Amplatzer™ Post Infarct Muscular VSD Occluder (REF 9-VSDMPIHDE-020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067028129), received between Jan 17, 2019 and Jun 19, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 20MM AMPLATZER POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS UTILIZED WITH A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. UPON DEPLOYMENT, THE LEFT DISC DEFORMED IN A COBRA SHAPE. THE DEVICE WAS RECAPTURED AND RE-DEPLOYED TWICE AND THEN THE LEFT DISC RE-FORMED TO ITS EXPECTED SHAPE. THE REST OF THE DEVICE WAS DEPLOYED FROM THE DELIVERY SYSTEM, AND THE RIGHT DISC WAS ELONGATED, COMPRESSED, AND DEFORMED. THE RIGHT VENTRICULAR DISC MAY HAVE BEEN CONSTRAINED WITHIN RIGHT VENTRICULAR TRABECULATION. IN ATTEMPTING TO RECAPTURE THE RIGHT DISK THE DEVICE SLIPPED THROUGH THE DEFECT INTO THE RIGHT VENTRICLE. THE DEVICE WAS REMOVED AND A REPLACEMENT 22MM AMPLATZER POST-INFARCT VSD OCCLUDER. THE PATIENT HAD SEVERAL RUNS OF VENTRICULAR TACHYCARDIA REQUIRING PACING DURING THE PROCEDURE. THEY ALL RESOLVED QUICKLY AND DID NOT PROLONG THE PROCEDURE AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. THERE WAS NO REPORT ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Tachycardia

  MAUDE report 17159829 ↗
• InjuryJan 17, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 20MM AMPLATZER PI MUSCULAR VSD OCCLUDER WAS IMPLANTED. AFTER THE PROCEDURE, THE DEVICE EMBOLIZED AND WAS SNARED AND EXPLANTED ON THE SAME DAY. PER REPORT, THE PATIENT'S DEFECT WAS TOO LARGE FOR OCCLUSION SO THE PROCEDURE WAS ABORTED. THE USER ATTRIBUTES PATIENT ANATOMY TO THE CAUSE OF EMBOLIZATION. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255809 ↗