Amplatzer™ 9-PDA-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00811806011127), received between Aug 27, 2018 and Sep 29, 2026 — classified as 25 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (40 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941143 ↗
• MalfunctionMay 4, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, AN 8-6MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS OBSERVED THAT OCCLUDER CONFORMED INTO A COBRA-LIKE DEFORMATION. 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 USING 10-8MM AMPLATZER PDA OCCLUDER ALONG WITH THE SAME 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 25075970 ↗
• InjuryMar 6, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT 8-6MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. INITIALLY, THE PHYSICIANS ELECTED TO ATTEMPT CLOSURE OF THE DUCT USING A 12/8 VASCULAR PLUG. DURING THE PROCEDURE, THE 12/8 VASCULAR PLUG WAS DETERMINED TO BE OVERSIZED AND THEREFORE INEFFECTIVE FOR THE INTENDED PURPOSE. AS A RESULT, THE TEAM DECIDED TO REMOVE THE VASCULAR PLUG AND PROCEED WITH THE USE OF A DEVICE SPECIFICALLY DESIGNED FOR PATENT DUCTUS ARTERIOSUS CLOSURE. FOLLOWING THIS DECISION, THE AMPLATZER DUCT OCCLUDER (ADO) WAS IMPLANTED VIA VENOUS ACCESS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. DEVICE SIZING AND PROCEDURAL GUIDANCE WERE PERFORMED USING FLUOROSCOPY, AND THE DEFECT MEASURED 2.2MM AT THE PULMONARY END, 5.6MM AORTIC AMPULLA, WITH A TOTAL CANAL LENGTH OF 21.3MM. A STABILITY CHECK WAS PERFORMED, WITH THE TEAM WAITING 5 MINUTES PRIOR TO RELEASE, AND NO PERIDEVICE LEAK WAS DETECTED AT THAT TIME. APPROXIMATELY FIVE MINUTES AFTER DEVICE RELEASE, EMBOLIZATION WAS IDENTIFIED ON PROSTHESIS FLUOROSCOPY, WITH THE DEVICE MIGRATING TOWARD THE AORTA. DUE TO THE EMBOLIZATION, THE PATIENT WAS REFERRED TO CARDIAC SURGERY; THE ADO DEVICE WAS SURGICALLY REMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537169 ↗
• MalfunctionMar 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, AN 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F SHEATH. WHILE DEPLOYMENT, THE AORTIC SIDE OF THE DEVICE WAS NOT TAKING ITS PROPER SHAPE. THE DELIVERY SCREW OF THE DEVICE WAS NOT IN LINED WITH THE DEVICE ALIGNMENT. SO, PHYSICIAN HAS TO REPLACE THE DEVICE. AS THE PATIENT WAS ON RETROVIRAL THERAPY DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531541 ↗
• MalfunctionFeb 2, 2026Material Deformation

  IT WAS REPORTED THAT (B)(6) 2026, A 8-6MM AMPLATZER PDA DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTED THAT THE DELIVERY SCREW OF THE DEVICE WAS NOT PROPERLY ALIGNED. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES, BUT THE ISSUE WAS PERSISTENT. IT WAS ALSO REPORTED THAT BOTH THE DELIVERY SYSTEM AND THE OCCLUDER CAME IN CONTACT WITH THE PATIENT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A 10-8MM AMPLATZER PDA 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 24240438 ↗
• InjuryJan 7, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8-6MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT FOR PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE. INITIALLY, THE PHYSICIAN ATTEMPTED TO USE A 6 MM AVP2 DEVICE, WHICH WAS DETERMINED TO BE TOO SMALL. A SUBSEQUENT ATTEMPT WITH AN 8 MM AVP2 DEVICE ALSO PROVED UNSUITABLE. WHILE THE 8 MM AVP2 DEVICE REMAINED ATTACHED WITHIN THE PDA, A CONTRAST INJECTION WAS ADMINISTERED, AND THE PDA DEFECT WAS RE-MEASURED.THE DIMENSIONS OF THE DEFECT WERE REPORTED AS PA AMPULLA 4.27 MM, MID PDA 4.97 MM, AND AORTIC AMPULLA 9.21 MM. FOLLOWING THIS ASSESSMENT, THE PHYSICIAN REMOVED THE AVP2 DEVICE SAFELY AND SUCCESSFULLY IMPLANTED AN 8-6 MM AMPLATZER PDA OCCLUDER USING AN UNKNOWN DELIVERY SYSTEM. THE PHYSICIAN STATED THAT THE SIZING OF THE DEVICE WAS DETERMINED BASED ON FLUOROSCOPIC MEASUREMENTS WITH CONTRAST INJECTION. A STABILITY CHECK WAS PERFORMED PRIOR TO RELEASE, WHICH INCLUDED INJECTING CONTRAST TO VIEW THE OPPOSITION OF THE DEVICE TO THE DEFECT AND WAITING FOR 10 MINUTES WITH THE DEVICE ATTACHED TO CHECK FOR ANY CHANGES. THERE WERE NO RECAPTURES OF THE 8-6 MM AMPLATZER PDA OCCLUDER DEVICE DURING IMPLANTATION, AND NO RHYTHM CHANGES OCCURRED DURING THE PROCEDURE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995851 ↗
• MalfunctionNov 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8-6MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN NON- ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DEFORMITY IN THE AORTA, THE DEVICE DEFORMED INTO BULBOUS LIKE DEFORMATION. 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 ABORTED. 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 23650322 ↗
• MalfunctionNov 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649536 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8-6MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE AROTA DISC OF THE PDA OCCLUDER DID NOT OPEN WELL. THE DEVICE TOOK FORM OF A COBRA DEFORMATION. 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 USING ANOTHER 8-6MM AMPLATZER PDA 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 23623933 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8-6MM AMPLAZTER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE DISTAL DISC DEFORMED INTO A PUFFED CONFIGURATION. 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 USING A 10-8 MM AMPLATZER PDA OCCLUDER. 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 23622492 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460667 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100968 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8-6 MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT OF THE DEVICE FROM THE SHEATH, THE DEVICE TOOK FORM OF A COBRA DEFORMATION. AS A RESULT, THE DEVICE WAS RETRIEVED BACK INTO THE SHEATH WITHOUT BEING RELEASED, AND THE PROCEDURE WAS DISCONTINUED. DUE TO TIME CONSTRAINTS, A REOPERATION IS PLANNED FOR A LATER DATE. IT IS REPORTED THAT THE DEFORMED DEVICE WAS NEVER RELEASED FROM DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. IT IS REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100510 ↗
• MalfunctionAug 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909588 ↗
• MalfunctionAug 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904581 ↗
• MalfunctionAug 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025 AN 8-6MM AMPLATZER PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 6F AMPLATZER TORQVUE 180/80 DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER DEVELOPED A COBRA DEFORMATION. MULTIPLE DEPLOYMENTS WERE ATTEMPTED IN AN EFFORT TO RESOLVE WITHOUT SUCCESS. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874900 ↗
• InjuryJun 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEFECT MEASURE 4X4. THE SIZING OF THE DEVICE WAS MEASURED VIA COMPUTED TOMOGRAPHY (CT) AND ANGIOGRAM; FLUOROSCOPY WAS UTILIZED DURING IMPLANT. DURING IMPLANT, STABILITY CHECK WAS PERFORMED AND NO LEAK WAS OBSERVED; THE OCCLUDER WAS RELEASED FROM THE DELIVERY CABLE. AFTER THE OCCLUDER WAS RELEASED, IT DISLODGED AND EMBOLIZED INTO A BRANCH OF THE RIGHT PULMONARY ARTERY. THE DEVICE DID NOT CAUSE BLOCKAGE. THE OCCLUDER WAS RETRIEVED USING BIOPTOME FORCEPS AND SUCCESSFULLY REMOVED FROM THE PATIENT. THE PHYSICIAN BELIEVED THAT THEY HAD "INADVERTENTLY RETRACTED THE RETAINING SKIRT INTO THE SHEATH" WHEN THEY WERE "PULLING BACK TO SEAT IT ON THE AMPULLA, THUS PLACING IT WITHIN THE DUCT INSTEAD OF AT THE AMPULLA." "THE PHYSICIAN DOES NOT BELIEVE SIZING WAS AN ISSUE." NO DEVICE WAS ULTIMATELY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285452 ↗
• MalfunctionJun 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS ON THE DELIVERY SHEATH. 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 22235655 ↗
• MalfunctionApr 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING AN UNKNOWN DELIVERY SYSTEM. THE DEVICE WAS PLACED DEEP IN COMPLEX PDA. AFTER THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS EMBOLIZED TO PULMONARY ARTERY (PA). THE EMBOLIZED DEVICE WAS DISCOVERED DURING WORK UP FOR RESPIRATORY SYNCYTIAL VIRUS (RSV) INFECTION. THEY ARE WAITING FOR THE REMOVAL OF DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Respiratory Tract Infection

  MAUDE report 21787512 ↗
• InjuryMar 7, 2025Material Protrusion/Extrusion; Patient Device Interaction Problem; Material Protrusion/Extrusion; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON 06 FEBRUARY 2025, A 8-6MM AMPLATZER DUCT OCCLUDER II (LOT: 10395115) WAS CHOSEN FOR IMPLANTATION INTO PATENT DUCTUS ARTERIOSUS (PDA) UTILIZING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 10482218). THE DEVICE WAS PLACED IN THE PDA, BUTTHE PLACEMENT WAS NOT IN THE USUAL STATE DUE TO THE SHAPE OF THE PDA SO THE DEVICE WAS REMOVED AND RE-EXAMINED OUTSIDE OF THE ANATOMY. UPON INSPECTION, FIBER-LIKE MATERIAL (POSSIBLY THROMBUS) WAS OBSERVED ATTACHED TO THE OCCLUDER ALONG WITH THREADS. AS A PRECAUTION, THE OCCLUDER AND DELIVERY SYSTEM WERE EXCHANGED. NO ADDITIONAL ANTICOAGULANT WAS GIVEN. THE REPLACEMENT 8-6MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED SUCCESSFULLY UTILIZING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21547808 ↗
• InjuryMar 3, 2025Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE SIZE OF THE DEFECT WAS 4MM COMPUTED TOMOGRAPHY (CT) VISUALIZATION WAS DIFFICULT ON ANGIOGRAPHY LOOKED TO BE CLOSE TO 4 MM AROUND 12 MM AORTIC AMPULLA ON CT AND AGAIN AGIO DIFFICULT ON AORTIC AMPULLA. THE DEVICE WAS PREPARED IN STANDARD FASHION AND THE PHYSICIAN VERIFIED THE DEVICE WAS JUST UNLOCKED OFF CLICK BEFORE ATTEMPTING PLACEMENT. DURING PROCEDURE, THE PLACEMENT WAS DIFFICULT DUE TO LIMITED VISUALIZATION OF THE PDA AND THE DEVICE DURING DEPLOYMENT. THE FLUOROSCOPY (FLURO) IMAGE WAS A BIT GRAY DURING THE DURATION OF THE PROCEDURE AND THE DEVICE WAS UNDER COUNTER TRACTION WITH THE CATHETER OCCASIONALLY SLIDING ON THE CABLE WITH HEART CONTRACTIONS. THE DEVICE FELL OF THE CABLE OF THE DELIVERY SYSTEM AND EMBOLIZED TO THE PATIENT LEFT FEMORAL ARTERY AND THERE WAS PARTIAL OBSTRUCTION/BLOCKAGE OF BLOOD FLOW. THERE WAS NO DIRECT VISUALIZATION OF THE DEVICE COMING OFF THE CABLE IT OCCURRED IN BETWEEN FLUOROSCOPY IMAGES. A NEW 6MM BY 6MM AMPLATZER DUCT OCCLUDER II, A CABLE FORM THE AMPLATZER TORQVUE LP DELIVERY SY

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 21506844 ↗
• MalfunctionFeb 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, IT WAS NOTED THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO RETRIEVE THE DEVICE PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE COMPLAINT DEVICE WAS ALSO TESTED OUTSIDE OF PATIENT ANATOMY AND CONTINUED TO HAVE THE SAME COBRA DEFORMATION. A NEW 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398992 ↗
• MalfunctionJan 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON 14 DECEMBER 2024 USING A 6F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER 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 21092396 ↗
• MalfunctionDec 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8-6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE REPOSITIONED THREE TIMES, HOWEVER THE COBRA SHAPE MAINTAINED. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 6-4MM AMPLATZER DUCT OCCLUDER. 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 21037115 ↗
• MalfunctionOct 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). IT WAS DIFFICULT TO CONNECT THE LOADER TO THE DELIVERY SHEATH. THERE WAS ALSO RESISTANCE WHILE ADVANCING THE OCCLUDER INTO THE DELIVERY SHEATH. THE OCCLUDER WAS DEPLOYED IN THE PDA, AND THE DEVICE HAD A COBRA DEFORMATION. THE DEVICE WAS RETRACTED BACK INTO THE DELIVERY SHEATH. THERE WERE NO BEND OR KINK IN THE DELIVERY SYSTEM. THE DEVICES WERE EXCHANGED WITH ANOTHER 8-6MM AMPLATZER DUCT OCCLUDER AND ANOTHER 6F AMPLATZER TORQVUE DELIVERY SYSTEM, AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429076 ↗