Amplatzer™ 9-PDA2-06-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00811806011257), received between Apr 15, 2019 and Jul 9, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 5F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT, THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS SOME INTERACTION BETWEEN THE DEVICE AND CARDIAC STRUCTURES. THERE WERE NO ANGULATION OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE PROCEDURE WAS POSTPONED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705802 ↗
• MalfunctionJan 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 5F AMPLATZER TORQVUE LP. DURING THE PROCEDURE THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REPLACED WITH A NEW AMPLATZER VASCULAR PLUG II. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE PATIENT STATUS WAS STABLE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18497922 ↗
• InjuryJun 26, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT, USING 05F AMPLATZER TORQVUE LP DELIVERY SYSTEM. THE DEFECT WAS MEASURED TO BE 7MM IN LENGTH, NARROWEST 4.5MM, AND AMPULLA 6MM. AFTER RELEASE OF THE OCCLUDER FROM THE DELIVERY CABLE, THE PULMONARY ARTERY (PA) SIDE DISC HAD SHIFTED WITHIN THE INTENDED IMPLANT SITE, AND THE LEFT PULMONARY ARTERY (LPA) BECAME PARTIALLY OBSTRUCTED. THE DEVICE WAS SNARED EASILY. A REPLACEMENT 8-6MM AMPLATZER DUCT OCCLUDER WAS USED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17204191 ↗
• InjuryMay 16, 2023Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) - PARADIGM, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 02 FEBRUARY 2023, AN 8X4MM AMPLATZER VALVULAR PLUG AND A 6MMX4MM AMPLATZER DUCT OCCLUDER II WERE SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA FOR PROCEDURE. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT PROCEDURE. THE PLUG AND OCCLUDER WERE IMPLANTED FOR THE CLOSURE OF A CARDIAC PARAVALVULAR LEAK (PVL). THE PLUG AND OCCLUDER WERE BOTH SIZED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY MEASUREMENTS. ON (B)(6) 2023, THE PATIENT WAS RE-ADMITTED DUE TO THE PATIENT'S REPORTING CONSISTENTLY DARK URINE AND A SMALL STREAK OF BLOOD EVERY TIME DURING URINATION (HEMATURIA). A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A SEVERE RESIDUAL SHUNT ANTEROLATERAL TO THE 8X4MM AMPLATZER VALVULAR PLUG AND POSTEROMEDIAL TO THE 6MMX4MM AMPLATZER DUCT OCCLUDER II. ON (B)(6) 2023, AN X-RAY WAS PERFORMED AND REVEALED INCREASED RIGHT AND LEFT KIDNEY ECHOGENICITY, A MILDLY DISTENDED BLADDER WITH MILD CIRCUMFERENTIAL BLADDER WALL THICKENING, AND A ANECHOIC CYSTIC STRUCTURE POSTEROLATERAL TO THE URINARY BLADDER. ON (B)(6) 2023, A COMPUTED TOMOGRAPHY

  Patient problems: Renal Failure

  MAUDE report 16943206 ↗
• MalfunctionMar 7, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6-4MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN FOR IMPLANT WITH A 6FR NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT, THE OPERATOR NOTICED THE DEVICE HAD A COBRA DEFORMATION AND WAS "NOT TAKING THE DESIRED SHAPE." A DECISION WAS MADE TO RETRACT THE DEVICE AND ABORT THE PROCEDURE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE, THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO REPORT OF ANY ANGULATION/KINK WITH THE DELIVERY SYSTEM. THERE WAS NO REPORT OF A REPLACEMENT DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497509 ↗
• InjuryMar 2, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE "STRUCTURE CLUB JAPAN LIVE DEMONSTRATION 2022 (P.59)" WAS REVIEWED IT WAS REPORTED THAT ON MARCH OF AN UNKNOWN YEAR, A PATIENT HAD AN UNKNOWN MECHANICAL HEART VALVE IMPLANTED. IN NOVEMBER OF THE SAME YEAR, A PARAVALVULAR LEAK WAS FOUND, AND THE VALVE WAS REPLACED WITH ANOTHER UNKNOWN VALVE. IN MARCH OF A DIFFERENT UNKNOWN YEAR, THE PATIENTS CARDIAC INSUFFICIENCY EXACERBATED, AND THE PARAVALVULAR LEAK WAS OBSERVED AGAIN. IT WAS DEICED TO ATTEMPT PERCUTANEOUS PARAVALVULAR LEAK CLOSURE. THERE WERE 3 PARAVALVULAR LEAKS BETWEEN 6 O'CLOCK AND 9 O'CLOCK. IT WAS ALSO NOTED THAT THE ANNULUS WAS FLAILED PARTIALLY. A 4MM X 4MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED AT THE 9 O'CLOCK POSITION. THEN A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED IN THE 6 O'CLOCK, AND THE PARAVALVULAR LEAK WAS UNABLE TO BE CONTROLLED DUE TO THE FLAILED ANNULUS. THE 6MM X 4MM AMPLATZER DUCT OCCLUDER II THEN FELL OUT OF ITS ORIGINAL POSITION. A 16MM AMPLATZER VASCULAR PLUG II WAS THE IMPLANTED INTO THE 6 O'CLOCK POSITION. A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS THEN IMPLANTED AT THE 8 O'CLOCK POSITION TO COMPLETE THE PROCEDURE. 7 DAYS POST OPERATIVELY THE 16MM AMPLATZER VASCULAR PLUG II EMBOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474304 ↗
• MalfunctionFeb 7, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM BY 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SHEATH. WHILE ATTEMPTING TO DEPLOY THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS DEFORMED IN A COBRA LIKE SHAPE. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONCLUDED WITHOUT IMPLANTING A REPLACEMENT DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313902 ↗
• MalfunctionAug 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6MM BY 4MM AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANTATION USING A 5F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FORMING A COBRA DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES, AND NO KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A 6MM BY 6MM AMPLATZER DUCT OCCLUDER II, WHICH WAS SUCCESSFULLY IMPLANTED. 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 15220156 ↗
• MalfunctionJul 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6MM X 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR PROCEDURE. DURING IMPLANT, IT WAS NOTED THAT THE DEVICE WAS NOT TAKING THE PROPER SHAPE. THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURE DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. IT WAS NOTED THAT THE DEVICE WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15031436 ↗
• MalfunctionJul 11, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AX AMPLATZERADOII 6MM DIA 4MM WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT, DEVICE WAS NOT TAKING PROPER SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NEW AMPLATZER ADOII 6MM DIA 6MM WAS SELECTED AND IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982618 ↗
• MalfunctionMar 12, 2020Expulsion; Expulsion

  ON (B)(6) 2020, AN AMPLATZER DUCT OCCLUDER II WAS SELECTED FOR IMPLANT. ON (B)(6) 2020, THE DEVICE EMBOLIZED INTO THE LEFT PULMONARY ARTERY. THE DEVICE WAS RETRIEVED, AND THE PATIENT UNDERWENT SURGERY TO CORRECT THE ISSUE. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823330 ↗
• InjuryOct 28, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, A 6/4MM AMPLATZER DUCT OCCLUDER II (ADOII) WAS SELECTED FOR IMPLANT. THE ADO II WAS DEPLOYED IN THE DEFECT AND NO LEAKAGE WAS OBSERVED. WHILE RELEASING THE DEVICE, THE AORTA SIDE OF THE DISC FELL OUT TOWARDS THE PULMONARY ARTERY. THE DEVICE WAS RETRIEVED USING A 15MM GOOSENECK SNARE CATHETER. A 10/8MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. THE PATIENT IS NOTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9247915 ↗
• InjuryApr 15, 2019Migration; Migration

  ON (B)(6) 2019, A 6/6MM AMPLATZER DUCT OCCLUDER II (ADOII/ 9-PDA2-06-06) WAS DEPLOYED IN THE PATENT DUCTUS ARTERIOSUS (PDA) WITH NO ISSUES NOTED. ON (B)(6) 2019, THE DEPLOYED ADOII WAS CONFIRMED TO BE MIGRATED TOWARD THE PULMONARY ARTERY SIDE. THE MIGRATED ADOII WAS RETRIEVED IMMEDIATELY AND PERCUTANEOUSLY BY USING A 25MM SNARE CATHETER WHICH WAS DELIVERED THROUGH AN 8F GUIDING CATHETER (TYPE: JR4). THE PATIENT WAS MONITORED IN STABLE CONDITION POSTOPERATIVELY. PER PHYSICIAN, THE ADOII MAY HAVE BEEN MIS-SIZED FOR THE PATIENT'S PDA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8513234 ↗