Amplatzer Piccolo™ 9-PDAP-05-04-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05415067031044), received between Sep 17, 2019 and Jul 11, 2025 — classified as 1 death, 39 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (33 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT. THE OCCLUDER WAS SIZED AS PER THE INSTRUCTIONS FOR USE. THE DIMENSION OF THE DEFECT WAS 3.5MM. THERE WAS NO RHYTHM CHANGE DURING PROCEDURE. A STABILITY CHECK WAS PERFORMED DURING PROCEDURE. THERE WAS NO LEAK DETECTED AROUND THE LOBE OF THE DEVICE DURING THE PROCEDURE. THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE, SUCH AS MULTIPLE RECAPTURES/REPOSITIONING. POST-PROCEDURE IT WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM, THAT THE OCCLUDER EMBOLIZED. THE OCCLUDER EMBOLIZED TO THE LEFT PULMONARY ARTERY. THE EMBOLIZED OCCLUDER CAUSED A PARTIAL OBSTRUCTION/BLOCKAGE OF BLOOD FLOW. THE DECISION WAS MADE TO PERFORM PERCUTANEOUS RETRIEVAL OF THE OCCLUDER. THE PATIENT DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THIS EVENT. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATION DUE TO THIS EVENT. THE CAUSE OF THE EMBOLIZATION IS ATTRIBUTED TO THE PATIENT BEING LARGER. THE PATIENT WAS NOTED TO HAVE RECOVERED AT THE TIME OF REPORT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22482298 ↗
• MalfunctionMar 6, 2025Device Difficult to Setup or Prepare; Separation Problem; Device Difficult to Setup or Prepare; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING THE ATTEMPT TO RELEASE THE OCCLUDER, DELIVERY CABLE AND PLASTIC VISE WERE INOPERABLE IN THE DELIVERY SYSTEM. WHEN THE PHYSICIAN ATTEMPTED TO UNSCREW THE FORE MENTIONED PICCOLO FROM THE TORQVUE SYSTEM THE PLASTIC VISE JUST SLIDE AROUND THE CABLE. THE PHYSICIAN TRIED TO RE-TIGHTEN THE VISE TO THE CABLE AND THE SET SCREW WAS HUBBED OUT AND WOULD STILL NOT CONTACT THE CABLE. AFTER INSPECTION OF THE CABLE IT WAS NOTED, THE VISE WOULD JUST SLIDE OFF THE CABLE AND NOT MAKE CONTACT WITH THE VISE SET SCREW FULLY TIGHTENED DOWN. THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE PHYSICIAN USED A GUIDEWIRE TORQUER DEVICE TO UNSCREW THE DEVICE FROM THE CABLE AND IMPLANTED THE PICCOLO OCCLUDER. THERE WAS SOME DELAY IN THE PATIENT CARE, ONLY A FEW MINUTES BUT THE ABY TOLERATED THAT PORTION WELL. THE PATIENT WAS REPORTED RECOVERING IN NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536091 ↗
• MalfunctionJan 9, 2025Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120612 ↗
• MalfunctionDec 4, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 FOR A PATIENT WEIGHED AT 2KG WITH A MINIMAL DUCTUS DIAMETER OF 3.5MM AND A DUCTUS LENGTH OF 13MM, USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. DURING IMPLANT THE DEVICE TOOK ON A SNAKE SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REPLACED WITH A NEW 5MM X 4MM AMPLATZER PICCOLO 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 20844525 ↗
• InjuryOct 29, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT FOR A 1.2KG, 4-WEEK-OLD PATIENT WITH PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS OF 3.4MM MINIMAL DIAMETER, 3.9MM DIAMETER AT AORTIC AMPULLA, AND 9.7MM LENGTH. PDA MEASUREMENTS WERE DETERMINED VIA ANGIOGRAPHY. ECHOCARDIOGRAPHY AND ANGIOGRAPHY IMAGING WERE USED DURING THE CASE. ACCESS WAS VENOUS. THE DEVICE WAS PLACED INTRADUCTALLY. THE PULSE CHECKLIST WAS USED, AND A STABILITY CHECK WAS PERFORMED. UPON RELEASE, THE DEVICE MIGRATED TOWARD THE LEFT PULMONARY ARTERY. THE DEVICE WAS RETRIEVED VIA PERCUTANEOUS REMOVAL, AND A 5MM NON-ABBOTT PLUG WAS CHOSEN AND PLACED. THE IMPLANTED BELIEVED THAT THE DEVICE MIGRATED BECAUSE IT WAS TOO SMALL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563536 ↗
• MalfunctionAug 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MMX4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING IMPLANT, 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 DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. A NEW 4MMX2MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919189 ↗
• InjuryMar 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM FOR A 12KG PATIENT. THE PDA MINIMAL DIAMETER WAS 2MM, AND THE DIAMETER AT AORTIC AMPULLA WAS 7-8MM. THE SIZING OF THE DEVICE WAS DETERMINED BY ANGIOGRAPHY. THE DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2024, A FOLLOW UP IMAGING WAS CONDUCTED, AND SHOWED THE OCCLUDER WAS DISLOCATED COMPLETELY FROM THE IMPLANT STATE. THE PHYSICIAN MENTIONED INAPPROPRIATE DEVICE SIZE WAS THE CAUSE OF EMBOLIZATION. THE DEVICE WAS REMOVED BY A MINIMALLY INVASIVE PROCEDURE BY USING A SNARE. THE RETRIEVAL OF THE DEVICE WAS CONSIDERED AS A EMERGENCY PROCEDURE. A NEW 4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978676 ↗
• MalfunctionJan 8, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023. 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 IN 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 PROCEDURE WAS CANCELLED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467607 ↗
• InjuryNov 13, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE ARTICLE, "LEFT PULMONARY ARTERY OCCLUSION FOLLOWING DEVICE CLOSURE OF PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 30-DAY-OLD, 1160G, MALE PATIENT WITH COMORBIDITIES NECROTIZING ENTEROCOLITIS (NEC) WITH BOWEL RESECTION, ILEOSTOMY, VENTILATOR DEPENDENCE, BRONCHOPULMONARY DYSPLASIA (BPD), AND POOR NUTRITION. IT WAS REPORTED ON AN UNKNOWN DATE A 5-4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT TO OCCLUDER A PATENT DUCTUS ARTERIOSUS (PDA) WITH THE FOLLOWING DIMENSIONS: NARROWEST DIAMETER = 3.5MM, LARGEST DIAMETER = 4.5MM, AND LENGTH = 11.3MM. AFTER INITIAL IMPLANT, IT WAS NOTED THE DEVICE EMBOLIZED TO THE LEFT PULMONARY ARTERY (LPA). A DECISION WAS MADE TO RETRIEVE THE DEVICE AND IT WAS REPOSITIONED AND IMPLANTED CLOSER TO THE AORTIC END OF THE PDA. IT WAS THEN REPORTED 9 WEEKS LATER ON AN UNKNOWN DATE, A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED A SUPRASYSTEMIC RIGHT VENTRICLE AND NO FLOW TO THE LPA. A DECISION WAS MADE TO PERFORM SURGICAL REVASCULARIZATION VIA PULMONARY ARTERIOPLASTY WHERE IT WAS NOTED THE 5-4MM AMPLATZER PICCOLO OCCLUDER'S PROXIMAL DISC WAS INTRADUCTAL WITH THE LPA BELOW AND COMPLETELY OBSTRUCTING

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 18120745 ↗
• InjuryNov 9, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE ARTICLE, "LEFT PULMONARY ARTERY OCCLUSION FOLLOWING DEVICE CLOSURE OF PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 25-DAY-OLD, 975G, MALE PATIENT WITH COMORBIDITIES PERSISTENT METABOLIC ACIDOSIS, VENTILATOR DEPENDENCE, TWIN DIED DUE TO NECROTIZING ENTEROCOLITIS (NEC) WITH LARGE PATENT DUCTUS ARTERIOSUS (PDA), BRONCHOPULMONARY DYSPLASIA (BPD), AND POOR NUTRITION. IT WAS REPORTED ON AN UNKNOWN DATE A 5-4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT TO OCCLUDER A PDA WITH THE FOLLOWING DIMENSIONS: NARROWEST DIAMETER = 3.3MM, LARGEST DIAMETER = 4.3MM, AND LENGTH = 12MM. DURING PROCEDURE, IT WAS REPORTED DEVICE IMPLANT WAS STRAIGHTFORWARD, AND POST RELEASE TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED IT TO BE WELL SEATED WITH ONLY SLIGHT LEFT PULMONARY ARTERY (LPA) TURBULENCE CAUSED BY THE PROXIMAL DISC. IT WAS THEN REPORTED 12 WEEKS POST-PROCEDURE, TTE SHOWED AN INCREASE IN MAXIMAL GRADIENT VELOCITY WITH MINIMAL FLOW BY COLOR DOPPLER. THE PATIENT ADDITIONALLY REQUIRED RESPIRATORY SUPPORT. AN ANGIOGRAPHY REVEALED SEVERE OBSTRUCTION TO THE LPA CAUSED BY THE PROXIMAL DISC. A DECISION WAS MADE TO ATTEMPT PERCUTANEOUS REVASC

  Patient problems: Dyspnea; Obstruction/Occlusion

  MAUDE report 18104423 ↗
• InjuryNov 8, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM X 2MM AMPLATZER PICCOLO DEVICE WAS CHOSEN FOR IMPLANTATION INTO A 7 WEEK OLD 1.4 KILOGRAM PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER 4.2 MM, LENGTH OF 8 MM, AND DIAMETER AT AORTIC AMPULLA OF 5 MM. SIZING WAS DETERMINED VIA ANGIOGRAM. THE 5MM X 2MM WAS ADVANCING TO THE PDA, BUT IT SEEMED UNSTABLE DUE TO MIS-SIZING SO A 5MM X 4MM AMPLATZER PICCOLO WAS ATTEMPTED TO BE IMPLANTED. THE DEVICE WAS IMPLANTED AND STABLE ON FLUOROSCOPY IMAGING, BUT BY THE TIME ECHOCARDIOGRAPHIC IMAGING WAS BROUGHT UP TO CONFIRM POSITIONING, THE DEVICE HAD COMPLETELY DISLODGED AND TRAVELED TO THE LEFT PULMONARY ARTERY. THERE WAS NO OBSTRUCTION OF BLOOD FLOW. THE DEVICE WAS SNARED AND REMOVED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO PATIENT CONSEQUENCES. NO FURTHER DEVICES WERE ATTEMPTED AND THE PATIENT UNDERWENT SURGICAL LIGATION OF THE PATENT DUCTUS ARTERIOSUS ON (B)(6) 2023. THE PHYSICIAN THOUGHT THE PATIENT'S PDA WAS TOO LARGE TO BE CLOSED WITH AVAILABLE PICCOLO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 18092462 ↗
• InjuryOct 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT FOR A 2 WEEK OLD, 1.2KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER OF 3.4MM, DIAMETER AT AORTIC AMPULLA OF 3.6MM, AND DUCTAL LENGTH OF 12MM. A SERIES OF FOLLOW UP ECHOCARDIOGRAMS SHOWED A STABLE LEFT PULMONARY ARTERY (LPA) GRADIENT OF APPROXIMATELY 10/12MMHG (15-17M/SEC). ON (B)(6) 2023, THE PATIENT HAD AN OUT-PATIENT CLINIC VISIT, AND AN ECHOCARDIOGRAM DEMONSTRATED SEVERE LPA OBSTRUCTION. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE PATIENT WAS REFERRED FOR FURTHER INTERVENTION. ON (B)(6) 2023, A HEART CATHETER WAS PERFORMED, WHICH SHOWED THAT THE DEVICE WAS IN THE DUCTUS AND AT THE MOUTH OF THE LEFT PULMONARY ARTERY. THE PHYSICIAN WAS UNABLE TO GET INTO THE LPA WITH A WIRE OR CATHETER. SURGERY WAS THEN SCHEDULED FOR LPA ARTERIOPLASTY. ON (B)(6) 2023, THE PATIENT HAD RHINOVIRUS WITH COUGH AND NASAL CONGESTION, SO THE SURGERY WAS POSTPONED. ON (B)(6) 2023, THE PROXIMAL PORTION OF THE DEVICE WAS REMOVED. IN THE OPERATING ROOM, IT WAS BELIEVED BY THE PHYSICIAN THAT THE DEVICE MAY HAVE MIGRATED. THE PATIENT WAS HOSPITALIZED. THE PATIENT STATUS W

  Patient problems: Obstruction/Occlusion

  MAUDE report 17860494 ↗
• InjurySep 18, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 05 AUGUST 2022, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8421938) WAS CHOSEN FOR IMPLANT, USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM FOR 30 DAYS OLD, 1.2 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DIAMETER OF 3.5MM, LENGTH OF 11.3MM, AND DIAMETER AT AORTIC AMPULLA OF 4.5MM. IT WAS INDICATED THAT THE PHYSICIAN FELT MEASUREMENTS AND WEIGHT WERE "BORDERLINE" BETWEEN DEVICE CHOICES. PER PHYSICIAN DOWNSIZING WAS NOT AN OPTION. ORIGINAL DEPLOYMENT HAD IMMEDIATE EMBOLIZATION OF THIS DEVICE THAT WAS CONFIRMED IN FLUOROSCOPY, WHICH WAS RETRIEVED VIA 10MM GOOSENECK SNARE, AND REMOVED FROM THE PATIENT. A REPLACEMENT 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8160390) WAS SUCCESSFULLY IMPLANTED WITH SATISFACTORY RESULT PER PHYSICIAN. ON (B)(6)2022, ECHOCARDIOGRAM SHOWED OBSTRUCTION ON THE LEFT PULMONARY ARTERY (LPA) DUE TO PATIENT ANATOMY. THE PATIENT EXPERIENCED DIFFICULTY BREATHING, REQUIRING RESPIRATORY SUPPORT. THE PATIENT UNDERWENT MEDICAL INTERVENTION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS INTO THE LPA. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL LPA ANGIOPLASTY. THE PATIENT WAS DISCHARGED AND REPORTED TO BE

  Patient problems: Obstruction/Occlusion

  MAUDE report 17770243 ↗
• InjurySep 11, 2023Migration 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) 2023, A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 4.3KG, 46 DAY OLD PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 3.1-3.2MM, PDA LENGTH OF 7-9MM, PDA DIAMETER AT THE AORTIC AMPULLA 7.88MM. THE DELIVERY SYSTEM WAS AN UNKNOWN ABBOTT DELIVERY SYSTEM. GIVEN THE LARGE AORTIC AMPULLA, THE DECISION WAS MADE TO USE A 5/4 PICCOLO OCCLUDER INSTEAD OF THE RECOMMENDED 5/6 PICCOLO OCCLUDER. IT WAS DECIDED TO USE A SHORTER DEVICE TO ALLOW APPOSITION OF THE DISTAL DISC. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS USED DURING PROCEDURE. THE DEVICE WAS DEPLOYED A COUPLE OF TIMES. ON TTE AND FLUOROSCOPY, THERE WAS NO IMPINGEMENT ON THE LEFT PULMONARY ARTERY (LPA) OR THE AORTA, AND THERE WAS NO RESIDUAL SHUNT THROUGH THE DEVICE. THE PICCOLO PULSE CHECKLIST WAS UTILIZED. A PUSH PULL TEST WAS PERFORMED, AND THERE WAS NO MOVEMENT OF THE DEVICE. THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE. THE PATIENT HAD A SUBSEQUENT PROCEDURE FOR ESOPHAGEAL DILATION. PRIOR TO DILATION, THE DEVICE WAS STILL IN PLACE. AFTER THE ESOPHAGEAL DILATION WAS PERFORMED, THE PATIENT NEEDED TO BE REINTUBATED. IT WAS NOTED THAT

  Patient problems: Hypoxia; Obstruction/Occlusion

  MAUDE report 17720802 ↗
• InjuryAug 30, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8421938) WAS CHOSEN FOR IMPLANT, USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM FOR 30 DAYS OLD, 1.2 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DIAMETER OF 3.5MM, LENGTH OF 11.3MM, AND DIAMETER AT AORTIC AMPULLA OF 4.5MM. IT WAS INDICATED THAT THE PHYSICIAN FELT MEASUREMENTS AND WEIGHT WERE "BORDERLINE" BETWEEN DEVICE CHOICES. PER PHYSICIAN DOWNSIZING WAS NOT AN OPTION. ORIGINAL DEPLOYMENT HAD IMMEDIATE EMBOLIZATION OF THIS DEVICE THAT WAS CONFIRMED IN FLUOROSCOPY, WHICH WAS RETRIEVED VIA 10MM GOOSENECK SNARE, AND REMOVED FROM THE PATIENT. A REPLACEMENT 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER (LOT 8160390) WAS SUCCESSFULLY IMPLANTED WITH SATISFACTORY RESULT PER PHYSICIAN. ON (B)(6) 2022, ECHOCARDIOGRAM SHOWED OBSTRUCTION ON THE LEFT PULMONARY ARTERY (LPA) DUE TO PATIENT ANATOMY. THE PATIENT EXPERIENCED DIFFICULTY BREATHING, REQUIRING RESPIRATORY SUPPORT. THE PATIENT UNDERWENT MEDICAL INTERVENTION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS INTO THE LPA. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL LPA ANGIOPLASTY. THE PATIENT WAS DISCHARGED AND REPORTED TO BE S

  Patient problems: Dyspnea; Obstruction/Occlusion

  MAUDE report 17652204 ↗
• InjuryAug 30, 2023Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED INTRADUCTAL, USING 04F AMPLATZER TORQVUE LP DELIVERY SYSTEM (TVLP) FOR 25 DAY OLD, 0.98KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DIAMETER OF 3.3MM, LENGTH OF 11.6MM, AND DIAMETER AT AORTIC AMPULLA OF 4.3MM. IT WAS NOTED THAT AFTER IMPLANT, THERE WAS A SLIGHT LEFT PULMONARY ARTERY (LPA) TURBULENCE CAUSED BY THE PROXIMAL DISC; HOWEVER, IN THE PHYSICIAN¿S OPINION, THIS WAS OF LITTLE CONCERN. ON (B)(6) 2022, ECHOCARDIOGRAM SHOWED THAT THE PROXIMAL DISK MIGRATED OUT OF DUCTUS, FLATTENED AGAINST PULMONARY ARTERY AND BLOCKING THE LPA. THE PATIENT EXPERIENCED DIFFICULTY BREATHING, REQUIRING RESPIRATORY BIPAP SUPPORT. THE PATIENT UNDERWENT MEDICAL INTERVENTION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS INTO THE LPA. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL LPA ANGIOPLASTY. ONLY A PORTION OF THE PROXIMAL DISC WHICH WAS OBSTRUCTING THE LPA OPENING WAS EXCISED BY THE SURGEON. THE PATIENT WAS DISCHARGED AND REPORTED TO BE STABLE.

  Patient problems: Dyspnea; Obstruction/Occlusion

  MAUDE report 17652155 ↗
• InjuryJun 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 17 MAY 2023, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER (LOT#8428423) WAS CHOSEN FOR IMPLANTATION INTO 1 MONTH OLD, 3.1KG NEWBORN UTILIZING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER FOR A PATENT DUCTUS ARTERIOSUS CLOSURE (PDA) PROCEDURE. THE PDA DIMENSIONS WERE 5.4 MM AT THE AORTIC AMPULLA, 5.1 MM LENGTH OF THE PDA, AND 2.1 MM MINIMAL DIAMETER OF THE PDA. THE DEVICE WAS PLACED WITH ONE DISC PLACED EXTRADUCTAL ON THE PULMONARY ARTERY SIDE AND ONE DISC PLACED INTRADUCTAL ON THE AORTIC SIDE. THE PLACEMENT OF THE DEVICE WAS CONFIRMED BY IMAGING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. LATER THE SAME DAY, ON (B)(6) 2023, THE PICCOLO DEVICE WAS CONFIRMED VIA X-RAY TO HAVE EMBOLIZED FROM IT'S POSITION. THE NEXT DAY, ON (B)(6) 2023, A CATHETERIZATION PROCEDURE WAS PERFORMED TO RETRIEVE THE PICCOLO DEVICE WHICH HAD BECOME CAUGHT IN A BRANCH OF THE PULMONARY ARTERY (PA) IN THE LOWER BACK RIGHT LUNG. ATTEMPTS TO RETRIEVE THE PICCOLO WERE UNSUCCESSFUL FOR MULTIPLE HOURS. AT ONE POINT THE PICCOLO WAS CAUGHT, BUT THEN WAS DROPPED AGAIN IN TO THE RIGHT PA PERIPHERY. IMAGING SHOWED THAT THERE WAS NO BL

  Patient problems: Obstruction/Occlusion; Pulmonary Embolism

  MAUDE report 17108511 ↗
• InjuryMay 22, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6)2023, 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) 2023 SHOWED THE DEVICE IN STABLE POSITION WITH NO FLOW ACCELERATION IN THE AORTA. ON (B)(6) 2023, 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 OF

  Patient problems: Obstruction/Occlusion

  MAUDE report 16975152 ↗
• DeathMay 12, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT FOR A 1 MONTH OLD, 1.3 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER 3MM, DIAMETER AT AORTIC AMPULLA 3.8-4.0MM, AND LENGTH OF 12MM. THE DELIVERY SHEATH WAS A 4F AMPLATZER TORQVUE LP CATHETER. THE PDA CLOSURE WAS PERFORMED FROM THE LEFT INTERNAL JUGULAR DUE TO INTERRUPTED INFERIOR VENA CAVA ACCESS. THE 5/4 PICCOLO OCCLUDER WAS PLACED IN AN INTRADUCTAL POSITION. ON TRANSTHORACIC ECHOCARDIOGRAM, THE AORTA AND LEFT PULMONARY ARTERY WERE UNOBSTRUCTED. ON (B)(6) 2023, IT WAS REPORTED THAT THE REPORTED THAT THE DEVICE HAD MIGRATED TO THE AORTA. THE PATIENT EXPIRED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS NOTED THAT THERE WAS DIFFICULTY IMPLANTING THE DEVICE. THE CAUSE OF DEATH WAS NOTED AS REDUCED SYSTEMIC FLOW IN AORTA.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 16920363 ↗
• InjuryApr 25, 2023Migration 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) 2023, A 5MM/4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING 5F AMPLATZER TORQVUE LP DELIVERY SYSTEM FOR AN 18 MONTH OLD, 3 LB PATIENT. DURING DEVICE PREPARATION, IT WAS REPORTED THAT THE DEVICE WAS PROPERLY PREPARED PER IFU BY ROTATING OCCLUDER COUNTER-CLOCKWISE 1/8 OF ONE TURN TO FACILITATE DEVICE RELEASE UPON DEPLOYMENT. DURING ADVANCEMENT OF THE DEVICE THROUGH THE DELIVERY SHEATH, THE CABLE BECAME DETACHED FROM THE DEVICE. WHEN THE DEVICE WAS ADVANCED OUT OF THE DELIVERY SHEATH, THE EMBOLIZED AND TRAVELED TO THE MAIN PULMONARY ARTERY WITHOUT CAUSING ANY OBSTRUCTION OF BLOOD FLOW. THE DEVICE WAS RETRIEVED VIA TRANSCATHETER SNARE AND THEN IMPLANTED. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SIGNS OR SYMPTOMS DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807030 ↗
• InjuryApr 10, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5X4MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A PATIENT WITH A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. THE DEVICE WAS PLACED EXTRADUCTAL TO THE PATENT DUCTUS ARTERIOSUS (PDA) DEFECT. THE PDA MINIMAL DIAMETER WAS SIZED 3.1MM, THE PDA DIAMETER AT THE AORTIC AMPULLA WAS 8MM, AND THE PDA LENGTH WAS 10MM. IT WAS LATER REPORTED THAT THE DEVICE HAD EMBOLIZED FROM ITS INTENDED LOCATION TWELVE HOURS POST-PROCEDURE. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO EXPLANT THE DEVICE VIA TRANSCATHETER SNARE. IT WAS REPORTED THE INTERVENTION WAS NOT CONSIDERED AN EMERGENCY TO PREVENT IMPAIRMENT OR DEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707792 ↗
• InjuryApr 7, 2023Migration 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) 2023, A 5-4MM AMPLATZER PICCOLOR OCCLUDER WAS IMPLANTED IN A PATIENT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA). THE DIMENSIONS OF THE DEFECT MEASURED 2.7MM FOR PULMONARY ARTERY DIAMETER, 3.5MM AORTIC DIAMETER, AND 9MM FOR DUCTAL LENGTH. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO PEDIATRIC INTENSIVE CARE UNIT (PICU). IT WAS REPORTED THAT A MURMUR WAS DETECTED IN THE PATIENT UPON ARRIVAL AND THE DEVICE WAS FOUND TO HAVE EMBOLIZED INTO THE LEFT LOWER ANTERIOR BASAL PULMONARY ARTERY VIA ECHOCARDIOGRAM. A DECISION WAS MADE TO REINTUBATE THE PATIENT AND AN ATTEMPT WAS MADE TO RETRIEVE THE DEVICE USING A SNARING METHOD BUT WAS UNSUCCESSFUL. THE PATIENT WAS SCHEDULED FOR SURGICAL REMOVAL OF THE DEVICE WHICH OCCURRED ON (B)(6) 2023. IT WAS REPORTED THE PHYSICIAN DID NOT BELIEVE THERE WAS PARTIAL OR COMPLETE BLOCKAGE OF BLOOD FLOW. THE PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704700 ↗
• InjuryDec 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, "SPONTANEOUS CLOSURE OF PATENT DUCTUS ARTERIOSUS IN PRETERM BABIES AFTER FAILED ATTEMPTS AT TRANSCATHETER DEVICE CLOSURE", WAS REVIEWED. THIS RESEARCH ARTICLE REPORTED A CASE STUDY ON A 3 MONTH OLD BORN AT 28 WEEKS GESTATION. BODYWEIGHT AT THE TIME OF CARDIAC CATHETERIZATION WAS 3.5 KG. THE PATIENT HAD RESIDUAL TRACHEOBRONCHOMALACIA AFTER PRIOR REPAIR OF TRACHEOESOPHAGEAL FISTULA, WITH CLINICAL SIGNS OF INCREASED PULMONARY BLOOD FLOW AND VENTILATOR DEPENDENCE. AN ECHOCARDIOGRAM SHOWED MODERATE PATENT DUCTUS ARTERIOSUS (PDA) WITH A CONTINUOUS LEFT-TO-RIGHT SHUNTING. THERE WAS MODERATE LEFT ATRIAL AND LEFT VENTRICULAR ENLARGEMENT ASSOCIATED WITH MILD MITRAL REGURGITATION. ANGIOGRAPHY (WEIGHT 3.5 KG) DEMONSTRATED A TYPE C TUBULAR PDA. THE MINIMUM DIAMETER OF PDA WAS 4.0 MM. THE 5-4 AMPLATZER PICCOLO OCCLUDER WAS PLACED IN AN INTRADUCTAL POSITION IN PDA. OVERNIGHT, THE PATIENT REMAINED SEDATED WITH DEXMEDETOMIDINE. ON CHEST RADIOGRAPH AND ECHOCARDIOGRAM, THE FOLLOWING MORNING, THE DEVICE EMBOLIZATION TO THE LEFT PULMONARY ARTERY (LPA) WAS EVIDENT. REPEAT CATHETERIZATION WAS PERFORMED, AND THE EMBOLIZED DEVICE WAS RETRIEVED. THE PDA APPEARED SMALLER, AND A 6-4 AMPLATZER DUC

  Patient problems: Insufficient Information

  MAUDE report 15899289 ↗
• InjuryNov 11, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 36 WEEK OLD, 2.2 KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER OF 3.8MM, LENGTH OF 13MM, AND DIAMETER AT AORTIC AMPULLA OF 4.2MM. THE SIZING OF THE DEVICE WAS DETERMINED VIA FLUOROSCOPY AND BASED ON THE PHYSICIAN'S DECISION FROM SIZING CHART. THE OCCLUDER WAS IMPLANTED USING AN AMPLATZER TORQVUE LOW PROFILE CATHETER. AT THE MOMENT OF RELEASE FROM THE CABLE, THE DEVICE IMMEDIATELY EMBOLIZED INTO THE LEFT PULMONARY ARTERY (LPA). ON IMAGING REVIEW, IT WAS OBSERVED THAT THERE WAS NO COMPRESSION OF THE DISC ON RELEASE, AND IT HAD THE SAME NATIVE AND UNCOMPRESSED APPEARANCE SIMILAR TO WHAT IS SEEN OUTSIDE OF THE BODY WHILE ON THE CABLE DURING PREPARATION. ONCE EMBOLIZED, THE DEVICE WAS ANGLED ACROSS THE ARTERY AND DID NOT STOP THE FLOW OF BLOOD. THE PHYSICIAN SNARED THE DEVICE AND REMOVED IT FROM THE LPA, BUT THEN THE DEVICE FELL OFF THE SNARE INTO THE INFERIOR VENA CAVA. THE DEVICE WAS CAPTURED AGAIN WITH A NON-ABBOTT SNARE AND REMOVED FROM THE PATIENT. THE PHYSICIAN REPORTED THAT THE DEVICE CHOSEN WAS TOO SMALL FOR THE PDA, AND IN HINDSIGHT

  Patient problems: Obstruction/Occlusion

  MAUDE report 15785248 ↗
• InjuryJun 14, 2022Malposition of Device; Malposition of Device

  AN ARTICLE FROM THE MEDICAL CONFERENCE ABSTRACT MAGAZINE FOR (B)(6) SOCIETY OF CONGENITAL INTERVENTIONAL CARDIOLOGY, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY 9 DAYS IN AGE MALE, 3200G, KRICHENKO TYPE A, DIAMETER OF PULMONARY ATRESIA (PA) SIDE FOR PATENT DUCTUS ARTERIOSUS (PDA ) 2.9MM, AORTIC ROOT ( AO) SIDE FOR PDA 4.3MM, LENGTH OF PDA 5.5MM. AN AMPLATZER PICCOLO OCCLUDER 5 MM X 4 MM WAS IMPLANTED ON AN UNKNOWN DATE AND YEAR, THE DEVICE PROTRUDED IN LEFT PULMONARY ARTERY (LPA) NO SIGNIFICANT STENOSIS WAS OBSERVED. NOVEL MODERATE TRICUSPID REGURGITATION WAS ALSO CONFIRMED WHICH MIGHT HAVE CAUSED BY CHORDAL RUPTURE OF TRICUSPID. AT THE TIME OF ONE YEAR AFTER THE SURGERY, TRICUSPID REGURGITATION HAS BECOME MILD. NO VESSEL STENOSIS HAS OBSERVED AND NO ADDITIONAL INFORMATION WAS AVAILABLE. [THE AUTHOR OF THE ARTICLE IS YOSHIYUKI KAGIYAMA, MD, (B)(6).

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 14689643 ↗

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-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-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-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