Amplatzer™ 9-VSD-MUSC-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811806011851), received between Dec 18, 2018 and Nov 12, 2024 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 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 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT. DURING DEVICE DEPLOYMENT, THE DEVICE TOUCHED THE ATRIOVENTRICULAR (AV) CONNECTION AREA, CAUSING A COMPLETE HEART BLOCK. THE PATIENT HAD A COURSE OF ASYSTOLE AND WAS PROVIDED WITH A TEMPORARY PACEMAKER. UNDERLYING RHYTHM RETURNED. THE DEVICE WAS IMPLANTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Cardiac Arrest; Heart Block

  MAUDE report 20667647 ↗
• InjuryApr 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. THE AMPULLA WAS MEASURED AT 18.8MM. THE TIGHTEST RESTRICTION OF THE DUCT WAS 12X16.6MM. THE PULMONARY ARTERY OPENING WAS 18MM AND THE LENGTH WAS 22.5MM. ANGIOGRAPHY WAS USED TO DETERMINE SIZING. FLUOROSCOPY AND ECHOCARDIOGRAM WAS USED FOR THE PROCEDURE. DURING THE PROCEDURE THE DEVICE WAS PLACED ON THE PATENT DUCTUS ARTERIOSUS (PDA) AND IT WAS DETERMINED THAT THE SIZE OF THE DEVICE WAS TOO SMALL. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH AN 18MM AMPLATZER MUSCULAR VSD OCCLUDER. THE DEVICE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. SEVERAL HOURS POST-IMPLANT THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE RIGHT PULMONARY ARTERY AND CAUSED A PARTIAL BLOCKAGE. THE DEVICE WAS SNARED WITH A TRANSCATHETER SNARE AND REMOVED FROM THE PATIENT. AN 18MM AMPLATZER POST-INFARCT VSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS DETERMINED TO BE TOO SMALL. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 22MM AMPLATZER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013109 ↗
• MalfunctionOct 5, 2023Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV) TO TREAT A PATIENTS MITRAL PARAVALVULAR LEAK (PVL). THE PATIENT CONDITION WAS NOT STABLE DUE TO CARDIOGENIC SHOCK. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THERE WAS NO KINK NOTICED ON THE DELIVERY SYSTEM BUT THERE WAS ANGULATION ON THE DELIVERY SYSTEM DUE TO ANGLE OF APPROACH. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 16MM AMPLATZER MUSCULAR VSD OCCLUDER AND 8F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV) WAS SELECTED, IT HAD THE SAME DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO KINK NOTICED ON THE DELIVERY SYSTEM BUT THERE WAS ANGULATION ON THE DELIVERY SYSTEM DUE TO ANGLE OF APPROACH. A NEW 14MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING A AMPLATZER TORQVUE DELIVERY SYSTEM. THE 14MM DEVICE DIDN'T RESOLVE THE PATIENTS PVL. THE PATIENT WAS NOT HEMODYNAMICALLY STABLE DURING AND AFTER THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS PASSED AWAY DUE TO SEPSIS. THE PATIENT HAD M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880340 ↗
• InjuryAug 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SUCCESSFULLY IMPLANTED ON THE VENTRICULAR SEPTAL DEFECT, USING 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEFECT WAS MEASURED TO BE 14MM. ONE-HOUR POST-IMPLANTATION, THE DEVICE EMBOLIZED IN THE VENA CAVA. IN THE PHYSICIAN¿S OPINION, IT IS SUSPECTED THAT THE TISSUE AROUND THE DEFECT WAS TOO SOFT FOR A GOOD STABILIZATION OF THE DEVICE, WHICH MIGHT HAVE CAUSED THE EMBOLIZATION. THE DEVICE WAS RECAPTURED VIA A TRANSCATHETER PROCEDURE. A REPLACEMENT DEVICE 18MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550739 ↗
• MalfunctionJul 11, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS CHOSEN FOR A VENTRICULAR SEPTAL DEFECT (VSD) PROCEDURE USING AN UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS DEFORMED AND NOT UNIFORM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE DOCTOR CANCELLED THE PROCEDURE. THERE WAS NO REPORTED ADVERSE CONSEQUENCES. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302130 ↗
• InjuryAug 17, 2022Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2022, A 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED USING AN ABBOTT DELIVERY SYSTEM. DUE TO THE PATIENT'S HISTORY OF TETRALOGY OF FALLOT, THE DEVICE WAS CHOSEN TO IMPLANT TO DECREASE AORTIC INSUFFICIENCY. THE DEVICE WAS SIZED USING ECHOCARDIOGRAPHY. DURING PROCEDURE, THE DEVICE EMBOLIZED WHEN THE DEVICE WAS ERRONEOUSLY DISLODGED FROM THE IMPLANT SITE BY A BALLOON. THE DEVICE TRAVELED TO THE PATIENT'S LEFT VENTRICLE. THE PATIENT WAS SENT TO EMERGENCY SURGERY TO RETRIEVE THE EMBOLIZED DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242627 ↗
• MalfunctionOct 12, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, AN 18MM AMPLATZER MUSCULAR VSD WAS SELECTED FOR IMPLANT. UPON DEPLOYMENT THE RIGHT ATRIAL DISK DID NOT REFORM TO ITS ORIGINAL SHAPE AND FORMED A COBRA SHAPE. IT WAS REMOVED, AND ANOTHER 18MM VSD DEVICE WAS SUCCESSFULLY DEPLOYED THROUGH THE SAME DELIVERY SYSTEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667602 ↗
• InjuryMar 24, 2020Inadequacy of Device Shape and/or Size; Biocompatibility; Inadequacy of Device Shape and/or Size; Biocompatibility

  ON (B)(6) 2020, THE PHYSICIAN ATTEMPTED TO CLOSE A VENTRICULAR SEPTAL DEFECT WITH A 9-VSD-MUSC-014 LOT # 6243914 BUT THE DEVICE PROLAPSED THROUGH THE DEFECT. IT WAS MIS-SIZED, NEVER RELEASED AND REMOVED FROM THE PATIENT¿S BODY. THE PHYSICIAN THEN DECIDED TO TRY A LARGER SIZE, A 9-VSD-MUSC-018 LOT # 6119716 BUT THIS DEVICE ALSO SLIPPED THROUGH THE DEFECT AND WAS MIS-SIZED. THE PHYSICIAN RE-SHEATHED THE 18MM DEVICE AND REMOVED IT FROM THE PATIENT. DURING THE PROCEDURE THE PATIENT BECAME UNSTABLE. THE PATIENT EXPERIENCED VTACH TWICE AND ALSO HAD TO BE TEMPORARILY PACED. THE PATIENT'S BLOOD PRESSURE DROPPED VERY LOW. THE PATIENT WAS SENT BACK TO ICU WHILE THE CARDIOLOGY TEAM DISCUSSED NEXT STEPS FOR THE PATIENT. THE PATIENT DIED DAYS LATER. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE PROCEDURE OR THE DEVICE. THE PATIENT WAS VERY ILL AND THE PHYSICIAN STATES THE CAUSE OF DEATH WAS DUE TO COMPLICATIONS OF A MYOCARDIAL INFARCTION.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 9875863 ↗
• InjuryFeb 27, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR USE. DURING DEVICE DEPLOYMENT, ONE OF THE DISCS DEPLOYED IN AN OVAL SHAPE. THE DEVICE WAS RE-DEPLOYED A SECOND TIME BUT THE ISSUE REMAINED. THE DEVICE WAS RETRIEVED, EXCHANGED FOR A 16 VSD OCCLUDER AND SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8376584 ↗
• InjuryDec 18, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, AN 18MM AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED. AFTER IMPLANT, THE PATIENT PRESENTED WITH HEMOLYSIS, WORSENING RENAL FUNCTION, AND ANEMIA. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED, AND FOLLOWING EXPLANT, THE PATIENT'S HEMOLYSIS RESOLVED. THE PATIENT IS REPORTED TO BE STABLE. THE PHYSICIAN SUSPECTED THE EVENT WAS DUE TO THE IMPLANTED DEVICE AS THE HEMOLYSIS WAS CLINICALLY APPARENT ROUGHLY 2 DAYS FOLLOWING OCCLUDER IMPLANT. THE ANEMIA WAS A MARKER OF HEMOLYTIC ACTIVITY PROGRESSION UNTIL EXPLANT OF DEVICE. AFTER THE DEVICE WAS EXPLANTED, THE PATIENT STABILIZED AND INDICATORS OF HEMOLYSIS RESOLVED. THE PATIENT DID NOT A HISTORY OF HEMOLYSIS, RENAL FAILURE OR ANEMIA AND BASELINE PARAMETERS AT ADMISSION WERE NORMAL.

  Patient problems: Hemolysis; Hemolytic Anemia; Renal Failure

  MAUDE report 8177070 ↗