA SHAPED AND THE WAIST WAS MANGLED TO THE POINT WHERE THE DEVICE COULD NOT GO BACK TO ITS ORIGINAL SHAPE. THE DEVICE WAS EXCHANGED FOR A 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER AND SUCCESSFULLY IMPLANTED WITHOUT INCIDENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305171 ↗
• DeathNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE ATTEMPTING A POST MI VSD PROCEDURE ON AN (B)(6) YEAR OLD WOMAN WITH A RECENT TRAUMATIC VENTRICULAR SEPTAL RUPTURE DUE TO A MYOCARDIAL INFARCTION, A WIRE AND AN 11F COOK SHEATH WERE PLACED ACROSS THE DEFECT FROM THE VENOUS SIDE INTO THE LV. UPON PREPPING THE AMPLATZER 24MM PMIVSD DEVICE IT WAS NOTICED ON TEE THAT THE PATIENT WAS DEVELOPING A PERICARDIAL EFFUSION. IT WAS DECIDED TO FIRST DEPLOY DEVICE THEN DEAL WITH THE EFFUSION. THE DEVICE WAS DELIVERED AND DEPLOYED. THE PHYSICIAN THEN PROCEEDED TO PREP FOR THE PERICARDIAL DRAIN. THE PERICARDIAL SPACE WAS DRAINED AND THE PATIENT WAS BEING MONITORED. DESPITE THE EFFORTS OF THE TEAM THE PATIENT DIED IN THE ROOM.

  Patient problems: Death; Myocardial Infarction; Pericardial Effusion

  MAUDE report 10832605 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, GIVEN ALL OF THE MEASUREMENTS FROM THE ECHO AND CT STUDIES A 24MM PIVSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 10FR TREVISIO DELIVERY SYSTEM IN A (B)(6) YEAR OLD PATIENT WITH A POST INFARCT VSD. AFTER PLACING THE DEVICE, THE RIGHT VENTRICULAR DISC APPEARED TO BE CONSTRAINED IN AN UNUSUAL CONFIGURATION BY SOME TRABECULATIONS. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE AND REPOSITION THE DEVICE, BUT THE RIGHT VENTRICULAR DISC WAS UNABLE TO GET IN A GOOD POSITION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DEVICE WAS DISTORTED AND COULD NOT BE RE-SHAPED. A NEW 24 MM PIVSD OCCLUDER WAS SELECTED FOR IMPLANT. ONCE PLACED IN THE SEPTUM, THE DEVICE YIELDED THE SAME ELONGATED AND CONSTRAINED CONFIGURATION AS THE PREVIOUS DEVICE. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD A LONG SERPIGINOUS TRACT AND DECIDED TO USE A 35MM AMPLATZER CRIBRIFORM OCCLUDER. THE 35MM DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. FOLLOW-UP ECHO AFTER THE PROCEDURE SHOWED THAT THE DEVICE WAS IN GOOD POSITION. THE PATIENT IS RECOVERING. REFERENCE MANUFACTU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9970118 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, GIVEN ALL OF THE MEASUREMENTS FROM THE ECHO AND CT STUDIES A 24MM PIVSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 10FR TREVISIO DELIVERY SYSTEM IN A (B)(6) YEAR OLD PATIENT WITH A POST INFARCT VSD. AFTER PLACING THE DEVICE, THE RIGHT VENTRICULAR DISC APPEARED TO BE CONSTRAINED IN AN UNUSUAL CONFIGURATION BY SOME TRABECULATIONS. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE AND REPOSITION THE DEVICE, BUT THE RIGHT VENTRICULAR DISC WAS UNABLE TO GET IN A GOOD POSITION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DEVICE WAS DISTORTED AND COULD NOT BE RE-SHAPED. A NEW 24 MM PIVSD OCCLUDER WAS SELECTED FOR IMPLANT. ONCE PLACED IN THE SEPTUM, THE DEVICE YIELDED THE SAME ELONGATED AND CONSTRAINED CONFIGURATION AS THE PREVIOUS DEVICE. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD A LONG SERPIGINOUS TRACT AND DECIDED TO USE A 35MM AMPLATZER CRIBRIFORM OCCLUDER. THE 35MM DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. FOLLOW-UP ECHO AFTER THE PROCEDURE SHOWED THAT THE DEVICE WAS IN GOOD POSITION. THE PATIENT IS RECOVERING. REFERENCE MANUFACTU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9970114 ↗
• InjuryMar 31, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, A 24MM AMPLATZER POST INFARCT VSD OCCLUDER IN A THREE DAY OLD MYOCARDIAL INFARCTION. THE DEVICE WAS MIS-SIZED TOO SMALL AND PULLED THROUGH. THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION. THE DEFECT IS PLANNED TO BE SURGICALLY FIXED WHEN A BYPASS SURGERY IS PERFORMED ON THE PATIENT.

  Patient problems: Heart Failure; Myocardial Infarction

  MAUDE report 9908757 ↗
• InjuryMar 12, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 24MM AMPLATZER PI MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT TO CLOSE A POST INFARCT VSD. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND AFTER 2 UNSUCCESSFUL ATTEMPTS TO DEPLOY THE DEVICE, AS THE RIGHT DISC DID NOT DEPLOY AS ANTICIPATED; THE USER ELECTED TO ABANDON THE PROCEDURE. THE USER REPORTS THE DEFORMATION WAS ASSOCIATED WITH THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION IS ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411901 ↗