Amplatzer™ 9-PDA-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00811806011134), received between Jul 17, 2018 and Apr 1, 2026 — classified as 11 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (10 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10-8MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE DO NOT TAKE PROPER SHAPE AND HAD A BULBOUS DEFORMATION. 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 PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PROCEDURE GOT ABORTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758067 ↗
• MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2026 A 10-8MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F NON-ABBOTT SHEATH. DURING DEPLOYMENT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY SHEATH AND WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546515 ↗
• MalfunctionFeb 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10-8MM AMPLATZER PDA OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 7F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA LIKE DEFORMATION. THEREFORE, THE DEVICE WAS RETRIEVED BACK AND THE PROCEDURE WAS ABORTED. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254035 ↗
• MalfunctionOct 31, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10-8 MM AMPLATZER PDA DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT CONFORMING TO ITS INTENDED SHAPE AND THE OCCLUDER TOOK FORM OF A COBRA HEAD. THEREFORE, THE PHYSICIAN HAD TO RETRIEVE THE DEFORMED DEVICE BACK. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO ANGULATION OR KINK 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 23442105 ↗
• MalfunctionApr 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 10-8MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT SHEATH. DURING PROCEDURE, WHILE DEPLOYMENT PHYSICIAN NOTED THAT THE DEVICE IS NOT TAKING ITS PROPER SHAPE AND HAD A COBRA DEFORMATION, SO HE HAD TO RETRIEVE 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 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 21743993 ↗
• InjuryFeb 3, 2025Migration or Expulsion of Device; Off-Label Use; Device Damaged by Another Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Off-Label Use; Device Damaged by Another Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 10-8MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A RUPTURED SINUS OF VALSALVA (SOV). THE DEFECT WAS MEASURED AT 6MM UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND 4.8MM UNDER ANGIOGRAPHY. A STABILITY CHECK WAS PERFORMED. THE OCCLUDER WAS IMPLANTED. APPROXIMATELY TWO WEEKS AFTER THE PROCEDURE THE PATIENT PRESENTED WITH HEMOLYSIS. ON (B)(6) 2025 A CARDIAC CATHETERIZATION SHOWED ONE RADIOPAQUE MARKER IN THE AORTIC SINUS AND ANOTHER RADIOPAQUE MARKER IN THE RIGHT PULMONARY ARTERY AND A RECURRENT SHUNT FLOWED ACROSS THE RUPTURED SOV. THE LEAK WAS MEASURED GREATER THAN 5MM. THE OCCLUDER WAS SURGICALLY REMOVED AND THE RUPTURED SOV WAS SURGICALLY CLOSED. THE RADIOPAQUE MARKER WAS NOT REMOVED FROM THE PATIENT AS IT WAS NOT CAUSING AN OBSTRUCTION. IT WAS NOTED THAT THE INFERIOR VENA CAVA (IVC) WAS PROTRUDING INTO THE RIGHT ATRIUM AND THE DECISION WAS MADE TO TRIM THE END OF THE STENT. IT WAS BELIEVED THAT THE EDGE OF THE OPEN STENT INTERACTED WITH THE OCCLUDER, THE OPEN EDGE OF THE STENT CUTTING INTO THE NITINOL WIRE BRAID OF THE OCCLUDER AND CAUSING THE DEVICE TO BREAK INTO TWO PIECES. THE PAT

  Patient problems: Hemolysis

  MAUDE report 21294462 ↗
• InjuryNov 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, IT WAS DEEMED TOO SMALL, SO A 10-8MM AMPLATZER DUCT OCCLUDER WAS CHOSEN WITH A 6F SHEATH. WHILE POSITIONING THE SECOND DEVICE, IT WAS FOUND TO BE TOO LARGE. IT WAS DECIDED TO RETRACT AND REMOVE THE DEVICE AND FOR THE PATIENT TO HAVE SURGICAL REPAIR. HOWEVER, THE DEVICE WAS UNABLE TO BE RETRACTED BACK INTO THE SHEATH. ACCORDING TO ONE OF THE OPERATORS, THE CORRECT INDICATION WOULD BE A 7F SHEATH FOR THE 10-8MM AMPLATZER DUCT OCCLUDER. THE SHEATH¿S FLEXIBLE TIP WAS CAUSING THE DEVICE TO BEND INWARDS TOWARDS THE LUMEN DURING RETRACTION. TO RESOLVE THIS A MULTIPLE CATHETERS WERE USED IN AN ATTEMPT TO GET THE PROTHESIS RETRACTED. REMOVAL WAS SUCCESSFUL BY USE OF AN 8F SHEATH VIA A VENOUS ROUTE. DURING THE PROCEDURE, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE DUE TO PROLONGED SEDATION. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO VENOUS BLEEDING CAUSED BY THE REPEATED INSERTION AND REMOVAL OF MATERIAL AND THE DURATION OF THE PROCEDURE. THE PATIENT HAD ALSO EXPERIENCED LOW CARDIAC OUTPUT. SURGERY WAS CARRIED OUT THE FOLLOWING DAY FOR SURGICAL REPAIR OF THE DEFECT. THER

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20727622 ↗
• MalfunctionNov 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 10-8MM AMPLATZER PDA OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING IMPLANT THE DEVICE TOOK ON A BULBOUS SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW NON-ABBOTT DEVICE. 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 20708612 ↗
• MalfunctionJul 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 10-8MM AMPLATZER PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT, IT WAS OBSERVED THAT THE OCCLUDER WAS NOT TAKING DESIRED SHAPE AND DEFORMED INTO A COBRA SHAPE. THEREFORE, THE OCCLUDER WAS RETRIEVED. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO ANGULATIONS/KINKS OBSERVED WITH THE DELIVERY SHEATH. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727567 ↗
• MalfunctionFeb 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6)2024, A 10-8MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F 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 18652945 ↗
• MalfunctionAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 3.5-YEAR-OLD, 12KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 7MM, AMPULLA DIAMETER = 9MM, DUCTAL LENGTH = 7MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 10-8MM AMPLATZER DUCT OCCLUDER I WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THERE WAS A RESIDUAL SHUNT AND IATROGENIC COARCTATION OF AORTA. A DECISION WAS MADE TO ADDITIONALLY IMPLANT A 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DUCT. THE SECOND DEVICE WAS IMPLANTED SUCCESSFULLY. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY, [email protected]] PERIPROCEDURAL COMPLICATIONS INCLUDED RESIDUAL SHUNT AND SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542453 ↗
• InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 3.5-YEAR-OLD, 12KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 7MM, AMPULLA DIAMETER = 9MM, DUCTAL LENGTH = 7MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 10-8MM AMPLATZER DUCT OCCLUDER I WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THERE WAS A RESIDUAL SHUNT AND IATROGENIC COARCTATION OF AORTA. A DECISION WAS MADE TO ADDITIONALLY IMPLANT A 10MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DUCT. THE SECOND DEVICE WAS IMPLANTED SUCCESSFULLY. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY, [email protected]]. PERIPROCEDURAL COMPLICATIONS INCLUDED RESIDUAL SHUNT AND SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542284 ↗
• MalfunctionDec 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 10-8MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED DURING PROCEDURE THAT THERE WAS A RESIDUAL SHUNT DETECTED VIA ANGIOGRAPHY EXAMINATION AFTER FULL DEPLOYMENT/IMPLANT OF THE OCCLUDER. THE RESIDUAL SHUNT WAS NOT CONSIDERED THE PATIENT WAS CHECKED AGAIN 24 HOURS AFTER IMPLANT AND AN ECHOCARDIOGRAM DETECTED THE SAME RESIDUAL SHUNT. THERE WAS NO INTERVENTION PERFORMED. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT AND TOLD TO CALL TO SCHEDULE A FOLLOW UP APPOINTMENT A MONTH AFTER THE IMPLANT PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040518 ↗
• MalfunctionJul 1, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 10-8MM AMPLATZER PDA DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT, THE DEVICE TOOK INAPPROPRIATE SHAPE. IT WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. IT IS UNKNOWN IF THERE WAS A DEVICE IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14889418 ↗
• MalfunctionSep 23, 2021Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 10 MM BY 8 MM AMPLATZER DUCT OCCLUDER (ADO) WAS SELECTED FOR IMPLANT IN THE PATIENT'S PATENT DUCTUS ARTERIOSUS (PDA) USING A 6 FR 180/80 AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE ADO DEVICE DID NOT DEPLOY ON THE PULMONARY ARTERY (PA) SIDE OF THE PDA. THE ADO DEVICE WAS RETRACTED BACK INTO THE DELIVERY SYSTEM ONCE AND ATTEMPTED FOR DELIVERY AGAIN, BUT THE AORTA SIDE OF THE ADO WENT INTO THE PDA AND BECAME DEFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE ADO DEFORMATION WAS CONFIRMED OUTSIDE OF THE PATIENT. A 6 MM BY 4 MM AMPLATZER DUCT OCCLUDER II WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT DEVICE TO RESOLVE THIS EVENT. THE PHYSICIAN BELIEVED THAT THE PDA CLOSURE WITH THE FIRST ADO DEVICE MAY HAVE BEEN DIFFICULT WITH THE AGE-RELATED VESSEL HARDNESS AND CALCIFICATION, AS WELL AS THE SHAPE AND LENGTH OF THE PATIENT'S PDA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521985 ↗
• InjuryJun 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021, A 6MM AMPLATZER DUCT OCCLUDER AND A 6/4MM AMPLATZER DUCT OCCLUDER II WERE IMPLANTED. POST-IMPLANT, VASCULAR HEMATOMA AND ACTIVE BLEEDING FROM THE LEFT FEMORAL PUNCTURE SITE WAS OBSERVED AND MANUAL COMPRESSION WAS APPLIED. OF NOTE, AN EPISODE OF HYPOTENSION WAS OBSERVED AND RELATED TO THE BLEEDING. THE PATIENT WAS TRANSFUSED 1 UNIT OF PACKED RED BLOOD CELLS. NO PATIENT CONSEQUENCES WERE REPORTED. ON 4 MAY 2021, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE 7F AMPLATZER TREVISIO DELIVERY SYSTEM (BATCH/LOT: 7507123) WAS USED IN THE LEFT ACCESS SITE. AN ADDITIONAL 6MM AMPLATZER DUCT OCCLUDER (BATCH/LOT: 6987723) WAS ATTEMPTED TO BE IMPLANTED, HOWEVER THE OCCLUDER EMBOLIZED TO THE PULMONARY ARTERY AND WAS RETRIEVED VIA SNARE. IN ADDITION, THE 5MM AMPLATZER DUCT OCCLUDER (BATCH/LOT: 7456394) WAS MIS-SIZED. CLINICAL STUDY PATIENT ID: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914142 ↗
• InjuryMay 11, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2021, A 6MM AMPLATZER DUCT OCCLUDER AS SELECTED FOR IMPLANT. POST IMPLANT IT WAS REPORTED THAT THE DEVICE EMBOLIZED FROM A PARAVALULAR LEAK (PVL) DUE TO AN UNKNOWN MECHANICAL VALVE. THE DEVICE WAS SNARED SUCCESSFULLY USING A 12F TREVISIO AND A ENSARE GOOSENECK SNARE. A NEW 9MM AMPLATZER DUCT OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805301 ↗
• InjuryApr 15, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00142, 2135147-2021-00144. ON (B)(6) 2021, A 8X6 MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) MONTH OLD CHILD WITH A SHORT AND WIDE PATENT DUCTUS ARTERIOSUS (PDA). DURING THE PROCEDURE, INTRODUCTION OF THE CATHETER INDUCED AN ARRHYTHMIA AND REQUIRED CARDIOVERSION TO RESOLVE. ONCE THE PATIENT RHYTHM WAS RETURNED TO NORMAL, THE DEVICE WAS IMPLANTED AND DETACHED FROM THE DELIVERY CABLE IN THE PDA. THE DEVICE THEN WAS FOUND TO HAVE EMBOLIZED INTO THE PATIENTS PULMONARY ARTERY. ANOTHER ATTEMPT WAS MADE WITH A 10X8 MM AMPLATZER DUCT OCCLUDER, BUT THIS DEVICE EMBOLIZED AS WELL. A THIRD ATTEMPT WAS MADE WITH AN 8 MM AMPLATZER VASCULAR PLUG II, BUT AGAIN THE DEVICE EMBOLIZED. ALL DEVICES WERE REMOVED AND THE PROCEDURE WAS ABORTED WITH NO DEVICE IMPLANTED. THE PATIENT IS STABLE WITH NO ADVERSE HEALTH CONSEQUENCES. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE EVENT WAS DUE TO MIS-SIZING OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675741 ↗
• MalfunctionApr 2, 2021Break; Off-Label Use; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Break; Off-Label Use; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00128. ON (B)(6) 2021, A 10-8 MM AMPLATZER DUCT OCCLUDER WAS SELECTED TO CLOSE OFF A DUCT CREATED BY A TRANSCAVAL TAVR PROCEDURE. A TORQVUE DEVICE LOADER WAS USED TOGETHER WITH AN AGILIS CATHETER. DURING THE LOADING OF THE DEVICE THERE WAS SOME RESISTANCE NOTED. THE PHYSICIAN POSITIONED THE DEVICE AND DEPLOYED THE DISTAL END (NOT FULLY), WHILE TRYING TO FIND THE OPTIMAL POSITION IT WAS NOTED THAT THE DEVICE HAD BECOME DETACHED FROM THE TORQVUE DELIVERY CABLE. AN ENSNARE WAS THEN USED TO SNARED AND REMOVE THE DEVICE THROUGH THE AGILIS CATHETER. UPON INSPECTION IT WAS NOTED THAT THE THREADS OF THE ENDSCREW OF THE TORQVUE DELIVERY CABLE BROKE OFF IN THE ENDSCREW ON THE OCCLUDER. A NEW 6 MM AMPLATZER DUCT OCCLUDER AND TORQVUE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609688 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  ON AN UNKNOWN DATE, DURING THE PROCEDURE A 9-PDA-006 TOOK ON A UNSPECIFIED SHAPE. THE DEVICE WAS REPLACED AND PROCEDURE COMPLETED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10842870 ↗
• MalfunctionMar 10, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 A DUCTUS CLOSURE WAS PERFORMED WITH THE REFERENCE DEVICE (B)(4) OF THE BATCH: 7176841 IN A 4.7 MM LUNG DUCT, WITH AN INTRODUCER OF THE REFERENCE (B)(4) OF THE BATCH: 7022729. ACCORDING TO CLOSING INSTRUCTIONS. AT THE TIME OF DEPLOYING THE DEVICE IN THE PULMONARY PART IT WAS NOT CONFIGURED WELL AND TOOK "COBRA SHAPE", WHICH CREATES DISTRUST IN THE SPECIALIST IN ITS CONFORMATION AND DECIDES TO REMOVE IT. IT IS CHECKED ON THE TABLE TO VERIFY AND THAT IT WILL CONFORM WELL AND IT WAS OK. AGAIN IT IS DECIDED TO PASS IT AND FOR THE SECOND TIME IT TAKES THE SHAPE FORM, THAT IS, IT CHARGES, SO THE OPERATOR DECIDES TO CHANGE THE DEVICE. IN THIS CASE IT IS DECIDED TO CHANGE FOR A REFERENCE DEVICE (B)(4) OF THE LOT: 7076987 THAT GOES THROUGH THE SAME INTRODUCER ALREADY MENTIONED AND THIS DEVICE IS VERY WELL CONFORMED. THE EXTRA TIME IN THE IMPLANTATION OF THE NEW DEVICE ONLY TOOK 15 MINUTES MORE IN THE TOTAL OF THE PROCEDURE AND THE PATIENT AT ALL TIMES REMAINED STABLE AND WENT VERY WELL IN THE END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813332 ↗
• InjuryJun 4, 2019Retraction Problem; Retraction Problem

  RELATED MANUFACTURING REPORT NUMBER: 2135147-2019-00144. ON (B)(6) 2019, A 10/8MM AMPLATZER DUCT OCCLUDER (ADO) WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS ATTEMPTED TO BE POSITIONED TWICE, BUT THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY WHILE ATTACHED TO THE DELIVERY CABLE. THE DEVICE WAS ATTEMPTED TO BE RE-SHEATHED, BUT THE TIP OF THE DELIVERY SYSTEM WAS INVAGINATED PREVENTING A SUCCESSFUL RECAPTURE. THE DEVICE WAS SURGICALLY REMOVED AND THE PATENT DUCTUS ARTERIOSUS WAS LIGATED. THE PATIENT WAS RECOVERY AND SCHEDULED TO BE DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8669057 ↗
• InjuryFeb 26, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, 8/6 AMPLATZER DUCT OCCLUDER (PDA) WAS SELECTED FOR USE AND POSITIONED AT THE PATIENT'S DEFECT, BUT DEEMED UNSUITABLE DUE TO SIZE, SO THE DEVICE WAS RESHEATHED AND REMOVED. ANOTHER 10/8 PDA AND DELIVERY SHEATH WERE SELECTED FOR IMPLANT. AFTER THE PDA WAS RE-POSITIONED THREE TIMES, ON THE THIRD ATTEMPT, THE DEVICE PREMATURELY RELEASED FROM THE CABLE AND EMBOLIZED. THE DEVICE WAS SNARED VIA THE FEMORAL ARTERY AND THE DEFECT WAS THEN SUCCESSFULLY CLOSED WITH A 6/7 MVSD. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369565 ↗
• InjurySep 24, 2018Inadequacy of Device Shape and/or Size; Failure to Advance; Inadequacy of Device Shape and/or Size; Failure to Advance

  THE 10/8MM AMPLATZER DUCT OCCLUDER (ADO) WOULD NOT ADVANCE THROUGH THE 6F AMPLATZER TORQVUE 180 DELIVERY SYSTEM (DTV180). THE ADO WAS REMOVED AND REPLACED WITH A 10/8MM LIFETECH CERA DEVICE WHICH WAS SUCCESSFULLY ADVANCED. THE USER COMMENTED THAT THE AORTIC SIDE OF THE ADO WAS SLIGHTLY BIGGER THAN THE 10/8MM LIFETECH CERA DEVICE AND QUESTIONED IF THE ADO IN THE 9-PDA-006 PACKAGING WAS CORRECT. THE PROCEDURE WAS EXTENDED APPROXIMATELY 20-30 MINUTES DUE TO THIS EVENT. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904462 ↗
• InjurySep 24, 2018Retraction Problem; Retraction Problem

  ON (B)(6) 2018, A 6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN AN INFANT WITH A 6FR AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEVICE PREPARATION, THERE WAS NO ISSUE LOADING THE DEVICE. DURING PLACEMENT, THE USER WAS UNABLE TO RE-SHEATH THE DEVICE AS THE OCCLUDER WAS CAUGHT ON THE SHEATH. DUE TO THE FAILURE TO RE-CAPTURE THE DEVICE, THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE DEVICE WHERE THE SHEATH WAS EXCHANGED FOR A COOK SHEATH AND THE DEVICE WAS PULLED TO THE IVC AND RETRIEVED THROUGH THE COOK SHEATH. THE CASE WAS ABORTED WITHOUT CLOSURE OF THE DEFECT. THE DELIVERY SHEATH WAS INSPECTED AND OBSERVED TO BE INVAGINATED AT THE TERMINAL END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901926 ↗