Amplatzer™ 9-ASD-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067019257), received between Mar 24, 2020 and Apr 18, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT IN THE LEFT ATRIUM, THE DEVICE HAD A COBRA DEFORMATION AND THE HEALTH CARE PROFESSIONAL TRIED SEVERAL ATTEMPTS TO CORRECT THE DEVICE, BUT WAS UNSUCCESSFUL. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND ANGIOGRAPHY IMAGES WERE CHECKED BUT IT WAS SEEN THAT THE DEVICE CONTINUED TO NOT DEPLOY NORMALLY. THERE WAS NO REPORT OF ANY INTERACTION WITH LUMEN TISSUE DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT ALSO DID NOT DEPLOY NORMALLY. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 17MM AMPLATZER SEPTAL OCCLUDER WITH SAME DELIVERY SYSTEM AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763786 ↗
• MalfunctionMar 31, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 17MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT DEVICE WAS IMPLANTED IN THE PATIENT WITH NO ADVERSE CONSEQUENCES. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEMS. IT WAS ALSO REPORTED THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653331 ↗
• MalfunctionJun 3, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 17MM AMPLATZER SEPTAL OCCLUDER HAD BEEN CHOSEN FOR PROCEDURE ON (B)(6) 2022 USING AN 8 F DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE PRESENTED WITH A DEFORMATION. IT WAS NOTED THAT THE DEVICE WAS RE-SHEATHED FIVE TIMES, THE DEVICE WAS RETRIEVED. THE DEVICE ATTEMPTED AGAIN BUT THE DEFORMATION PERSISTED. IT WAS NOTED THAT THERE WAS A DELAY IN PROCEDURE BUT THAT THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE DEVICE WAS REMOVED AND EXCHANGED WITH A NEW 17MM AMPLATZER SEPTAL OCCLUDER, THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS NOTED HAVE BEEN DISCHARGED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598670 ↗
• MalfunctionApr 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2022, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, THE LEFT DISC APPEARED OVAL AND WAS PROTRUDING INTO THE LEFT ATRIUM. IT WAS NOTED THAT TWO ATTEMPTS WERE MADE TO DEPLOY THE OCCLUDER BEFORE THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 17MM AMPLATZER SEPTAL OCCLUDER. THE NEW DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111083 ↗
• MalfunctionMar 24, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 DECIDED TO ATTEMPT A DEVICE IMPLANT OF 9-ASD-017. THE PHYSICIAN UNSHEATHED THE LEFT DISC DURING THE PROCEDURE AND THE DISC APPEARED COBRA SHAPED ON THE IMAGING MODALITIES. THE PHYSICIAN THEN DECIDED TO REMOVE THE DEVICE FROM THE PATIENTS BODY AND DID NOT WANT TO PROCEED WITH THE PROCEDURE USING THE MISSHAPED DEVICE. HE RE-SHEATHED THE LEFT DISC AND REMOVED THE DEVICE FROM THE PATIENTS BODY. THE PHYSICIAN THEN DEPLOYED A 9-ASD-018 SAFELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874367 ↗