Amplatzer™ 9-ASD-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067019219), received between May 25, 2022 and Mar 3, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 13MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN 8FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT IN THE LEFT ATRIUM, THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 13MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT DEVICE WAS IMPLANTED IN THE PATIENT AND THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478667 ↗
• MalfunctionJan 9, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 13MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE VIA FLUOROSCOPY, THAT THE OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE OCCLUDER WAS NOT DAMAGED OR MISHANDLED DURING DEVICE PREPARATION. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 13MM AMPLATZER SEPTAL OCCLUDER WITH A 15MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE. THE 13MM AMPLATZER SEPTAL OCCLUDER HAD BEEN REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126224 ↗
• InjuryMay 26, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, ¿TREATMENT EXPERIENCE OF PERCUTANEOUS EMBOLIZATION USING MULTIPLE-CLOSURE EMBOLIZATION FOR POROUS ATRIAL SEPTAL DEFECT (MASD)¿, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A BACKGROUND OF PERCUTANEOUS EMBOLIZATION FOR POROUS ATRIAL SEPTAL DEFECT (MASD), THE NUMBER OF OBTURATOR PLUGS, CLOSING PLUGS SELECTION, AND THE PLACEMENT PROCEDURES TREATMENT REQUIRED FOR EACH INDIVIDUAL. THE PURPOSE IS TO REPORT MASD TREATMENT EXPERIENCE USING MULTIPLE-CLOSURE PLUGS IN OUR HOSPITAL AND TO INVESTIGATE THE FACTORS THAT INFLUENCED CLOSURE PLUG SELECTION. CASES WERE REVIEWED RETROSPECTIVELY TO INVESTIGATE THE NUMBER OF DEFECT HOLES, SIZE, DISTANCE BETWEEN HOLES, INDWELLING CLOSURE PLUG, RELATIONSHIP WITH SURROUNDING STRUCTURES, AND PRESENCE OF RESIDUAL SHUNT. [CASE 1]. A (B)(6) GIRL. INTERFORAMINAL DISTANCE 6MM, ACCESSORY FORAMEN 6MM ANTERIOR TO THE MAIN FORAMEN 13MM. A AMPLATZER SEPTAL OCCLUDER (ASO) 6MM WAS PLACED IN THE ACCESSORY FORAMEN, AND A ASO 13MM WAS PLACED IN THE MAIN FORAMEN, BUT ASO 13MM WAS DISLODGED AT THE TIME OF DETACH. THE CLOSING PLUG OF THE MAIN FORAMEN WAS CHANGED TO 15MM, AND INTERFERENCE WITH THE SURROUNDING TISSUES WAS CARRIED OUT WITHOUT RESIDUAL SHUNT. IN SUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14504281 ↗
• MalfunctionMay 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED, A 13 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6)2022. DURING THE PROCEDURE, PRIOR TO RELEASE OF THE OCCLUDER, THE OCCLUDER PRESENTED WITH A COBRA SHAPED DEFORMATION AFTER BEING RE-SHEATHED TWO TIMES. THE DEVICE WAS REMOVED AND BOTH THE 13MM AMPLATZER SEPTAL OCCLUDER AND THE 9F AMPLATZER TREVISO INTRAVASCULAR DELIVERY SYSTEM WERE EXCHANGED WITH A NEW 13 MM AMPLATZER SEPTAL OCCLUDER AND NEW DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14494133 ↗