Amplatzer™ 9-PDA-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00811806011103), received between Aug 27, 2018 and Apr 17, 2026 — classified as 1 death, 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• DeathApr 17, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 20 MAR 2026, A 5-4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE IN A 2.5KG PATIENT. THE PDA MINIMAL DIAMETER WAS 4.2MM, PDA DIAMETER AT AORTIC AMPULLA WAS 5.5MM AND PDA LENGTH WAS 12MM. DURING PROCEDURE, A LARGE JET THROUGH AND AROUND DEVICE SHOWED THE DEVICE WAS NOT LARGE ENOUGH FOR THE DUCT. THE DUCT MEASURED 4.5 AT LARGEST AND 4.0 AND NARROWEST WITH 12MM LENGTH. THEY REMOVED THE PICCOLO OCCLUDER AND ATTEMPTED AN 8MM AMPLATZER VASCULAR PLUG II. BUT THE PLUG IMPEDED THE LEFT PULMONARY ARTERY (LPA), WAS NOT SAFE AND THEY REMOVED IT. A NEW 3MM AMPLATZER DUCT OCCLUDER WAS CHOSEN. THE DEVICE SAT GREAT, CLOSED THE DUCT AND DECIDED TO RELEASE THE DEVICE. THERE WAS 1-3MM LEAK WAS DETECTED AROUND THE LOBE OF THE DEVICE. A10-15 MIN LATER IT WAS NOTED THAT THE DEVICE WAS EMBOLIZED INTO PULMONARY ARTERY AND THEY SPENT THE NEXT TWO HOURS TRYING TO RETRIEVE THE DEVICE VIA PERCUTANEOUS RETRIEVAL BUT WAS UNSUCCESSFUL. THE CAUSE OF EMBOLIZATION/MIGRATION WAS UNSURE . DURING THAT TIME THEY BELIEVE A PERFORATION OCCURRED AND IT CAUSED THE PATIENT TO CODE. THEY TRIED TO REVIVE THE PATIENT FOR 40 MIN BUT WAS UNSUCCESSFUL. THE PATIENT WAS

  Patient problems: Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 24911826 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223728 ↗
• MalfunctionDec 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON- ABBOTT DEVICE. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE. THEREFORE THEY HAD TO RETRIEVE OUT OF THE PATIENT'S BODY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING A NON ABBOTT DEVICE. 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 23751131 ↗
• MalfunctionNov 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, 5-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS OBSERVED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF COBRA -LIKE DEFORMATION. THEREFORE, THE DEVICE WAS RETRIEVED OUT OF THE PATIENT'S BODY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. 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 23660782 ↗
• InjurySep 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  CLINICAL INFORMATION: (B)(6) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 5-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZE OF THE DEFECT WAS 3MM. THE SIZING WAS BASED ON A PRE-PROCEDURAL ECHOCARDIOGRAM. A PUSH AND PULL MANEUVER WAS PERFORMED BEFORE RELEASING THE DEVICE. THERE WAS 1-3 MM RESIDUAL SHUNT NOTED AROUND THE LOBE OF THE DEVICE. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, IT WAS NOTED THAT THE DEVICE WAS EMBOLIZED INTO MAIN PULMONARY ARTERY. DURING SURGICAL MANIPULATION THE DEVICE EMBOLIZED IN THE AORTA, WHERE IT WAS SURGICAL RETRIEVED ON (B)(6) 2025. THE PHYSICIAN BELIEVED THE CAUSE OF EMBOLIZATION WAS UNDER SIZING OF THE DEVICE DUE TO INACCURATE MEASUREMENT ON THE ECHOCARDIOGRAM. THE PATIENT WAS REPORTED DISCHARGED; FIRST POST DISCHARGE VISIT WAS COMPLETED WITH THE PATIENT IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084731 ↗
• MalfunctionAug 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, 5-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE WAS NOT TAKING DESIRED SHAPE AND THEY RETRIEVED THE DEVICE BACK. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE GOT ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898784 ↗
• InjuryMay 30, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5-4 MM AMPLATZER PDA OCCLUDER WAS IMPLANTED. FLUOROSCOPY WAS USED DURING IMPLANT. STABILITY CHECK WAS PERFORMED PRIOR TO RELEASE AND NO LEAK AROUND THE DEVICE WAS OBSERVED. APPROXIMATELY 10 MINUTES POST-IMPLANT, IT WAS OBSERVED THAT THE DEVICE DISLODGED AND HAD EMBOLIZED INTO THE LPA. THE USER ALLEGED THAT THE CAUSE OF EMBOLIZATION WAS THAT THE DEVICE WAS TOO SMALL. THE OCCLUDER WAS ATTEMPTED TO BE SNARED, HOWEVER IT WAS UNSUCCESSFUL AND THE PATIENT WAS REFERRED FOR SURGICAL REMOVAL. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115516 ↗
• MalfunctionOct 10, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5-4MM AMPLATZER PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER CONTINUOUSLY DEPLOYED WITH A DEFORMED BULGING/BULBOUS DEFORMATION AND GAVE AN "ONION" LOOKING SHAPE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT WAS EXCHANGED FOR A NEW 5-4MM AMPLATZER PDA OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED USING A NEW 5F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423860 ↗
• MalfunctionJun 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024 5MM X 4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR AN IMPLANT USING A NON-ABBOTT DEVICE. WHILE DEPLOYING THE DEVICE,THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT TAKING DESIRED SHAPE AND APPEARED COBRA, SO THE PHYSICIAN RETRIEVE THE DEVICE FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. NO DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570496 ↗
• MalfunctionFeb 8, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 6F NON-ABBOTT SHEATH. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND THEY RETRIEVED THE DEVICE BACK. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS TERMINATED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668048 ↗
• InjuryJun 26, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT FOR A 10 WEEK OLD, 2 KG PATIENT WITH THE FOLLOWING PATENT DUCTAL ARTERIOSUS (PDA) MEASUREMENTS: PULMONARY ARTERY DIAMETER OF 3.8MM, AORTIC DIAMETER OF 4.4MM, AND PDA LENGTH OF 7.9MM. THE AMPLATZER DUCT OCCLUDER WAS CHOSEN DUE TO THE MINIMUM DUCTUAL DIAMETER. AN UNKNOWN ABBOTT DELIVERY SYSTEM WAS UTILIZED. FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE USED DURING PROCEDURE FOR IMAGING. THE PATIENT WAS IN SINUS RHYTHM DURING PROCEDURE. THE DEVICE WAS DEPLOYED, AND IT INITIALLY PULLED THROUGH THE DUCT INTO THE PULMONARY ARTERY. THE DEVICE WAS RECAPTURED AND REPOSITIONED. THE DEVICE WAS EVALUATED CLOSELY PRIOR TO RELEASE, AND IT WAS POSITIONED AT THE PULMONARY ARTERY END OF THE DUCT WITH MILD LEFT PULMONARY ARTERY OBSTRUCTION AND NO AORTIC INVOLVEMENT. A STABILITY CHECK WAS PERFORMED PRIOR TO RELEASE. UPON RELEASE, THE DEVICE MOVED FORWARD IN THE DUCT TOWARDS THE AORTA. POST IMPLANT REVEALED AN AORTIC OBSTRUCTION WITH A PEAK GRADIENT OF 9MMHG. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR EVALUATION. ON (B)(6) 2023, THE PATIENT HAD OPEN HEART SURGERY TO EXPLANT THE DEVICE. A SU

  Patient problems: Obstruction/Occlusion

  MAUDE report 17199534 ↗
• MalfunctionMar 16, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER WAS UNABLE TO BE INSERTED FROM THE LOADER INTO THE DELIVERY SYSTEM. IT ALSO NOTED THAT THE OCCLUDER BECAME PREMATURELY DETACHED FROM THE DELIVERY CABLE AND STUCK IN THE PART OF THE DELIVERY SYSTEM THAT WAS OUTSIDE OF THE PATIENT. THE PATIENT DOES NOT HAVE A TORTUOUS ANATOMY AND THERE WAS NO KINK OR ANGULATION NOTED ON THE 5F AMPLATZER TORQVUE DELIVERY SYSTEM. THE 5-4MM AMPLATZER DUCT OCCLUDER WAS NOT MISHANDLED OR DAMAGED AT ANY POINT DURING DEVICE PREPARATION. THE 5-4MM AMPLATZER DUCT OCCLUDER WAS SIZED USING ANGIOGRAM MEASUREMENTS. THE DECISION WAS MADE TO CUT THE 5F AMPLATZER TORQVUE DELIVERY SYSTEM, REMOVE IT, SUCCESSFULLY RETRIEVE THE DETACHED 5-4MM AMPLATZER DUCT OCCLUDER, REATTACHED THE OCCLUDER TO THE DELIVERY CABLE, AND SUCCESSFULLY IMPLANT IT USING A REPLACEMENT 6F AMPLATZER TORQVUE DELIVERY SYSTEM. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556900 ↗
• MalfunctionNov 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 6F NON-ABBOT SHEATH. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS NOT DEPLOYING INTO THE CORRECT SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714306 ↗
• InjuryApr 3, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2022, A 5/4MMAMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. AFTER IMPLANTING THE DEVICE IT EMBOLIZED. THE DEVICE WAS EXPLANTED. THE PATIENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 13992391 ↗
• MalfunctionMar 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE AS THE DEVICE WAS BEING DEPLOYED, THE PHYSICIAN FELT AS IF THERE WAS SOME RESISTANCE WHEN DEPLOYING THE DEVICE, SO THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS AN UNKNOWN DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE DEVICE WITH ANOTHER 5-4MM AMPLATZER DUCT OCCLUDER. 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 13853813 ↗
• InjuryOct 28, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 5/4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE OCCLUDER EMBOLIZED INTO THE DESCENDING AORTA AND RETRIEVED VIA SNARE. A NEW 3/6MM AMPLATZER DUCT OCCLUDER II WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715743 ↗
• MalfunctionJul 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2021, A 3MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, A DEFORMATION WAS NOTED IN THE DESCENDING AORTA. THE DEVICE WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201917 ↗
• InjuryJul 5, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  USER FACILITY MEDWATCH RECEIVED STATES, ON (B)(6) 2021. A 3 MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE. DURING THE PROCEDURE THE DEVICE WAS POSITIONED IN THE INTENDED POSITION AND WAS RELEASED FROM THE CABLE AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THERE WAS A SHUNT OBSERVED AROUND THE DEVICE ON AN ECHOCARDIOGRAM. THIS CAUSED CONCERN AND THE USER ATTEMPTED TO RETRIEVE THE DEVICE AFTER IMPLANT. THE DEVICE EMBOLIZED DURING THE RETRIEVAL PROCESS INTO THE DESCENDING AORTA. SEVERAL ATTEMPTS WERE MADE, ANTEGRADE BUT DUE TO THE PATIENTS ANATOMY IT WAS IMPOSSIBLE. NEXT, MANIPULATIONS WERE ATTEMPTED AND THE DEVICE WAS REPOSITIONED WITHIN THE DUCTUS. A FOLLOW-UP ANGIOGRAM REVEALED THE DEVICE WAS IN A REASONABLE POSITION WITHIN THE DUCTAL AMPULLA WITH A SMALL RESIDUAL SHUNT THROUGH THE DEVICE, HOWEVER, DUE TO THE ORIGINAL EMBOLIZATION OF THE DEVICE, IT WAS NOT FELT THE POSITION WAS STABLE AND SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT UNDERWENT THE SURGICAL REMOVAL OF THE AMPLATZER DUCT OCCLUDER. THE SURGEON FOUND A LARGE TORTUOUS PDA, AND NOTED THAT THE OCCLUDER DEVICE COULD BE FELT IN THE AORTA AT THE ISTHMUS, BUT WAS NOT O

  Patient problems: Embolism/Embolus

  MAUDE report 12116432 ↗
• InjuryJul 29, 2020Difficult to Insert; Migration or Expulsion of Device; Difficult to Insert; Migration or Expulsion of Device

  ON (B)(6) 2020, AN AMPLATZER DUCT OCCLUDER (9-PDA-003) WAS SELECTED FOR IMPLANT IN THE PATIENT USING A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT, BUT IT WAS IMPOSSIBLE TO ADVANCE THE AMPLATZER DUCT OCCLUDER ONTO THE DELIVERY SYSTEM. THERE WAS RESISTANCE FELT AT THE CONNECTION WITH THE LOADING TUBE AND THE INITIAL PART OF THE DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO EXCHANGE THE DELIVERY SYSTEM FOR A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WAS NO RESISTANCE FELT AND THE AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED IN THE PATIENT WITH NO SIGNIFICANT DELAY IN THE PROCEDURE. A FEW SECONDS AFTER THE DEVICE WAS PLACED IN THE PATIENT, THE DEVICE EMBOLIZED TO THE LEFT ILIAC ARTERY OF THE PATIENT. THE DEVICE WAS SNARED THROUGH A 10F INTRODUCER WITH NO PATIENT COMPLICATIONS. IMMEDIATELY AFTER THE DEVICE WAS REMOVED, THE PHYSICIAN IMPLANTED A LARGER AMPLATZER DUCT OCCLUDER (9-PDA-005) WITH THE 6F AMPLATZER TORQVUE DELIVERY SYSTEM WITH NO COMPLICATIONS. THE PATIENT EXPERIENCED NO SERIOUS INJURIES AND IS CURRENTLY DISCHARGED.

  Patient problems: Embolism; No Known Impact Or Consequence To Patient

  MAUDE report 10339160 ↗
• MalfunctionJun 18, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 AN AMPLATZER DUCT OCCLUDER THAT WAS IMPLANTED WAS DISCOVERED TO HAVE A BULBOUS DEFORMATION JUST AFTER IMPLANT. IT WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND CONTINUES TO REMAIN STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10170432 ↗
• MalfunctionJan 20, 2020Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  ON (B)(6) 2019, A 5/4 MM PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A TORQVUE DELIVERY SYSTEM 5FR 90/080. DURING THE PROCEDURE, THE OCCLUDER FAILED TO ADVANCE INTO THE DELIVERY SHEATH. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, BUT IT REMAINED STUCK IN THE LOADING SYSTEM. A NEW 5/4MM PDA OCCLUDER AND TORQVUE 5FR 90/080 WERE SELECTED. UPON ADVANCEMENT, THE OCCLUDER WAS STUCK IN THE SHEATH AGAIN, BUT THIS TIME IT WAS SUCCESSFULLY RETRIEVED INTO THE LOADING SYSTEM. A THIRD DELIVERY SYSTEM TORQVUE 6FR WAS SELECTED AND SUCCESSFULLY USED TO IMPLANT THE SECOND PDA OCCLUDER. THE PATIENT IS REPORTED TO BE STABLE. MANUFACTURER REPORT NUMBER: 2135147-2020-00019, 2135147-2020-00020, 2135147-2020-00005.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9606814 ↗
• MalfunctionJan 20, 2020Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  ON (B)(6) 2019, A 5/4 MM PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A TORQVUE DELIVERY SYSTEM 5FR 90/080. DURING THE PROCEDURE, THE OCCLUDER FAILED TO ADVANCE INTO THE DELIVERY SHEATH. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, BUT IT REMAINED STUCK IN THE LOADING SYSTEM. A NEW 5/4MM PDA OCCLUDER AND TORQVUE 5FR 90/080 WERE SELECTED. UPON ADVANCEMENT, THE OCCLUDER WAS STUCK IN THE SHEATH AGAIN, BUT THIS TIME IT WAS SUCCESSFULLY RETRIEVED INTO THE LOADING SYSTEM. A THIRD DELIVERY SYSTEM TORQVUE 6FR WAS SELECTED AND SUCCESSFULLY USED TO IMPLANT THE SECOND PDA OCCLUDER. THE PATIENT IS REPORTED TO BE STABLE. MANUFACTURER REPORT NUMBER: 2135147-2020-00019, 2135147-2020-00020, 2182269-2020-00001.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9606798 ↗
• InjuryDec 18, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 5/4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED. THREE HOURS AFTER THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS RECOVERING IN THE NICU, THE DEVICE EMBOLIZED TO THE DESCENDING AORTA. A 5F BIOPTOME WAS USED TO GRAB THE PA SIDE PIN (END SCREW) AND THE DEVICE WAS SMOOTHLY RESHEATHED AND REMOVED. A LARGER AMPLATZER DUCT OCCLUDER WAS USED TO CLOSE THE PDA. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Information

  MAUDE report 8173386 ↗
• InjuryAug 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A 5/4 MM AMPLATZER DUCT OCCLUDER (ADO) WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ADO WAS UNABLE TO BE DIRECTED TOWARD THE PULMONARY ARTERY SIDE WHEN THE ADO DEPLOYED IN AND DETACHED FROM THE DELIVERY CABLE AT THE PATIENT'S DUCTUS. TO REPLACE THE ADO WITH A LARGER MODEL 6/4 MM ADO, THE SMALLER ADO WAS ATTEMPTED TO BE REMOVED FROM THE DUCTUS VIA A 9F AMPLATZER TORQVUE 45° EXCHANGE SYSTEM (EITV) (MODEL: 9-EITV09F45/80, LOT: 5578020). AS THE PATIENT'S AORTA WAS TOO THIN DUE TO DOWN'S SYNDROME, THE ADO WAS ATTEMPTED TO BE RETRACTED VIA A VENOUS APPROACH. THE EITV DELIVERY SHEATH WAS DELIVERED THROUGH THE PULMONARY VEIN AND THE RETRACTION OF THE ADO CONTINUED. THE LARGE 9F SHEATH HAD BEEN PLACED IN THE RIGHT VENTRICLE AND THE PATIENT DEVELOPED AN EPISODE OF PULMONARY HYPERTENSION WITH A GRADUAL DECREASE IN BLOOD PRESSURE AND REQUIRED SURGICAL INTERVENTION TO REMOVE THE ADO AND SURGICALLY CLOSE THE PATIENT'S DUCTUS. THERE WERE NO CONSEQUENCES TO THE PATIENT REPORTED AND THE PATIENT IS STABLE AND HAS BEEN DISCHARGED. THE PHYSICIAN RECOGNIZED THAT THE PATIENT'S ANATOMY ON THE PULMONARY ARTERY SIDE SHOULD HAVE BEEN CONSIDERED MORE CAREFULLY PRIOR TO DETACHMENT OF THE AD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817964 ↗