Amplatzer Piccolo™ 9-PDAP-04-04-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05415067031013), received between May 20, 2020 and Mar 20, 2026 — classified as 3 deaths, 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (18 reports).

5 other recalls cover devices cleared under the same FDA submission (P020024); they may or may not involve this specific model.

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 18, 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.

• MalfunctionMar 20, 2026Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 04-04 AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 4F PICCOLO DELIVERY SYSTEM PRIOR TO IMPLANTATION, THE DEVICE WAS CHECKED TO CONFIRM THAT IT WAS PROPERLY SECURED TO THE DELIVERY CABLE. DURING THE PROCEDURE, AS THE PHYSICIAN ADVANCED THE DEVICE INTO THE PATIENT¿S AORTA SO THAT ONLY THE AORTIC DISC WAS WITHIN THE VESSEL AND BEFORE IT WAS RELEASED FROM THE SHEATH, THE DEVICE WAS OBSERVED TO HAVE BECOME DETACHED FROM THE DELIVERY CABLE. DESPITE THIS, THE PHYSICIAN WAS ABLE TO ACCURATELY UNSHEATH THE DEVICE AND POSITION IT WITHIN THE DUCT AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651793 ↗
• InjuryJan 16, 2026Migration or Expulsion of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (b)(6) 2025, A 4X4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TVLP CATHETER IN A PATENT DUCTUS ARTERIOSUS (PDA) OCCLUSION PROCEDURE. THE DIMENSIONS OF THE DEFECT WERE MEASURED AS 4.1 MM AT THE AORTA, 2.7 MM AT THE PULMONARY END, AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED USING ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY. DURING THE PROCEDURE, ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE UTILIZED AS IMAGING MODALITIES. AT THE TIME OF RELEASE, THE TEAM ENCOUNTERED DIFFICULTY, NOTING THAT THE DEVICE APPEARED TO BE TIGHTLY ATTACHED TO THE SCREW, WHICH RESULTED IN THE DEVICE TWISTING ALONG ITS AXIS. CONSEQUENTLY, ITS POSITION WAS ALTERED WITHIN THE HEART, LEADING TO EMBOLIZATION AFTER RELEASE. THE MIGRATION/EMBOLIZATION WAS IDENTIFIED THROUGH ANGIOGRAPHY. THE DEVICE COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION WAS DIFFICULTY RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN SHAFT. A STABILITY CHECK WAS PERFORMED, AND NO LEAK WAS DETECTED AROUND THE LOBE OF THE DEVICE DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY RHYTHM C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098825 ↗
• InjuryJan 12, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, UPON RELEASING THE DEVICE, IT WAS NOTED THAT THE DEVICE EMBOLIZED INTO THE MAIN PULMONARY ARTERY. THE DEVICE WAS COMPLETED USING A 5MM X 2MM AMPLATZER PICCOLO 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 24038244 ↗
• InjuryJan 2, 2026Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED (B)(6) 2025, A 4X4 AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F TVLP CATHETER. DURING THE PROCEDURE, THE DEFECT WAS MEASURED TO BE 4.1 MM AT THE AORTA, 2.7 MM AT THE PULMONARY END, AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED USING ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY, WHICH WERE ALSO THE IMAGING MODALITIES UTILIZED DURING THE PROCEDURE. THE MIGRATION OF THE DEVICE WAS IDENTIFIED THROUGH ANGIOGRAPHY. IT WAS NOTED THAT THE DEVICE COMPLETELY DISLODGED FROM THE INTENDED IMPLANT SITE. ACCORDING TO THE IMPLANTER, THE CAUSE OF EMBOLIZATION WAS ATTRIBUTED TO DIFFICULTY IN RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN AXIS. THE EMBOLIZATION WAS RECOGNIZED DURING THE PROCEDURE. THERE WERE NO RHYTHM CHANGES AND NO LEAK DETECTED AROUND THE LOBE OF THE DEVICE DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SIGNS OR SYMPTOMS SUCH AS ARRHYTHMIA, VALVE INTERACTION, OR HEMODYNAMIC INSTABILITY. THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE, SUCH AS MULTIPLE RECAPTURES OR REPOSITIONING. TO ADDRESS THE EMBOLIZATION, A PERCUTANEOUS RECAPTURE ATTEMPT WITH A SNARE WAS PERFORMED. THE EMBOLIZED D

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950589 ↗
• InjuryDec 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 4F AMPLATZER TVLP DELIVERY SYSTEM. THE DIMENSIONS OF THE DEFECT WERE 4.1 MM (AORTA), 2.7 MM (PULMONARY), AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED BY ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY. DURING THE PROCEDURE IT WAS NOTED THAT THE OCCLUDER EMBOLIZED. ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE USED DURING THE PROCEDURE, AND ANGIOGRAPHY IDENTIFIED THE MIGRATION/EMBOLIZATION. THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION WAS DIFFICULTY IN RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN AXIS. IT BECAME KNOWN THAT THE DEVICE HAD EMBOLIZED DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE A RHYTHM CHANGE, AND NO LEAK WAS DETECTED AROUND THE LOBE OF THE DEVICE. AN ATTEMPTED PERCUTANEOUS RETRIEVAL WITH SNARE WAS PERFORMED TO ADDRESS THE EMBOLIZATION. THE EMBOLIZED DEVICE CAUSED A PARTIAL OR COMPLETE OBSTRUCTION OF BLOOD FLOW AND TRAVELED TO THE DISTAL BRANCH OF THE RIGHT PULMONARY ARTERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881544 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 04-04MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE. THEREFORE, THE DEFORMED DEVICE WAS RETRIEVED BACK. 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 WAS REFERRED FOR SURGERY TO COMPLETE THE PROCEDURE. 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 23731473 ↗
• InjuryOct 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (DS). THE PHYSICIAN SELECTED THE 4MM X 4MM AMPLATZER PICCOLO OCCLUDER DUE TO THE MORPHOLOGY OF DUCT WITH CONSIDERABLE WIDTH OF DUCT WITH SHARP RESTRICTION AT/NEAR PA OSTIUM. THE PATIENT WAS 28 WEEK TIME OF PROCEDURE BORN AT 24 WEEKS GESTATION, HAD A WEIGHT OF 882G, AND HAD THE FOLLOWING PDA DIMENSIONS: MINIMAL DIAMETER OF 2.1MM, DIAMETER AT AORTIC AMPULLA OF 4.2MM, LENGTH OF 9.2MM. FOLLOWING PLACEMENT OF PICCOLO DEVICE INTRADUCTAL AT VERY PROXIMAL RESTRICTION OF 2.1MM WITH WAIST PLACED AT RESTRICTION POINT. IN NORMAL FASHION, THE PHYSICIAN ATTEMPTED TO PERFORM AN ANGIOGRAM THROUGH THE DS. THE PHYSICIAN WAS UNABLE TO DE-AIR THE TUOHY. DURING EACH ATTEMPT TO PULL BLOOD BACK INTO SYRINGE CONTAINING CONTRAST, BLOOD WITH SIGNIFICANT BUBBLES WERE NOTED IN THE TUOHY. A SECOND TUOHY WAS ATTACHED TO THE CATHETER, BUT MORE BUBBLES WHERE NOTED ON NEGATIVE DRAW WITH CONTRAST SYRINGE. THE PHYSICIAN STATED THEY WERE UNABLE TO PERFORM THE ANGIOGRAM DUE TO THE AIR LEAK. THE DECISION MADE TO DEPLOY THE PICCOLO DEVICE SOLELY BASED ON THE ECHO ASSESSMENT POST PLACE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20408727 ↗
• InjuryMar 20, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946294 ↗
• InjuryJun 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8136093) WAS CHOSEN FOR IMPLANT IN A 5 WEEK OLD, 1.05 KG PATIENT TO CLOSE A PATENT DUCTUS ARTERIOSUS. DURING PROCEDURE, THE DEVICE WAS NOT ABLE TO BE RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8264036). THE SECOND DEVICE WAS PLACED IN THE DUCT. ONCE THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE, THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY AND WAS NOT ABLE TO BE RETRIEVED. THE PATIENT WAS TAKEN TO OPEN HEART SURGERY TO REMOVE THE DEVICE. THE PATIENT STATUS WAS REPORTED AS RECOVERING.

  Patient problems: Obstruction/Occlusion; Pulmonary Embolism

  MAUDE report 17131266 ↗
• InjuryMay 22, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A PATIENT WITH THE FOLLOWING MEASUREMENT: 3.1 MM IN DIAMETER ON THE AORTIC END AND 2.5 MM ON THE PULMONARY ATRESIA (PA) END, WITH A LENGTH OF 7MM.. POST PROCEDURE, AFTER LEAVING PROCEDURE ROOM DEVICE MIGRATED AND CAUSED AORTIC OBSTRUCTION WITH 2.1 M/S GRADIENT. THE INFANT WAS MANAGED WITH PLACEMENT OF A STENT IN THE AORTA AND IS DOING WELL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16976499 ↗
• DeathMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON ON (B)(6) 2022, A 5MM X4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR AN IMPLANT IN A PATIENT WITH THE FOLLOWING DUCT MEASURING 3.8 MM IN DIAMETER ON THE AORTIC END AND 2.3 MM ON THE PULMONARY ARTERY (PA ) END, WITH A LENGTH OF 8.7 MM. DURING THE PROCEDURE, PICCOLO DEVICE WAS PLACED WITHOUT INCIDENT. THE ECHOCARDIOGRAM (ECHO) SHOWED NO SIGNIFICANT AORTIC OR LEFT ATRIAL PRESSURE OBSTRUCTION. FOLLOW-UP ECHO ON (B)(6) 2022 SHOWED THE DEVICE IN STABLE POSITION WITH NO FLOW ACCELERATION IN THE AORTA. ON (B)(6) 2022, THE PATIENT BEGAN TO DECOMPENSATE LATE THAT NIGHT, AN ECHOCARDIOGRAM WAS ORDERED WHICH SHOWED DEVICE MIGRATED CAUSING SEVERE OBSTRUCTION TO THE DESCENDING AORTA. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB AT THAT TIME AND THE ORIGINAL PICCOLO DEVICE WAS SNARED AND REMOVED FROM THE BODY WITHOUT DIFFICULTY. A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS THEN PLACED AS A REPLACEMENT WITHOUT INCIDENT. FOLLOW-UP ECHOCARDIOGRAM THAT EVENING AND ALL SUBSEQUENT STUDIES (4/13, 4/18, 4/23 AND 4/24) SHOWED THE DEVICE IN STABLE POSITION WITH NO OBSTRUCTION TO THE AORTA OR LEFT ATRIAL PRESSURE. THE PATIENT SUFFERED RENAL FAILURE AND LATER PASSED AWAY. THE CAUSE

  Patient problems: Renal Failure

  MAUDE report 16975116 ↗
• InjuryNov 22, 2022Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Premature Separation; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT'S PATENT DUCTUS ARTERIOSUS (PDA) HAD THE FOLLOWING DIMENSIONS; LENGTH OF 9MM AND MINIMAL DUCTUS DIAMETER OF 3.5MM. IT WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND FLUOROSCOPY, THAT AFTER IMPLANT THE OCCLUDER EMBOLIZED INTO THE PATIENT'S RIGHT PULMONARY ARTERY INTRA-PROCEDURALLY. THE DECISION WAS MADE TO EMERGENTLY SNARE THE 4MM X 4MM AMPLATZER PICCOLO OCCLUDER. THE 4MM X 4MM AMPLATZER PICCOLO OCCLUDER HAD BEEN SIZED USING FLUOROSCOPIC EXAMINATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THIS EVENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE 4MM X 4MM AMPLATZER PICCOLO OCCLUDER OR PROCEDURE. THE CAUSE OF THE OCCLUDER EMBOLIZING WAS DUE TO THE OCCLUDER BECOMING PREMATURELY UNSCREWED/RELEASED FROM THE DELIVERY CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848815 ↗
• InjuryNov 1, 2022Migration 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) 2022, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT INTO A PATENT DUCTUS ARTERIOSUS (PDA) USING AN AMPLATZER TORQVUE LP DELIVERY SYSTEM. THE DIMENSIONS OF THE DEFECT WERE MEASURED AS 3.6MM X 4.9MM X 12.2MM. THE SIZING OF THE PICCOLO OCCLUDER WAS DETERMINED VIA ANGIOGRAPHY WITH MEASUREMENT ON THE PHILLIPS SYSTEM. MULTIPLE CATHETERS AND WIRES WERE REQUIRED TO ACCESS THE PDA, BUT NONE OF THOSE DEVICES USED FOR INITIALLY CROSSING THE DEFECT WERE ABBOTT PRODUCTS. THE OCCLUDER WAS IMPLANTED INTO THE PDA, AND UPON RELEASE FROM THE CABLE, THE DEVICE EMBOLIZED INTO THE RIGHT PULMONARY ARTERY (RPA). THIS WAS DETERMINED BY VISUALIZATION OF THE DEVICE IN THE RPA UNDER FLUOROSCOPY. THE DEVICE WAS RETRIEVED USING A TRANSCATHETER SNARE AND REMOVED FROM THE PATIENT. THE OPERATOR BELIEVES THE CAUSE OF THE EMBOLIZATION WAS INCORRECT SIZING OF THE DEVICE AND POSITION. THE PATIENT WAS REPORTED AS STABLE UPON DISCHARGE FROM THE HOSPITAL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15712682 ↗
• DeathOct 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. AFTER IMPLANT OF THE DEVICE BUT DURING THE PROCEDURE, THAT THE PATIENT SUFFERED CARDIAC ARREST. CHEST COMPRESSIONS WERE INITIATED. ULTIMATELY, THE PATIENT WAS PRONOUNCED DECEASED. THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE. IT WAS THOUGHT THAT THE PROXIMAL DISC CAUSED A COARCTATION INTO THE AORTA. THE DIMENSIONS OF THE PATIENT'S PATENT DUCTUS ARTERIOSUS WAS REPORTED AS AORTIC AMPULLA- 5.4MM, MIDDLE OF DUCT-2.5MM, NARROWEST PORTION-1.5MM, LENGTH-10.5MM. IT WAS NOTED THAT PRIOR TO THE PROCEDURE THE PATIENT WAS NOTED IN STABLE CONDITION.

  Patient problems: Cardiac Arrest

  MAUDE report 15695144 ↗
• InjurySep 9, 2022Migration 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) 2022, A 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 5-WEEK OLD, 1.8 KG PATIENT. DURING PROCEDURE, THE DEVICE WAS IMPLANTED. A FEW MINUTES AFTER THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE, THE DEVICE EMBOLIZED. THE DEVICE WAS THEN SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393612 ↗
• InjuryJul 8, 2022Migration 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) 2022, A 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 4KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER OF 2MM, DIAMETER AT AORTIC AMPULLA OF 4.2MM, AND LENGTH OF 4.6MM. THE DEVICE WAS SIZED USING ANGIOGRAPHY. DURING THE PROCEDURE, THE DEVICE HAD EXTRADUCTAL PLACEMENT, AND IT WAS REPOSITIONED TO AN INTRADUCTAL POSITION. THE DEVICE WAS RELEASED AND EMBOLIZED INTO A BRANCH OF THE RIGHT PULMONARY ARTERY. THE DEVICE WAS NOT ABLE TO BE SNARED, AND THE PATIENT WAS THEN TRANSPORTED TO A DIFFERENT HOSPITAL TO REMOVE THE DEVICE. THEN, A 5MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT STATUS WAS REPORTED AS STABLE, AND THE PATIENT HAS SINCE BEEN DISCHARGED WITH NO PATIENT CONSEQUENCES. THE IMPLANTER BELIEVED THAT THE CAUSE OF THE EMBOLIZATION WAS THAT THE DEVICE WAS TOO SMALL FOR THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961431 ↗
• InjuryFeb 4, 2022Obstruction of Flow; Migration; Obstruction of Flow; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 44 DAY OLD, 1.2 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER 2.8MM, PDA DIAMETER AT AORTIC AMPULLA 3.2MM, PDA LENGTH 13MM. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH ACCURATE INTRADUCTAL PLACEMENT AND NO IMPINGEMENT OF AORTIC FLOW. ON (B)(6) 2022, IT WAS REVEALED ON ECHOCARDIOGRAPHY THAT THE DEVICE HAD MIGRATED AND WAS PROTRUDING INTO THE DESCENDING AORTA WITH PROMINENT GRADIENT MEASUREMENTS. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE FROM THE PULMONARY ARTERY (PA) BUT WAS UNSUCCESSFUL. THE DEVICE WAS REQUIRED TO BE RETRIEVED SURGICALLY, AND THE PATIENT'S PDA WAS SURGICALLY LIGATED. THE PATIENT RECOVERED FROM SURGERY AND WAS EXTUBATED WITHIN 72 HOURS. THERE WAS NO IMPLICATION OF PERMANENT IMPAIRMENT OR DAMAGE, AND INVERSELY, THE TEAM FEELS CLOSURE OF THE PDA WAS HELPFUL IN PULMONARY FUNCTION. THE PATIENT STATUS IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13457579 ↗
• InjuryNov 23, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 4/4 AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A (B)(6) OLD (B)(6) KG PATIENT IN THE INTRADUCTAL POSITION. ON THE MORNING OF (B)(6) 2021, IT WAS FOUND THAT THE DEVICE HAD EMBOLIZED INTO THE RIGHT PULMONARY ARTERY (RPA). THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB WHERE THE DEVICE WAS SUCCESSFULLY RETRIEVED VIA TRANSCATHETER SNARE. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 5/4 AMPLATZER DUCT OCCLUDER, HOWEVER IT WAS MIS-SIZED AS NOTED BY THE RETENTION SKIRT OBSTRUCTING AORTIC FLOW. THE DEVICE WAS REMOVED PRIOR TO RELEASE AND REPLACED WITH A 5/4 AMPLATZER PICCOLO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863582 ↗
• InjuryJul 21, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021, A 3/4 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) DAY OLD (B)(6) KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 2.1MM, PDA LENGTH OF 9MM AND DIAMETER AT AORTIC AMPULLA OF 3.7MM. DURING THE PROCEDURE THE DEVICE WAS PLACED INTRADUCTAL, BUT WAS MIS-SIZED TOO SMALL. THE DEVICE WAS REMOVED AND EXCHANGED FOR A 4/4 AMPLATZER PICCOLO OCCLUDER. THE REPLACEMENT DEVICE WAS PLACED IN AN ACCEPTABLE POSITION WITH THE SAME INITIAL DELIVERY SYSTEM (DS), BUT UPON RELEASING THE DEVICE, THE OCCLUDER SHIFTED INTO A DIFFERENT POSITION IN THE PDA. AS THERE WERE CONCERNS OF DEVICE EMBOLIZATION, THE DECISION WAS MADE TO REMOVE THE DEVICE WITH A 10MM NON-ABBOTT GOOSENECK SNARE. THE DEVICE WAS SUCCESSFULLY REMOVED AND A 4/2 AMPLATZER PICCOLO OCCLUDER WAS THEN ATTEMPTED AND SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PROCEDURE WAS NOT EXTENDED LONGER THAN IS CLINICALLY SIGNIFICANT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202384 ↗
• DeathJan 11, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A PREMATURE (B)(6) OLD, (B)(6) PATIENT UNDERWENT PATENT DUCTUS ARTERIOSUS(PDA) CLOSURE USING A 4/4 AMPLATZER PICCOLO OCCLUDER. THE PATIENT HAD THE FOLLOWING PDA DIMENSIONS: MINIMAL DIAMETER OF 3MM BY ANGIOGRAM (2.8 MM BY ECHO), MAXIMAL DIAMETER AT AORTIC AMPULLA OF 5MM AND LENGTH OF 10MM. DURING THE PROCEDURE, THE DEVICE APPEARED TO BE IN VERY GOOD POSITION WITH NO OBSTRUCTION OF THE LEFT PULMONARY ARTERY(LPA) DESCENDING AORTA AND NO RESIDUAL SHUNTING. THE DEVICE WAS SUBSEQUENTLY RELEASED ON CINE GUIDANCE AND INITIALLY WAS IN VERY STABLE POSITION. FOLLOW-UP ECHO DEMONSTRATED IMMEDIATE EMBOLIZATION OF THE DEVICE INTO THE RIGHT PULMONARY ARTERY(RPA) SECONDS FOLLOWING RELEASE. THE PHYSICIAN RETRIEVED THE DEVICE WITH A 4 FRENCH TERUMO GLIDE CATHETER AND A 7 MM SNARE, BUT THE DEVICE WAS UNABLE TO BE RETRIEVED INTO THE 4 FRENCH TERUMO GLIDE CATHETER AND THE DEVICE RELEASED FROM THE SNARE AND EMBOLIZED INTO THE RPA AGAIN. SUBSEQUENTLY, THE PHYSICIAN USED A 4 FRENCH FLEXOR COOK SHEATH AND DIRECTED IT INTO THE RPA OVER A GUIDEWIRE, BUT THIS RESULTED IN A RPA PERFORATION WITH SUBSEQUENT FATALITY.

  Patient problems: Death; Embolism

  MAUDE report 11152172 ↗
• InjurySep 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 4-4 AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT. THE PATIENT IS (B)(6) WITH A PDA DIMENSION OF : 2.8MM AT NARROWEST, 4.6MM AT AORTIC AMPULLA, AND 13.7MM IN LENGTH. THE 4-4 PICCOLO WAS SUCCESSFULLY IMPLANTED WITH A TORQVUE LP CATHETER. THE DEVICE APPEARED STABLE WITH NO GRADIENT IN THE LEFT PULMONARY ARTERY OR AORTA UPON RELEASE. A SMALL "FLARE" SIGNAL AT THE TOP OF THE DEVICE WAS OBSERVED. 30 TO 40 MINUTES POST PROCEDURE, AN X-RAY OF THE CHEST REVEALED THAT THE DEVICE HAD EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE DEVICE WAS RETRIEVED UTILIZING A 4MM MICRO SNARE (AMPLATZ GOOSENECK SNARE SK401) VIA TRANSCATHETER METHOD FROM THE RIGHT PULMONARY ARTERY AND A 5-4 PICCOLO WAS IMPLANTED. THE PATIENT IS CURRENTLY STABLE IN THE NICU, WITH A MILD TRICUSPID REGURGITATION OBSERVED. THE TRICUSPID REGURGITATION OCCURRED AFTER THE DEVICE WAS SNARED AND REMOVED FROM THE PATIENT AND WAS LIKELY CAUSED BY THE SNARE.

  Patient problems: Embolism

  MAUDE report 10597013 ↗
• InjurySep 9, 2020Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020, A 4-4 AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT ON A (B)(6) KG PATIENT. THE PATIENT HAS THE FOLLOWING PDA DIMENSION; MINIMAL DIAMETER: 2.5MM, AMPULLA: 4MM, LENGTH:6MM AND THE DEVICE WAS PLACED INTRADUCTAL. THE DEVICE WAS RELEASED AND LOOKED IN A STABLE POSITION. ON CHEST X-RAY, IT WAS OBSERVED THAT THE DEVICE HAD EMBOLIZED TO THE PULMONARY ARTERY. THE 4-4 PICCOLO WAS SNARED AND REMOVED FROM THE PATIENT. A 5-2 PICCOLO WAS IMPLANTED INSTEAD. THE CHEST X-RAY WAS COMPLETED IN THE NICU AND THE DEVICE WAS SEEN TO BE IN A STABLE POSITION. THE PATIENT IS CURRENTLY STABLE AND RECOVERING IN THE NICU.

  Patient problems: Embolism

  MAUDE report 10507833 ↗
• InjuryMay 26, 2020Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2020, A 4-4 AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT FOR A PATENT DUCTUS ARTERIOSUS (PDA) IN A (B)(6) OLD (B)(6) FEMALE PATIENT. THE PDA HAS THE FOLLOWING DIMENSIONS: MINIMAL DIAMETER: 3.4MM, AORTIC AMPULLA DIAMETER: 4.6MM, LENGTH: 10.0MM. THE DEVICE PLACEMENT WAS INTRADUCTAL. THE DEVICE EMBOLIZED INTO THE LEFT PULMONARY ARTERY UPON RELEASE. THE DEVICE WAS RETRIEVED AND EXCHANGED WITH A 5-2 PICCOLO (LOT # 7277280). THE PATIENT IS CURRENTLY STABLE, CLINICALLY WELL, AND WEANING OFF RESPIRATORY SUPPORT.

  Patient problems: Embolism

  MAUDE report 10090221 ↗
• InjuryMay 20, 2020Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2020, A 4-4 AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT. THE (B)(6) OLD, (B)(6) PATIENT HAS THE FOLLOWING PDA DIMENSION: AO: 4.36MM, MID: 2.14MM, PULMONARY: 3.27MM, AND LENGTH: 9.33MM. THE DEVICE WAS IMPLANTED INTRADUCTAL, BUT EMBOLIZED FROM THE DUCT TO THE LEFT PULMONARY ARTERY 2 MINUTES AFTER DEPLOYMENT. THE DEVICE WAS SNARED AND REMOVED FROM THE LEFT PULMONARY ARTERY. THE DEVICE WAS EXCHANGED WITH A 5-4 PICCOLO AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS DOING WELL WITH NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: Embolism

  MAUDE report 10077674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020024. One submission often covers many models, so check the product and lot details in each record.

• Z-2192-2008 · Apr 25, 2008 · Terminated
  AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendels
• Z-0256-2007 · Oct 2, 2006 · Terminated
  Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80,
• Z-0255-2007 · Oct 2, 2006 · Terminated
  Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60,
• Z-0461-06 · Sep 6, 2005 · Terminated
  AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golde
• Z-0350-05 · Nov 23, 2004 · Terminated
  Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delive