AMPLATZER™ 9-ITV08F180/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806010823), received between May 23, 2023 and Aug 6, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT A 14-12MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024, USING AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEFECT WAS MEASURED AS 7MM IN DIAMETER AND 9MM IN LENGTH VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE DEVICES WERE PREPARED PER IFU. ECHOCARDIOGRAM AND FLUOROSCOPY WERE USED DURING THE PROCEDURE. DURING IMPLANT, THE CABLE CONNECTION WAS CHECKED PRIOR TO DEPLOYMENT. WHILE DEPLOYING THE DEVICE, IT WAS OBSERVED THROUGH FLUOROSCOPY THAT THE DEVICE PREMATURELY DETACHED FROM THE DELIVERY CABLE. THE DEVICE EMBOLIZED INTO THE DESCENDING AORTA. THE DEVICE WAS SNARED VIA TRANSCATHETER SNARE AND REMOVED FROM THE PATIENT. A NEW 16-14MM AMPLATZER DUCT OCCLUDER AND 8F AMPLATZER TORQVUE DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924501 ↗
• MalfunctionMay 24, 2023Retraction Problem; Device Damaged by Another Device; Material Twisted/Bent; Retraction Problem; Device Damaged by Another Device; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6)2023, AN 8MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT VIA FEMORAL VEIN APPOACH WITH A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE 8MM DEVICE APPEARED TOO SMALL AND THE DEPLOYMENT ANGLE WAS NOT IDEAL SO THE 8MM DEVICE WAS REPLACED PRIOR TO RELEASE WHILE INSIDE THE PATIENT. A 10MM AMPLATZER MUSCULAR VSD OCCLUDER WAS THEN CHOSEN FOR IMPLANT WITH THE SAME 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE 10MM OCCLUDER ALSO APPEARED TOO SMALL AND THE DEPLOYMENT ANGLE WAS ALSO NOT IDEAL. A DECISION WAS MADE TO REPLACE BOTH THE 10MM OCCLUDER AND 6F DELIVERY SYSTEM. IT WAS THEN REPORTED A 12MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT VIA INTERNAL JUGULAR APPROACH WITH A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE 12MM OCCLUDER WAS NOT ABLE TO BE RELEASED FROM THE DELIVERY CABLE. BOTH 12MM OCCLUDER AND 7F DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND THE 12MM OCCLUDER WAS REMOVED FROM THE DELIVERY CABLE WITHOUT DIFFICULTY. A DECISION WAS MADE TO IMPLANT THE SAME 12MM OCCLUDER WITH AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, DUE TO THE DEPLOYMENT ANGLE NOT BEING IDEAL, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998318 ↗
• DeathMay 23, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16-14MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR PROCEDURE USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM FOR A PATIENT WITH A POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD). THE PATIENT HAD A MYOCARDIAL INFARCTION ON (B)(6) 2023. THE PHYSICIAN MADE THE DECISION TO CHOSE AN AMPLATZER DUCT OCCLUDER DUE TO THE VSD LOCALIZATION AT THE APEX OF THE HEART. HEPARIN WAS ADMINISTERED DURING PROCEDURE. THE OCCLUDER WAS UNABLE TO BE INTRODUCED INSIDE THE DELIVERY SYSTEM. THE DEVICE WAS BLOCKED AT THE ENTRANCE OF THE DELIVERY SYSTEM. AFTER A FEW ATTEMPTS, THE DECISION WAS MADE TO REPLACE THE DELIVERY SYSTEM WITH AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE MULTIPLE MANIPULATIONS TO FIND THE OPTIMAL POSITION OF THE OCCLUDER. THE OCCLUDER RECAPTURED ONCE BEFORE IT WAS IMPLANTED. A PERICARDIAL EFFUSION WAS NOTED AT THE APEX OF THE HEART. THE ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 360 SECONDS. A PERICARDIOCENTESIS WAS PERFORMED WITH A REDUCTION TO THE EFFUSION. HOWEVER, THE PERICARDIAL EFFUSION THEN DEVELOPED INTO CARDIAC TAMPONADE AND WAS UNABLE TO BE REVERSED. THE PATIENT DIED AT THE END OF THE PROCEDURE. THE PERICARDIAL EFFUSION WAS BELIEVED TO BE DUE TO

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 16989583 ↗