Amplatzer Piccolo™ 9-PDAP-05-02-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 05415067031037), received between Dec 20, 2019 and Jan 30, 2026 — classified as 4 deaths, 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (28 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Premature Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223993 ↗
• InjuryDec 8, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATIENT'S GESTATIONAL AGE WAS 22.5 WEEKS. THE PDA MINIMAL DIAMETER WAS 3.6MM, THE PDA DIAMETER AT AORTIC AMPULLA WAS 4MM AND PDA LENGTH WAS 10MM. DURING PROCEDURE, THE TEAM BELIEVED THE AORTIC (AO) DISC MAY BE PROTRUDING INTO THE AO SLIGHTLY SO THE DEVICE WAS REMOVED WITHOUT BEING RELEASED FROM CABLE. A NEW 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN, PLACED WITH NO ISSUE AND RELEASED. IMMEDIATELY AFTER RELEASE, THE DEVICE WAS NOTED TO MIGRATE TOWARDS THE PULMONARY ARTERY (PA) WITH THE PA DISC AND THE CENTER LOBE PROTRUDING INTO THE PA. ALTHOUGH THERE WAS STILL FLOW INTO THE LEFT PULMONARY ARTERY (LPA), IT WAS DETERMINED THE DEVICE WAS UNSTABLE AND BLOCKING TOO MUCH FLOW SO THE DEVICE WAS RETRIEVED VIA PERCUTANEOUS RETRIEVAL AND REMOVED WITHOUT INCIDENCE. THE FIRST 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS PLACED AGAIN AND RELEASED WITHOUT INCIDENCE OR OBSTRUCTION OF THE AO OR PA. THE IMPLANTER BELIEVE WAS THE CAUSE OF EMBOLIZATION WAS INCORRECT SIZING. THE PATIENT REMAINED STABL

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 23745802 ↗
• InjuryDec 5, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5MM X 2MM AMPLATZER PICCOLO WAS CHOSEN FOR IMPLANTED USING A 4F TVLP CATHETER. THE SIZING OF THE DEVICE WAS DETERMINED BASED ON IFU SIZING CHART GUIDANCE AND PHYSICIAN DECISION. THE PATIENT HAD A PATENT DUCTUS ARTERIOSUS (PDA) WITH DIMENSIONS OF AO AMPULLA 4.8 MM, LENGTH 6.6 MM, AND PA END 3.2 MM. IMAGING MODALITIES USED DURING THE PROCEDURE INCLUDED ANGIOGRAPHY AND TRANSTHORACIC ECHOCARDIOGRAM (TTE). A STABILITY CHECK WAS PERFORMED, AND NO DIFFICULTY WITH IMPLANTATION SUCH AS MULTIPLE RECAPTURES OR REPOSITIONING WAS NOTED. INITIALLY, A 4-2MM AMPLATZER PICCOLO DEVICE WAS ATTEMPTED, BUT TTE REVEALED A RESIDUAL SHUNT; THIS DEVICE WAS REMOVED AND IT WAS NEVER RELEASED AND WAS UPSIZED, AND A 5-2 MM AMPLATZER PICCOLO DEVICE WAS PLACED WITH NO LEAK DETECTED. ON (B)(6) 2025, MIGRATION OF THE DEVICE WAS IDENTIFIED, WITH THE POSTERIOR DISK PROTRUDING INTO THE DESCENDING AORTA, CAUSING OBSTRUCTION NOTED ON ECHOCARDIOGRAPHY. MIGRATION WAS FIRST SUSPECTED ON CHEST X-RAY AND CONFIRMED BY TTE. THE DEVICE HAD SHIFTED WITHIN THE INTENDED IMPLANT SITE RATHER THAN COMPLETELY DISLODGING. THE IMPLANTER BELIEVES MIGRATION OCCURRED AFTER HEMODYNAMIC INSTABILITY IN

  Patient problems: Obstruction/Occlusion

  MAUDE report 23729951 ↗
• InjuryOct 15, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PERCUTANEOUS CLOSURE OF THE PATENT DUCTUS ARTERIOSUS (PDA) USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATIENT WAS 37 WEEKS OLD DURING THE PROCEDURE AND NOW 3 MONTHS AND 3 DAYS OLD, WEIGHTING 2000 GRAM. THE DUCTAL ANATOMY MEASURED 3.3MM AT THE NARROWEST SECTION, 4.8MM AT THE AORTIC AMPULLA AND HAD A TOTAL LENGTH OF 10MM. SINCE THE PATIENT WAS RIGHT AT 2000GRAMS, AND WAS STRADDLING THE INSTRUCTIONS FOR USE (IFU) SIZING OPTIONS, THE PHYSICIAN DECIDED TO SIZE ACCORDING TO THE <2KG, INTRADUCTAL PLACEMENT AND SELECTED THE 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER. BOTH FLUOROSCOPY (FLURO) AND ECHOCARDIOGRAM (ECHO) IMAGING SHOWED GOOD PLACEMENT WITH NO RESIDUAL FLOW AROUND THE DEVICE, AND THE DEVICE WAS THEN RELEASED. THE X-RAY TAKEN THE MORNING ON (B)(6) 2025 SHOWED THE DEVICE HAD SHIFTED POSITIONS. THE CORRESPONDING TRANSTHORACIC ECHOCARDIOGRAM (TTE) ECHO IMAGES SHOWED THE DEVICE HAD MIGRATED TO THE LEFT PULMONARY ARTERY (LPA) AND THERE WAS A SMALL RESIDUAL FLOW THROUGH THE OPEN PDA. THE PATIENT WAS BROUGHT BACK INTO THE PEDIATRIC CARDIAC CATHETERIZATION LAB (CATH LAB) WHERE THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285507 ↗
• InjuryJul 8, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED. THE DUCTAL MEASUREMENTS WERE: AMPULLA 3.6MM, LENGTH 9.2MM, AND PA MEASUREMENT 3.2MM. APPROXIMATELY 3 HOURS LATER, THE DEVICE WAS FOUND TO HAVE EMBOLIZED INTO THE MAIN PA. THE DEVICE WAS RETRIEVED PERCUTANEOUSLY AND THE DUCT WAS CLOSED WITH A 6MM NON-ABBOTT DEVICE TO RESOLVE THE EVENT. THE PATIENT WAS TRANSFERRED TO THE PICU IN STABLE CONDITION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PHYSICIAN BELIEVES THE DEVICE WAS POTENTIALLY MIS-SIZED AS THE CAUSE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437162 ↗
• InjuryJun 16, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A AMPLATZER PICCOLO OCCLUDER 5 MM X 4 MM WAS CHOSEN FOR IMPLANTATION UTILIZING A 4F TORQVUE LP DELIVERY SYSTEM. DIMENSIONS WERE AS FOLLOWS: PDA MINIMAL DIAMETER (MM): 4.5MM, PDA DIAMETER AT AORTIC AMPULLA (MM): 4.5MM, PDA LENGTH (MM): 13MM. THE DEVICE WAS LOADED AND DEPLOYED INTRADUCTAL. INITIAL POSITION HAD SOME ARCH OBSTRUCTION SO THE DEVICE WAS BROUGHT MORE PROXIMAL BUT RESULTED IN LEFT PULMONARY ARTERY STENOSIS. THE DECISION WAS MADE TO USE A 5-2MM AMPLATZER PICCOLO DEVICE. DEVICE WAS ATTEMPTED TO BE PLACED INTRADUCTAL WITH VENOUS ACCESS. PULSE CHECKLIST WAS USED. NO RECAPTURES WERE PERFORMED. WHEN THE DISTAL DISC WAS DEPLOYED, THE OCCLUDER DETACHED FROM THE DELIVERY CABLE. ATTEMPTS WERE MADE TO SNARE THE PROXIMAL PIN THROUGH THE DELIVERY CATHETER WITH A MICRO CATHETER AND MICRO SNARE (4MM) BUT WAS UNSUCCESSFUL. FINALLY, THE ENTIRE DEVICE AND CATHETER WAS PULLED INTO THE DUCTUS AND RELEASED USING THE CABLE AS A "PUSHER." DESPITE THIS, THE OCCLUDER WAS ABLE TO BE PLACED IN THE DESIRED LOCATION. THERE WERE NO PATIENT CONSEQUENCES AND WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214832 ↗
• InjuryJan 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 10.3 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

  Patient problems: Sepsis

  MAUDE report 21219634 ↗
• InjurySep 19, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257252 ↗
• DeathSep 13, 2024Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 43 DAY OLD, 1.12 KG PATIENT WITH A PATENT DUCTUS ARTERIOSUS. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS. AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE NEONATAL INTENSIVE CARE UNIT (NICU). ON (B)(6) 2024, THERE WAS CONCERN THAT THE DEVICE HAD MIGRATED DUE TO LOW DIASTOLIC BLOOD PRESSURE, HYPOTENSION, AND LOUD MURMUR. ON ECHOCARDIOGRAPHY, A SMALL LEFT-TO-RIGHT RESIDUAL SHUNT WAS VISUALIZED. MILD AORTIC STENOSIS WAS NOTED. ON (B)(6) 2024, A BEDSIDE PARACENTESIS WAS PERFORMED TO COLLECT FLUID FOR STUDIES. IT WAS NOTED THAT THE PATIENT HAD DISSEMINATED INTRAVASCULAR COAGULATION AND RECEIVED MULTIPLE LATELET INFUSIONS. EXPLORATORY LAPAROTOMY SHOWED A MASSIVE AMOUNT OF INTRAABDOMINAL BLOOD THAT WAS EVACUATED. THE PATIENT HAD A PROGRESSIVE DETERIORATION FOLLOWING THE PARACENTESIS, INCLUDING HAVING HYPOTENSION AND ACIDEMIA. THE PATIENT PASSED AWAY. THE PRIMARY CAUSE OF DEATH WAS DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THE SECONDARY CAUSES OF DEATH WERE UNRELENTING INTRA-ABDOMINAL BLEEDING, SEVERE CHOLESTASIS PRESUMED SECONDARY TO PROLONGED TOTAL PARENTERAL NUT

  Patient problems: Aortic Valve Stenosis; Low Blood Pressure/ Hypotension

  MAUDE report 20215935 ↗
• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 4-WEEK-OLD, 1.1KG PATIENT WITH A PATENT DUCTUS ARTERIOSUS. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS. AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE NEONATAL INTENSIVE CARE UNIT (NICU). THAT EVENING, THE PATIENT REQUIRED INCREASE IN RESPIRATORY SUPPORT. ON THE MORNING OF (B)(6) 2024, THE PATIENT WAS IN RESPIRATORY ACIDOSIS WITH CARBON DIOXIDE UP TO A MAXIMUM OF 119 WITH COMPLETE OPACIFICATION OF THE LEFT LUNG AND RIGHT UPPER LOBE. VENTILATION SETTINGS WERE INCREASED, AND VENTILATION IMPROVED. AROUND NOON, THE PATIENT SHOWED SIGNS OF HYPOTENSION, AND THE PATIENT DEVELOPED PERSISTENT HYPOTENSION AND HYPOXIA THROUGHOUT THE DAY. THERE WAS CONCERN FOR SEPSIS WITH LEUKOPENIA, SO BLOOD CULTURE WAS OBTAINED AND ANTIBIOTICS WERE PRESCRIBED. PATIENT WAS SUSPECTED TO BE IN SEPTIC SHOCK. MEDICATIONS WERE STARTED WITH INTERMITTENT IMPROVEMENT TO BLOOD PRESSURE. A BLOOD TRANSFUSION WAS ORDERED TO SUPPORT OXYGEN CARRYING CAPACITY. THE PATIENT HAD RECEIVED STRESS DOSES OF HYDROCORTISONE PRIOR TO CATH AND THE FOLLOWING DAY. PERSISTENT HYPOXIA WAS PRESENT AND NOT RESPONSIVE

  Patient problems: Hypoxia; Low Blood Pressure/ Hypotension; Respiratory Insufficiency; Sepsis; Unspecified Infection

  MAUDE report 20213749 ↗
• MalfunctionSep 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F COOK MULIN SHEATH. DURING DEPLOYMENT, 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 REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE GOT 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 20212417 ↗
• DeathMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AN AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A 950G PRETERM BABY. THE DEVICE WAS SUCCESSFULLY IMPLANTED. FEW HOURS POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A SEPTIC SHOCK AND PASSES AWAY ON THE SAME DAY.

  Patient problems: Sepsis

  MAUDE report 18963333 ↗
• DeathDec 21, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA) USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER IN A PREMATURE INFANT BORN AT 23 WEEKS GESTATION WITH A HEMODYNAMICALLY SIGNIFICANT PDA. THE WEIGHT OF THE INFANT AT IMPLANT WAS 1.1KG. TPRE-PROCEDURE ECHOCARDIOGRAPHY SHOWED A MINIMAL DUCTUS ARTERIOSUS DIAMETER OF 3.3 MM. REPEAT INTRA-OPERATIVE ECHOCARDIOGRAPHY SHOWED A MINIMAL DUCTUS DIAMETER OF 3.0 MM. INTRA-OPERATIVE ANGIOGRAM SHOWED A DUCTUS ARTERIOSUS LENGTH OF 10.2 MM. THE MINIMAL DUCTUS DIAMETER WAS 1.7 MM AND THE AORTIC AMPULLA HAD A DIAMETER OF 3.8 MM. THE 04-02 OCCLUDER WAS DEPLOYED INTO THE DUCTUS ARTERIOSUS WITHOUT DIFFICULTY, BUT DUE TO A PERSISTENT RESIDUAL SHUNT AROUND THE DEVICE SEEN ON ECHOCARDIOGRAPHY A DECISION WAS MADE TO NOT RELEASE THE DEVICE FROM THE DELIVERY CABLE AND THE DEVICE WAS REMOVED. A SECOND ATTEMPT WAS MADE USING A 05-02 PICCOLO OCCLUDER. THE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY INTRA-DUCTAL AND RELEASED AFTER CONFIRMING GOOD POSITIONING WITHOUT PULMONARY ARTERY OR AORTIC OBSTRUCTION. THE POSITION OF THE PICCOLO OCCLUDER WAS BETWEEN THE TEMPERATURE PROBE AND A SUPERIO

  Patient problems: Hypoxia; Obstruction/Occlusion

  MAUDE report 18375619 ↗
• InjuryDec 6, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 2 MONTH OLD PATIENT WEIGHING 2.2 KG WITH DOWN SYNDROME, HIGH ANORECTAL MALFORMATION (ARM), NEAR SYSTEMIC PULMONARY ARTERY PRESSURES AND LARGE PERICARDIAL EFFUSION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5-2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 4 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND INITIAL ATTEMPTS TO RETRIEVE THE DEVICE HAD FAILED AS THE EMBOLIZED DEVICE WAS DEEPLY LODGED INTO THE SMALLER RIGHT LOWER LOBE BRANCH. A DECISION WAS MADE TO IMPLANT AN 8MM AMPLATZER VASCULAR PLUG II INTO THE PDA. AFTER SUCCESSFUL IMPLANT, IT WAS REPORTED THE PERICARDIAL EFFUSION WAS DRAINED AND THE PATIENT WAS CONSERVATIVELY OBSERVED FOR PICCOLO EMBOLIZATION. IT WAS REPORTED THE PICCOLO WAS RECOVERED UNEVENTFULLY ON AN UNKNOWN DATE. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278650 ↗
• InjuryAug 24, 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 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 30-WEEK OLD, 950G PATIENT WITH A PATENT DUCTUS ARTERIOSUS (PDA), USING 04F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PHYSICIAN MEASURED THE DUCTUS AS LENGTH 14.99 MM, AORTIC AMPULLA 5.33 MM, MID DUCT TIGHTEST SPOT 4.09 MM, THE LEFT PULMONARY ARTERY (LPA) OPENING WAS 3.44 MM. DURING PLACEMENT ATTEMPTS OF THE DEVICE, IT WAS NOTED TO BE SITTING A BIT PROXIMAL. IT WAS AGREED THAT THE DEVICE IS OK TO BE RELEASED. DURING THE RELEASE, THE DEVICE STRETCHED A BIT ANTERIORLY AND THEN IMMEDIATELY AFTER RELEASE COMPACTED AND SHIFTED ANTERIORLY. IN THE IMPLANTER¿S OPINION, THE CAUSE OF MIGRATION WAS DUE TO DEVICE SIZE AND MOVEMENT ON RELEASE. AS THE POSITION OF THE DEVICE WAS UNSATISFACTORY, IT WAS DECIDED TO REMOVE THE DEVICE VIA SNARE. THE SNARING PROCESS WENT WELL INITIALLY; HOWEVER, THERE WAS AN ERROR WITH THE SNARE, WHERE THE PRESSURE WAS RELEASED FROM THE SNARE AND THE DEVICE FELL OFF THE SNARE INTO THE INFERIOR VENA CAVA (IVC). THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A REPLACEMENT 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612362 ↗
• MalfunctionAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) AS PMS JAPAN. IT WAS REPORTED THAT ON (B)(6) 2023, A 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT FOR A PATENT DUCTUS ARTERIOSUS (PDA). THE MINIMAL DUCTAL DIAMETER WAS 2.4MM, ON ECHOCARDIOGRAPHY AND 3.1MM ON ANGIOGRAPHY. THE MAXIMUM DUCTAL DIAMETER WAS 4.3MM, ON ECHOCARDIOGRAPHY AND 5.2MM ON ANGIOGRAPHY. THE DUCTAL LENGTH OF THE PDA WAS 5MM ON ECHOCARDIOGRAPHY AND 3.5MM ON ANGIOGRAPHY. THE PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, IT WAS NOTED THAT THE FLOW VELOCITY OF THE LEFT PULMONARY ARTERY WAS ACCELERATED UP TO 2.2 M/SEC, WHICH WAS CLINICALLY SIGNIFICANT STENOSIS OF THE LEFT PULMONARY ARTERY. THIS STENOSIS WAS CAUSED BY A PARTIAL OBSTRUCTION FROM THE PICCOLO OCCLUDER. IT WAS NOT BELIEVED THAT THE PICCOLO OCCLUDER MIGRATED. THE PATIENT HAS BEEN CONTINUOUSLY MONITORED AND HAS NOT HAD ANY SYMPTOMS. NO TREATMENT OR INTERVENTION WAS PERFORMED OR PLANNED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17541788 ↗
• MalfunctionApr 18, 2023Migration or Expulsion of Device; Patient-Device Incompatibility; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED INTO A PATENT DUCTUS ARTERIOSUS (PDA). THE DISTAL DISC WAS NOTED TO BE CLOSE TO THE AORTA. THERE WAS NO DEFINED COARCTATION OF THE AORTA OBSERVED AT THE TIME OF IMPLANT. AFTER A 3 MONTH FOLLOW-UP ON (B)(6) 2023, IT WAS OBSERVED THAT THERE MAY BE AN AORTIC COARCTATION NEAR THE SITE OF THE IMPLANTED DEVICE THAT LOOKS TO BE AT THE SAME HEIGHT OR LEVEL AS THE PDA. THE AORTA IMMEDIATELY POSTERIOR TO THE PDA HAS NOT GROWN OR WIDENED SINCE THE IMPLANT PROCEDURE AS WOULD BE EXPECTED. CATHETER FILMS FROM THE ORIGINAL IMPLANT WERE EVALUATED, AND IT WAS REPORTED THAT AN AORTIC COARCTATION MAY HAVE ALREADY BEEN PRESENT AT THE TIME OF IMPLANT, BUT THERE WAS NO PRONOUNCED TIGHTENING NOTED AT THE TIME OF IMPLANT SO THIS COULD NOT BE CONFIRMED AND WAS ONLY SPECULATION. THE ECHOCARDIOGRAM STUDY SHOWED AORTIC FLOW WAS INTERRUPTED ON THE PDA SIDE WITH THE PICCOLO DEVICE AS WELL AS THE POSTERIOR WALL OF THE AORTA. THE PHYSICIAN BELIEVED THAT THE DEVICE MAY HAVE MIGRATED POSTERIORLY TOWARDS THE AORTA/AORTIC AMPULLA DUE TO PDA CONSTRICTION, WHICH MAY BE WHAT WAS CAUSING THE TURBULENT FLOW NEAR THE PICCOLO SIDE AND

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16765590 ↗
• InjuryApr 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 2.9 KG PATIENT. DURING PROCEDURE, THE DEVICE WAS IMPLANTED. THE DEVICE EMBOLIZED LESS THAN ONE MINUTE AFTER THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE. THE SIZING OF THE DEVICE WAS DETERMINED BY PULMONARY ARTERIAL ANGIOGRAM AND TRANS-THORACIC ECHOCARDIOGRAM. THE DEVICE WAS COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE IMPLANTER BELIEVES THAT THE DEVICE WAS NOT RIGID ENOUGH TO MAINTAIN POSITION. THE DEVICE WAS SNARED, RETRIEVED AND REMOVED FROM THE PATIENT AND A 5-4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, AND NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727302 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATENT DUCTUS ARTERIOSUS (PDA) MINIMAL DIAMETER WAS MEASURED TO BE 3.42MM. THE PDA DIAMETER AT THE AORTIC AMPULLA WAS MEASURED TO BE 3.50MM. THE PDA LENGTH WAS MEASURED AT 8.55MM. IT WAS REPORTED THAT THE DELIVERY CATHETER WAS TOO STIFF AND SIGNIFICANTLY MANIPULATED THE DUCT ANATOMY WHILE ATTEMPTING THE PLACE THE DEVICE. A 4F NON-ABBOTT DELIVERY SYSTEM WAS USED TO ACCESS THE PDA VIA THE RIGHT FEMORAL VEIN APPROACH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. 24 HOURS POST PROCEDURE, IT WAS OBSERVED THAT THE PATIENT EXPERIENCED MODERATE TRICUSPID VALVE REGURGITATION VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). ON (B)(6) 2023, THERE WAS NO NOTICEABLE TRICUSPID VALVE REGURGITATION SEEN ON THE TEE. THE PATIENT WAS REPORTED AS STABLE AND RECOVERED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 16529632 ↗
• InjuryMar 10, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED. 4 WEEKS LATER, IT WAS REPORTED THAT THE DEVICE EMBOLIZED. THE PATIENT WAS REFERRED FOR SURGICAL RETRIEVAL OF THE DEVICE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT THE DEVICE WAS PLACED INTRADUCTALLY. THE FOLLOWING DAY AFTER THE PROCEDURE WAS PERFORMED, IT WAS OBSERVED THAT THE DEVICE WAS STILL IN THE ORIGINAL IMPLANT POSITION. ABOUT THREE WEEKS AFTER THE DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED APNEA AND BRADYCARDIA. AN ECHOCARDIOGRAM WAS PERFORMED, AND IT WAS OBSERVED THAT THE DEVICE HAD PARTIALLY MIGRATED INTO THE AORTA. AFTER THE DEVICE MIGRATED, IT WAS CAUSING A PARTIAL OBSTRUCTION OF BLOOD FLOW. THE DEVICE WAS SURGICALLY REMOVED ON (B)(6) 2023. THE PATIENT WAS REPORTED AS STABLE AND DISCHARGED.

  Patient problems: Bradycardia; Dyspnea; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 16526002 ↗
• InjuryFeb 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE FIRST DEVICE EMBOLIZED IMMEDIATELY AFTER RELEASE FROM THE DELIVERY CABLE. THE EMBOLIZED DEVICE WAS EXPLANTED AND THE 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED ALSO ON (B)(6) 2023. THE PATIENT BECAME HYPOTENSIVE AFTER THE SECOND DEVICE EMBOLIZED AND ADRENALINE WAS ADMINISTERED TO TREAT THE HYPOTENSION. THE SURGICAL DRAINAGE WAS DONE EMERGENTLY TO PREVENT PERMANENT IMPAIRMENT OR DEATH. THE SECOND EMBOLIZED DEVICE REMAINED IMPLANTED. THE PATIENT WAS EXTUBATED AND WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448481 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT. PRIOR TO THE PROCEDURE AN X-RAY WAS PERFORMED AND RIGHT LUNG HAZINESS WITH POSSIBLE ABDOMINAL PNEUMATOSIS WAS NOTED. THE PDA MINIMAL DIAMETER WAS SIZED TO BE 3.5MM. THE DIAMETER AT AORTIC AMPULLA WAS MEASURED TO BE 5.0MM. THE DEVICE WAS PLACED INTRADUCTALLY AND RELEASED. THE FOLLOWING MORNING THE ECHOCARDIOGRAM AND CHEST X-RAY CONFIRMED PLACEMENT WAS SATISFACTORY AND THAT THERE WAS NO FLOW THROUGH THE DUCT. ALSO, RIGHT AND LEFT VENTRICULAR APPEARED NORMAL AND THERE WAS NO SIGN OF PULMONARY HYPOTENSION. LATER THAT EVENING, THERE WAS BLOOD SEEN IN NASOGASTRIC TUBE (NGT) OR OROGASTRIC TUBE (OGT) AND A PULMONARY HEMORRHAGE WAS SUSPECTED. THE PATIENT WENT INTO ARREST AND PASSED AWAY ON (B)(6) 2022. THERE WAS NO DEFECT OR THROMBUS OBSERVED ON THE DEVICE DURING THE PATIENT AUTOPSY. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT THE PATIENT HAD A PULMONARY HEMORRHAGE IN THE RIGHT LOWER LOBE OF THE LUNG, WITH EVIDENCE OF DIFFUSE BRONCHOPNEUMONIA WITH HEAVY GROWTH OF STAPHYLOCOCCUS AUREUS (MRSA). POST PATIENT DEAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044698 ↗
• InjuryDec 2, 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 4 WEEK OLD PATIENT AT 30 WEEKS GESTATION. WEIGHT AT THE TIME OF CARDIAC CATHETERIZATION WAS 1.86 KG. THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL FOR TRANSCATHETER DEVICE CLOSURE OF THE PATENT DUCTUS ARTERIOSUS (PDA) AFTER FAILURE OF IBUPROFEN THERAPY. ECHOCARDIOGRAPHY DEMONSTRATED A LARGE PDA (DIAMETER 3 MM) WITH A LEFT-TO-RIGHT SHUNTING, MODERATE LEFT HEART ENLARGEMENT, AND MILD MITRAL REGURGITATION. AN ANGIOGRAM DEMONSTRATED A TYPE C TUBULAR PDA WITH A MINIMUM DIAMETER OF 3.5 MM. FIRST, AN 5-4 AMPLATZER PICCOLO OCCLUDER DEVICE (5¿4 SIZE) WAS DEPLOYED. AS THE DEVICE WAS TOO LONG AND ENCROACHED ON THE AORTA AND LPA, THE DEVICE WAS REMOVED BEFORE RELEASE. A SECOND AMPLATZER PICCOLO OCCLUDER (5-2) DEVICE WAS ATTEMPTED. ON RELEASE, THE DEVICE EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A 10-MM GOOSE-NECK SNARE. THE NEXT MORNING, AN ECHOCARDIOGRAM SHOWED THAT THE PDA WAS SIGNIFICANTLY SMALLER. ON REPEAT ECHOCARDIOGRAM 3 DAYS LATER, PDA HAD C

  Patient problems: Insufficient Information

  MAUDE report 15902336 ↗
• InjuryDec 2, 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 5 WEEK OLD PATIENT BORN AT 28 WEEKS¿ GESTATION. BODYWEIGHT AT THE TIME OF CARDIAC CATHETERIZATION WAS 1.26 KG. MULTIPLE DYSMORPHIC FEATURES LED TO THE DIAGNOSIS OF CORNELIA DE LANGE SYNDROME. ECHOCARDIOGRAPHY DEMONSTRATED A HEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS (PDA), PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECT PARTIALLY COVERED BY PSEUDOANEURYSMAL TISSUE, AND MILD VALVAR PULMONARY STENOSIS (PEAK GRADIENT 25 MMHG). DUE TO THE PRESENCE OF PULMONARY CONGESTION AND THE INABILITY TO WEAN VENTILATORY SUPPORT, THE DECISION WAS MADE TO CLOSE THE PDA USING A TRANSCATHETER DEVICE. ANGIOGRAPHY SHOWED A TYPE F-HOCKEY-STICK-SHAPED PDA WITH A MINIMUM DIAMETER OF 4 MM. A 5-2 AMPLATZER PICCOLO OCCLUDER DEVICE WAS DEPLOYED. AFTER ECHOCARDIOGRAPHIC CONFIRMATION, THE DEVICE WAS RELEASED. ON RELEASE, THE DEVICE EMBOLIZED INTO THE MAIN PULMONARY ARTERY (MPA). ATTEMPTS TO RETRIEVE THE DEVICE USING A GOOSE-NECK SNARE WERE COMPLICATED BY A MODERATE PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS

  Patient problems: Insufficient Information

  MAUDE report 15901414 ↗
• InjurySep 29, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, "AORTIC MIGRATION OF AMPLATZER PICCOLO DUCTAL OCCLUDER", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY ON A 4 MONTH OLD FORMER 23 WEEK PREMATURE BABY, 610GRAMS UNDERWENT DEVICE CLOSURE OF A LARGE PATENT DUCTUS ARTERIOSUS IN THE CARDIAC CATHETERIZATION LAB WITH AN AMPLATZER PICCOLO DEVICE AT 2.4KG. HE PATENT DUCTUS ARTERIOSUS MEASURED 2.5 MM AT ITS NARROWEST DIMENSION AND 8.1 MM LONG AND WAS CLOSED USING A 5-2 AMPLATZER PICCOLO OCCLUDER, BASED ON THE PROCTOR¿S RECOMMENDATION. ANGIOGRAPHY DURING THE PROCEDURE SHOWED A DEVICE WHICH SITS LARGELY INTRADUCTUALLY. INTRA-PROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED NO EVIDENCE OF OBSTRUCTION AND HENCE THE DEVICE WAS DEPLOYED IN THIS POSITION. FOLLOWING THE RELEASE OF DEVICE PART OF THE AORTIC DISC PROTRUDED INTO THE AORTA WHILE MOST OF THE DEVICE IS STILL IN THE DUCTUS. NO ATTEMPT WAS MADE AT RETRIEVING OR REPOSITIONING THE DEVICE AT THIS POINT SINCE ON ECHOCARDIOGRAM THERE APPEARED TO BE NO OBSTRUCTION. POST PROCEDURE ECHOCARDIOGRAM ALSO SHOWED NO EVIDENCE OF PULMONARY OR AORTIC OBSTRUCTION 6 HOURS, 24 HOURS, AND 1-WEEK POST-PROCEDURE. A FOLLOW-UP ECHOCARDIOGRAM PERFORMED 4 WEEKS POST-PROCEDURE SHOWED INTERVAL

  Patient problems: Obstruction/Occlusion

  MAUDE report 15505908 ↗

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