Amplatzer™ 9-PDA-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00811806011110), received between Aug 27, 2018 and Apr 7, 2026 — classified as 13 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (24 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 6-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS NOTED THAT THE DEVICE CONTINUOUSLY SHOWED BULGING AND GAVE AN "ONION" LOOKING SHAPE AT THE DISC. THE PROCEDURE WAS COMPLETED USING A NEW 6-4MM AMPLATZER PDA OCCLUDER. 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 24809859 ↗
• MalfunctionMar 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 6-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE CLOSING THE PDA, IT WAS OBSERVED THAT THE OCCLUDER COULD NOT BE ADVANCED IT THROUGH THE CONNECTION BETWEEN INTRODUCER AND THE DELIVERY SHEATH. THE PHYSICIAN TRIED DETACHING AND FLUSHING BEFORE REATTACHING THE OCCLUDER BUT IT STILL COULD NOT BE ADVANCED. WHEN THE OCCLUDER WAS ATTEMPTED TO RELOAD IT WAS NOTED THAT THE OCCLUDER LOOKED DISTORTED AND THEREFORE THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A 5-4MM AMPLATZER PDA OCCLUDER WHICH ADVANCED THROUGH THE 6F AMPLATZER TORQVUE DELIVERY SYSTEM, BUT IT WAS NOTED THAT THERE WAS SLIGHT RESISTANCE FELT WHILE ADVANCING UPWARDS. 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 24617928 ↗
• MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550857 ↗
• InjuryFeb 20, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 5-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. THE PHYSICIAN DETERMINED THE SIZING USING FLUOROSCOPY IMAGING, AND THE DEVICE WAS ASSESSED TO BE MIS-SIZED FOR THE PATIENT¿S PATENT DUCTUS ARTERIOSUS (PDA). THE DEVICE WAS SUBSEQUENTLY REMOVED WITHOUT BEING RELEASED FROM THE DELIVERY CABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THIS PORTION OF THE PROCEDURE, AND NO ALLEGATIONS REGARDING THE SIZING OF THIS DEVICE WERE REPORTED. A SECOND DEVICE, A 6¿4 MM AMPLATZER PDA OCCLUDER, WAS THEN SELECTED. THE SIZING FOR THIS IMPLANT WAS DETERMINED USING ANGIOGRAPHY, AND FLUOROSCOPY WAS USED THROUGHOUT THE PROCEDURE. THE PHYSICIAN DETERMINED THIS DEVICE TO BE THE APPROPRIATE SIZE AND PROCEEDED WITH DEPLOYMENT. UPON RELEASE, THE DEVICE WAS OBSERVED TO ¿JUMP¿ SLIGHTLY TOWARD THE AORTA, THOUGH IT WAS NOTED TO APPEAR STABLE WITHIN THE PDA WITH NO INDICATIONS OF MIGRATION AT THAT TIME. NO LEAK WAS BELIEVED TO BE PRESENT, AND NO RHYTHM CHANGES OR OTHER CLINICAL SYMPTOMS WERE REPORTED DURING THE PROCEDURE. NO CONCERNS RELATED TO SIGNIFICANT DELAY OR HEMODYNAMIC COMPROMISE WERE REPORTED DURING THE PROCEDURE. SEVERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405539 ↗
• InjuryFeb 11, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 6-4MM AMPLATZER PDA WAS IMPLANTED USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT A DUCTUS ARTERIOSUS DEFECT MEASURING 4 MM AT THE AORTIC END AND 2 MM AT THE PULMONARY END, WITH DEVICE SIZING DETERMINED BASED ON THESE MEASUREMENTS AND THE CONICAL ANATOMY OF THE DUCTUS. THE PROCEDURE WAS PERFORMED USING ANGIOGRAPHIC IMAGING. A STABILITY CHECK WAS PERFORMED, AND THE PHYSICIAN REPORTED NO SIGNIFICANT PERI-DEVICE LEAK AND NO DIFFICULTY DURING IMPLANTATION, INCLUDING NO NEED FOR MULTIPLE RECAPTURES OR REPOSITIONING. NO RHYTHM CHANGES WERE OBSERVED DURING THE PROCEDURE. APPROXIMATELY 1 HOUR AND 20 MINUTES AFTER DEVICE RELEASE, THE PHYSICIAN REVIEWED A CHEST X-RAY, WHICH CONFIRMED THAT THE DEVICE HAD COMPLETELY DISLODGED FROM THE IMPLANT SITE AND EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE IMPLANTER BELIEVED THE EMBOLIZATION MAY HAVE OCCURRED BECAUSE AFTER RELEASE, THE DISC SHIFTED INTO THE DUCTUS ARTERIOSUS, AND LATER CONSIDERED THE PATIENT WAS LIKELY NOT WELL HYDRATED. THE EMBOLIZED DEVICE DID NOT CAUSE PARTIAL OR COMPLETE OBSTRUCTION OF BLOOD FLOW, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. TO ADDRESS THE EMBOLIZATION, THE PHYSICIAN P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317825 ↗
• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6-4MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS OBSERVED THAT THE DEVICE DID NOT CONFORM TO ITS DESIRED SHAPE FROM THE BEGINNING, IT CONFORMED INTO BULBOUS DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NEW 6-4MM AMPLATZER PDA OCCLUDER. 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 24098537 ↗
• MalfunctionOct 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, 6-4MM AMPLATZER PDA DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE PDA DISC DEFORMED INTO A SKIRT DEFORMATION. THE PROCEDURE WAS COMPLETE USING A 6-4MM AMPLATZER PDA DUCT OCCLUDER. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271574 ↗
• MalfunctionJun 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON AN UNUSUAL SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLER AND WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS TO THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329507 ↗
• MalfunctionJun 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. DURING PREPARATION, THE PHYSICIAN ATTEMPTED TO LOAD THE OCCLUDER INTO THE DELIVERY SYSTEM. HOWEVER, THIS WAS NOT POSSIBLE AND THE SHEATH WAS EXCHANGED FOR A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE OCCLUDER WAS SUCCESSFULLY LOADED INTO THE NEW TORQVUE AND INTRODUCED INTO THE PATIENT. DURING IMPLANT, UPON DEPLOYMENT, THE OCCLUDER DEFORMED WITH A COBRA SHAPE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE OCCLUDER WAS EXCHANGED FOR A NEW 6-4MM AMPLATZER DUCT OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324802 ↗
• MalfunctionApr 8, 2025Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 6F AMPLATZER TORQVUE 180 DELIVERY SYSTEM. THERE WAS DIFFICULTY WHEN ATTEMPTING TO PULL THE OCCLUDER INTO THE LOADER BUT WAS EVENTUALLY SUCCESSFULLY. UPON DEPLOYMENT OF THE DEVICE, THE OCCLUDER WAS DEFORMED IN A BULBOUS SHAPE. IT WAS DECIDED TO RELEASE THE OCCLUDER DESPITE THE DEFORMATION AS THE SHUNT WAS OBLITERATED AND THERE WAS A DOGBONE LOOK TO THE PROXIMAL DEVICE. ONCE DEPLOYED, THE OCCLUDER REGAINED A NORMAL SHAPE. THE PATIENT WAS REPORTED TO BE STABLE AND NO CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21800691 ↗
• MalfunctionMar 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2025 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT A PATENT DUCTUS ARTERIOSUS (PDA). BOTH DEVICES WERE PREPARED PER IFU. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED ONCE. WHEN THE OCCLUDER WAS PLACED ON THE PDA THE OCCLUDER TOOK ON AN EXTENDED SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. BOTH THE OCCLUDER AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 8-6MM AMPLATZER DUCT OCCLUDER AND 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE USER BELIEVED THE OCCLUDER DEFORMATION MAY HAVE BEEN RELATED TO THE CONNECTION TO THE DELIVERY CABLE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709724 ↗
• MalfunctionMar 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM (DS). THERE WERE NO ISSUES NOTED DURING DEVICE PREP. DURING THE PROCEDURE, THERE WAS NO DIFFICULTY TRAVERSING THE HUB; HOWEVER, THE INNER DIAMETER OF THE SHEATH WAS NOTED TO BE EXTREMELY TIGHT MAKING IT DIFFICULT TO ADVANCE THE OCCLUDER. THE DS WAS REPLACED WITH A SECOND 6F AMPLATZER TORQVUE DS, BUT THE SAME ISSUE OCCURRED. THIS RESULTED IN DEFORMITY OF THE AMPLATZER DUCT OCCLUDER (B/L# 10362650). AFTER MUCH EFFORT, THE DEVICE EVENTUALLY EXITED THE SHEATH AND WAS POSITIONED CORRECTLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES, BUT THE PROCEDURE PROLONGED AND THERE WAS THE POSSIBILITY OF SHEARING MICROPLASTICS INTO THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538264 ↗
• MalfunctionJan 13, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6-4 MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE PRESENTED IN A DEFORMATION. THE DEVICE WAS REMOVED AND REPLACED WITH A 6-4 MM AMPLATZER DUCT OCCLUDER TO RESOLVE THE EVENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143578 ↗
• MalfunctionJan 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8-6MM AMPLATZER DUCT OCCLUDER (10031150) WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM (910316837). DURING IMPLANT THE OCCLUDER TOOK ON A DEFORMED SHAPE ON THE PULMONARY ARTERY SIDE. THE MESH ON THE PULMONARY ARTERY SIDE WAS NOTED TO FOLD INWARDS. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY SYSTEM. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 6-4MM AMPLATZER DUCT OCCLUDER (10362112) USING A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM (10404085). DURING IMPLANT THE DEVICE ALSO TOOK ON A DEFORMED SHAPE AS SEEN WITH THE FIRST OCCLUDER. THE OCCLUDER WAS CONFORMED BACK TO ITS ORIGINAL SHAPE AND SUCCESSFULLY IMPLANTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129637 ↗
• MalfunctionJan 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8-6MM AMPLATZER DUCT OCCLUDER (10031150) WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM (910316837). DURING IMPLANT THE OCCLUDER TOOK ON A DEFORMED SHAPE ON THE PULMONARY ARTERY SIDE. THE MESH ON THE PULMONARY ARTERY SIDE WAS NOTED TO FOLD INWARDS. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY SYSTEM. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 6-4MM AMPLATZER DUCT OCCLUDER (10362112) USING A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM (10404085). DURING IMPLANT THE DEVICE ALSO TOOK ON A DEFORMED SHAPE AS SEEN WITH THE FIRST OCCLUDER. THE OCCLUDER WAS CONFORMED BACK TO ITS ORIGINAL SHAPE AND SUCCESSFULLY IMPLANTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129618 ↗
• InjuryDec 19, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). FLUROSCOPY WAS USED TO DETERMINE THE SIZE OF THE DEVICE. THE PDA WAS 0.2MM ON THE PULMONARY ARTERY SIDE. THE PATIENT HAD A TYPE-A PDA MORPHOLOGY. THE DEVICE WAS DEPLOYED IN THE PDA UNDER FLUOROSCOPY AFTER A STABILITY CHECK WAS PERFORMED. NO LEAK WAS OBSERVED. THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE. AFTER DETACHMENT, THE DEVICE COMPLETELY DISLODGED TO THE AORTIC SIDE AND TRAVELLED TO THE ABDOMINAL AORTA. THE DEVICE WAS RETRIEVED PERCUTANEOUSLY. DURING RETRIEVAL, WHEN THE DEVICE WAS PULLED INTO THE SHEATH, THE DEVICE BECAME ANGLED, RESULTING IN A DEFORMED SHAPE. ANOTHER 6-4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED USING THE SAME DELIVERY SYSTEM. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE EMBOLIZATION WAS POSSIBLY DUE TO THE DEVICE NOT BEING SUFFICIENTLY PULLED INTO THE PULMONARY ARTERY SIDE. 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 20981382 ↗
• MalfunctionAug 22, 2024Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE THERE WAS DIFFICULTY ADVANCING THE DELIVERY SHEATH THROUGH THE PATIENT ANATOMY. THERE WAS ALSO DIFFICULTY LOADING THE OCCLUDER INTO THE DELIVERY SHEATH. EXCESSIVE FORCE WAS USED TO PUSH THE OCCLUDER INTO THE DELIVERY SHEATH, CAUSING THE DISC OF THE OCCLUDER TO FORM AN S-SHAPE AND THE DELIVERY SHEATH TO KINK. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER AND DELIVERY SHEATH WERE BOTH REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 6-4MM AMPLATZER DUCT OCCLUDER AND 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044466 ↗
• MalfunctionAug 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, THE DEVICE WAS BEING DEPLOYED, BUT THE PULMONARY ARTERY END PRESENTED IN A BULBOUS DEFORMATION. THE DEVICE WASN'T RELEASED FROM THE DELIVERY CABLE AND THE CASE WAS ABANDONED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012214 ↗
• MalfunctionJul 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784682 ↗
• MalfunctionFeb 28, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6). 2024, A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. WHEN LOADING, THE PHYSICIAN NOTICE THAT THE DISC ENTERS THE SHEATH IN AN UNUSUAL WAY. WHEN POSITIONING THE DEVICE, IT CAME OUT IN A COBRA SHAPE AND NEVER TOOK THE CORRECT FINAL POSITION. THE PHYSICIAN RECHARGE THE DEVICE BUT IT NEVER RETURNED TO ITS USUAL SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. HE CHANGED THE DEVICE, THE NEW ONE CHARGES AND DEPLOYS IN THE USUAL WAY. PATIENT STABLE AFTER THE PROCEDURE. INCREASE OF THE DURATION OF THE PROCEDURE DUE TO THIS CHANGE OF DEVICE BUT NO CONSEQUENCES FOR THE PATIENT. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799049 ↗
• MalfunctionFeb 28, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON(B)(6)2024 USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING IMPLANT THE LEFT DISC OF THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NON-ABBOTT DEVICE. 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 18798356 ↗
• MalfunctionDec 20, 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 WAS CHOSEN FOR IMPLANT USING A 6F DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS LOADED INTO THE LOADER, BUT DID NOT COMPLETELY RETURN TO ITS ORIGINAL UNCONSTRAINED SHAPE. THE PHYSICIAN DECIDED TO ATTEMPT TO IMPLANT THE DEVICE, BUT THE PLACEMENT LOOKED INADEQUATE AND DIDN'T RETURN TO ITS ORIGINAL SHAPE. 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. A NEW 6-4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN. 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 18366618 ↗
• InjuryOct 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, "WIRE SNARE CLOSE LOOP: A NOVEL TECHNIQUE TO RETRIEVE EMBOLIZED DEVICES", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 22-MONTH-OLD FEMALE PATIENT WITH A PATENT DUCTUS ARTERIOSUS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 6-4-MM AMPLATZER DUCTAL OCCLUDER TYPE 1 (ADO-1) WAS CHOSEN FOR IMPLANT. AFTER RELEASE OF THE DEVICE, IT WAS NOTED THE DEVICE EMBOLIZED IMMEDIATE INTO THE RIGHT PULMONARY ARTERY. A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE BUT WAS UNSUCCESSFUL. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A WIRE SNARE CLOSE LOOP NOVEL METHOD. THE ARTICLE CONCLUDED THIS NOVEL TECHNIQUE DESCRIBES A SAFE AND MORE RELIABLE METHOD TO RETRIEVE EMBOLIZED ADO-1 DEVICES. THIS TECHNIQUE CAN ALSO BE USED TO RETRIEVE OTHER EMBOLIZED DEVICES, AS AN ALTERNATIVE TO, OR WHEN OTHER STANDARD TECHNIQUES ARE NOT FEASIBLE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MANISH BANSAL, LILLIE FRANK ABERCROMBIE SECTION OF CARDIOLOGY, TEXAS CHILDREN¿S HOSPITAL, BAYLOR COLLEGE OF MEDICINE, 6651 MAIN STREET, E 1920, HOUSTON, TEXAS 77030, USA, WITH CORRESPONDING E-MAIL: [email protected]]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013034 ↗
• MalfunctionSep 11, 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 WAS CHOSEN FOR IMPLANT INTO PATENT DUCTUS ARTERIOSUS (PDA), USING 06F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE WAS NOTED TO DEFORM. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED AND A REPLACEMENT 6-4MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED. 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 17722677 ↗
• MalfunctionApr 11, 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 WAS CHOSEN FOR IMPLANT WITH A NON-ABBOTT SHEATH. THE HEALTH CARE PROFESSIONAL TRIED TO DEPLOY THE DEVICE BUT THE DEVICE WASN'T OPENING PROPERLY AND THE AORTIC END OF THE DEVICE WAS OBSERVED TO BE IN AN INAPPROPRIATE SHAPE. 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 OCCLUDER WAS NOT RELEASED FROM THE CABLE. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 5-4MM AMPLATZER DUCT OCCLUDER FOR IMPLANT WITH AN NON-ABBOTT SHEATH. THE REPLACEMENT DEVICE WAS IMPLANTED IN THE PATIENT WITH NO ADVERSE PATIENT CONSEQUENCES. 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 AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714147 ↗