Amplatzer Piccolo™ 9-PDAP-04-02-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05415067031006), received between Nov 8, 2019 and Nov 21, 2025 — classified as 7 deaths, 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (16 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 31 reports, in the reporter's own words as published by the FDA.

• DeathNov 21, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  HOLD LSG 11/21/2025.IT WAS REPORTED THAT ON (B)(6) 2025, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING AN UNKNOWN SIZE AMPLATZER TORQVUE LP DELIVERY SYSTEM (TVLP). THE PATIENT WAS BORN AT ( B4 WEEKS AND 11 WEEKS YOUNG AT THE TIME OF PROCEDURE. THE PDA MINIMAL DIAMETER WAS 2.9MM ON PULMONARY ARTERY (PA) AMPULLA AND 3.4MM AT THE AORTIC AMPULLA. THE PDA LENGTH WAS 7MM. THE PICCOLO PULSE CHECKLIST WAS NOT USED. THE SIZING OF THE DEVICE WAS DETERMINED BY ANGIOGRAPHIC MEASUREMENTS. THE DEVICE WAS SUCCESSFULLY IMPLANTED IN ONE ATTEMPT INTRADUCTALLY IN THE PDA. THERE WAS PLENTY OF SPACE BETWEEN THE PA DISC, AND THE END OF THE LEFT PULMONARY ARTERY (LPA), AND EVEN MORE SPACE BETWEEN THE AORTIC (AO) DISC AND THE AO IN THE AO AMPULLA. THERE WAS GOOD COMPRESSION ON THE PA DISC AND THE WAIST OF THE PICCOLO, NOT MUCH ON THE AO DISC, BUT THAT WAS VERY NORMAL SINCE MOST AO AMPULLAS FLARE OPEN QUITE A BIT BOTH DISCS AND THE WAIST WE ALL VERY STABLE. THE PHYSICIAN WERE PREPPING FOR A CONFIRMATIVE ANGIOGRAM WHILE CONFIRMING PLACEMENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PICCOLO QUICKLY EMBOLIZED TO THE PA THEN LPA. THE DEC

  Patient problems: Coronary obstruction/occlusion; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Perforation

  MAUDE report 23619645 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE WAS NOT TAKING PROPER SHAPE. 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 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 22689477 ↗
• InjuryJul 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541233 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2025, IT'S NOTED THAT THE PATIENT HAD POSITIVE BLOOD CULTURES SHOWING YEAST.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Sepsis; Tachycardia; Unspecified Infection

  MAUDE report 22373157 ↗
• MalfunctionApr 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21833584 ↗
• DeathFeb 4, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 4F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS A PREMATURE INFANT (DOB (B)(6) 2024) WITH A HEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS (PDA). PATIENT WAS REFERRED FOR TRANSCATHETER CLOSURE FOLLOWING THREE (3) PRIOR FAILED ATTEMPTS TO CLOSE THE PDA WITH MEDICAL THERAPY. THE PATIENT WEIGHED 1050 GRAMS AT 4 WEEKS OF LIFE. AN ANGIOGRAM DEMONSTRATED A PDA WITH A MINIMAL DIAMETER OF 2.5 MM, AORTIC END DIAMETER OF 3.3 MM AND A LENGTH OF 11.9 MM. THE 04MM X 02MM AMPALTZER PICCOLO OCCLUDER WAS DEPLOYED INTRA-DUCTAL VIA RIGHT FEMORAL VENOUS ACCESS WITHOUT DIFFICULTY. IMPLANTING TEAM UTILIZED THE PICCOLO PULSE CHECKLIST. HOWEVER, FOLLOWING DEVICE RELEASE THERE WAS EVIDENCE OF PROTRUSION INTO THE LEFT PULMONARY ARTERY (LPA) CAUSING PARTIAL OBSTRUCTION AND A DECISION WAS MADE TO ATTEMPT RETRIEVAL OF THE DEVICE WITH A 5 MM GOOSENECK SNARE AND SUBSEQUENT REPOSITIONING. HOWEVER, DURING THE ATTEMPT TO RETRIEVE THE DEVICE THE DEVICE WAS INADVERTENT DISLODGED INTO THE MAIN PULMONARY ARTERY AND ADDITIONAL ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE WITH A 5 MM GOOSENECK S

  Patient problems: Bradycardia; Embolism/Embolus; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 21309418 ↗
• InjuryJan 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 TO TREAT A PATIENT WITH A WEIGHT OF 0.95KG, A MINIMAL DUCTUS PERIMETER 3.2MM AND A DUCTAL LENGTH OF 9MM USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATENT DUCTUS ARTERIOSUS (PDA) WAS MEASURED WITH FLUOROSCOPY AND TRANSTHORACIC ECHOCARDIOGRAM (TTE). DURING THE PROCEDURE THE OCCLUDER WAS DEPLOYED AND RE-CAPTURED ONCE TO POSITION THE OCCLUDER MORE INTRADUCTAL TOWARDS THE PULMONARY ARTERY SIDE. AFTER THE SECOND DEPLOYMENT THE OCCLUDER WAS EVALUATED THROUGH TTE AND FLUOROSCOPY. THE OCCLUDER MET ALL CRITERIA AND WAS RELEASED FROM THE DELIVERY CABLE. AFTER 10 MINUTES THE OCCLUDER REMAINED INTACT AND STABLE. ONE MONTH POST-PROCEDURE IT WAS NOTED THAT THE OCCLUDER MIGRATED TOWARDS THE AORTIC AMPULLA WITH APPROXIMATELY 1 DISC PROTRUDING ONTO THE AORTA AND CAUSING A COARCTATION. PER THE PHYSICIAN, THE FASTER CLOSURE OF THE PULMONARY ARTERY SIDE MAY HAVE PUT PRESSURE ON THE OCCLUDER AND CAUSED IT TO SHIFT. THE PATIENT STATUS WAS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21191664 ↗
• InjuryJan 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER FOR A 16 DAY OLD PATIENT WITH A WEIGHT OF 0.955KG FOR A PATENT DUCTUS ARTERIOSIS (PDA) WITH A MINIMAL DUCTUS DIAMETER OF 1.98MM AND A DUCTUS LENGTH OF 5.33MM. PRE-ECHOCARDIOGRAM VELOCITIES WERE MEASURED AS THE DESCENDING AORTA (DA) AT 1.89M/S AND THE LEFT PULMONARY ARTERY (LPA) AS 1.46M/S. THE DEFECT WAS MEASURED AS 8.24MM AT THE LARGEST DIAMETER ON THE AORTIC SIDE. ECHOCARDIOGRAM (ECHO) AND FLUOROSCOPY WAS USED FOR THE PROCEDURE. DURING THE PROCEDURE, WHEN THE OCCLUDER WAS PLACED INTRADUCTAL INTO THE PDA, VELOCITIES CHANGED 1.45M/S FOR THE LPA AND 2.2M/S FOR THE DA. NO RESIDUAL SHUNTS WERE OBSERVED. THE OCCLUDER WAS RELEASED FROM THE DELIVERY CABLE. POST-IMPLANT THE DELIVERY SHEATH APPEARED UNDER FLUOROSCOPY NEAR THE OCCLUDER. THE DELIVERY SHEATH WAS PULLED BACK AND THE OCCLUDER WAS OBSERVED TO HAVE MOVED SLIGHTLY TOWARDS THE LPA, CAUSING THE VELOCITY TO INCREASE TO 1.95M/S. FOUR ATTEMPTS WERE MADE TO SNARE THE OCCLUDER WITH A 8F NON-ABBOTT SNARE AND 4F NON-ABBOTT INTRODUCER SHEATH. THE WIRE POSITION WAS THROUGH THE RIGHT VENTRICULAR

  Patient problems: Arrhythmia; Bradycardia; Hypoxia; Pericardial Effusion

  MAUDE report 21137792 ↗
• InjuryNov 8, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A 3 WEEK OLD, 800G PATIENT TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). PATIENT WAS A 24-WEEK GESTATION PREMATURE INFANT. THE IMPLANT PROCEDURE WAS SUCCESSFUL. THE DEVICE WAS IMPLANTED IN THE INTRADUCTAL POSITION, AND THERE WAS NO EVIDENCE OF LEFT PULMONARY ARTERY (LPA) STENOSIS. ON ROUTINE ONE YEAR FOLLOW UP, A MILD INCREASE IN LPA VELOCITY WAS NOTED ON ECHOCARDIOGRAPHY. SUBSEQUENT FOLLOW UP SHOWED FURTHER INCREASE IN LPA VELOCITY SUGGESTIVE OF LPA STENOSIS. IN (B)(6) 2024, THE PATIENT WAS REFERRED FOR A LUNG PERFUSION SCAN, WHICH SHOWED 80% FLOW TO THE RIGHT PULMONARY ARTERY (RPA) AND 20% FLOW TO THE LPA. THE DECISION WAS MADE TO TAKE TO THE CATHETER LAB FOR ANGIOGRAPHIC ASSESSMENT OF THE LPA BLOOD FLOW. ON (B)(6) 2024, A BALLOON ANGIOPLASTY WAS PERFORMED ON THE LPA, WHICH WAS SUCCESSFUL IN RELIEVING THE LPA STENOSIS AND IMPROVING BLOOD FLOW TO THE LEFT LUNG. THE PEAK LPA GRADIENT DECREASED FROM 18MMHG TO 9MMHG, CONFIRMING A SATISFACTORY RESULT. IT WAS REPORTED THAT THE DEVICE LIKELY TILTED/MIGRATED FROM THE INTRADUCTAL POSITION TO AN EXTRADUCTAL POSITION WITH THE PROXIMAL DISK OF THE DEVI

  Patient problems: Obstruction/Occlusion

  MAUDE report 20644750 ↗
• DeathOct 14, 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 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 20 DAYS OLD PATIENT WITH A WEIGHT OF 642 GRAMS. THE PATIENTS CONDITION PRIOR TO IMPLANT WAS CRITICAL AND REQUIRED VENTILATORY SUPPORT ON AN OSCILLATOR, BUT STABLE PRIOR TO PROCEDURE. AN UMBILICAL VENOUS CATHETER AND AN UMBILICAL ARTERIAL CATHETER WAS PLACED AT TIME OF BIRTH. A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS ALSO PLACED ON (B)(6) 2024. THE PATIENT'S PDA MEASUREMENTS WERE: MINIMAL DIAMETER OF 3.3MM, DIAMETER AT AORTIC AMPULLA OF 5MM, AND LENGTH OF 9MM. THE DEVICE WAS ABLE TO BE SUCCESSFULLY IMPLANTED INTRADUCTALLY WITH NO ISSUES PRE-PROCEDURE, DURING PROCEDURE, OR POST-PROCEDURE. ON (B)(6) 2024, THE PATIENT HAD A BLOOD CULTURE PERFORMED AND REVEALED PSEUDOMONAS AERUGINOSA. ON (B)(6) 2024, THE PATIENT BECAME SYMPTOMATIC WITH HYPOTENSION, DESATURATIONS, RESPIRATORY DISTRESS, BRADYCARDIA, AND ENDED UP PASSING AWAY DUE TO SEPTIC SHOCK SECONDARY TO PSEUDOMONAS BACTEREMIA. THE PHYSICIAN COULDN'T DETERMINE WHETHER THE DEATH WAS RELATED TO THE IMPLANTED DEVICE. THE LAST ECHOCARDIOGRAM PRIOR TO DEATH DEMONSTRATED THE DEVICE TO BE IN GOOD POSITION WITH NO RESIDUAL F

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

  MAUDE report 20445736 ↗
• InjuryAug 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4/2 AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 5 WEEK OLD, 1.26KG PATIENT TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA) WITH THE FOLLOWING DIMENSIONS: LENGTH OF 10MM AND 2.9MM AT MINIMUM. DURING THE PROCEDURE, THERE WAS DIFFICULT OBTAINING ACCESS TO THE SITE WHICH WAS RESOLVED. THERE WAS AN ISSUE CANNULATING THE PDA BUT IT WAS EVENTUALLY CROSSED. AN ANGIOGRAM MEASURED THE PDA DIMENSIONS. THE PICCOLO OCCLUDER WAS DEPLOYED. AROUND THIS TIME, THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. IT WAS THOUGHT THAT THE DELIVERY SHEATH WAS TENTED OPEN WITH THE DEVICE BEING DEPLOYED BUT PRIOR TO RELEASE. THE DEVICE WAS RECAPTURED, AND THE BRADYCARDIA AND HYPOTENSION IMPROVED. ECHOCARDIOGRAM WAS THEN SET UP, AND PERICARDIAL EFFUSION WAS OBSERVED NEAR THE RIGHT ATRIUM. THE PATIENT WAS STABLE, AND THE DECISION WAS MADE TO DEPLOY THE DEVICE ONCE MORE. DURING SECOND DEPLOYMENT, THE PATIENT BECAME UNSTABLE ONCE AGAIN, AND THE DEVICE WAS REMOVED. CARDIAC TAMPONADE WAS PRESENT. A PERICARDIOCENTESIS WAS PERFORMED. AUTOTRANSFUSION WAS PERFORMED THROUGH THE DELIVERY SHEATH. THE PATIENT BECAME SEVERELY BRADYCARDIC, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS

  Patient problems: Bradycardia; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 19883091 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 28 MAY 2024, 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE USING A UNKNOWN DELIVERY SYSTEM FOR AN 4 WEEK OLD, 1.5 KG PATIENT. THE DEVICE WAS IMPLANTED, BUT A LEFT PULMONARY ARTERY (LPA) COMPRESSION WAS NOTED BY FLUOROSCOPY. THE PHYSICIAN SNARED THE DEVICE OUT. THERE WAS NO EMBOLIZATION NOTED. A NEW 3 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS A MINIMAL DELAY IN THE PROCEDURE BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570782 ↗
• MalfunctionMay 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 1.2KG, 33 WEEK OLD PATIENT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE DEVICE WAS IMPLANTED. THE FOLLOWING DAY AFTER IMPLANT, A SMALL RESIDUAL SHUNT WITH MILD LEFT PULMONARY ARTERY (LPA) OBSTRUCTION WAS OBSERVED VIA ECHOCARDIOGRAM (ECHO). THERE WAS NO NEGATIVE CLINICAL OUTCOMES FOR THE BABY AT PRESENT, ONLY ECHO FINDINGS BEING WATCHED. THE SHUNT CLOSED SPONTANEOUSLY POST-OPERATIVE DAY 23, AND THE PATIENT WAS REPORTED STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19265765 ↗
• InjuryAug 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 A AMPLATZER PICCOLO OCCLUDER 4 MM X 2 MM WAS IMPLANTED IN A PATIENT WITH A HISTORY OF CHRONIC LUNGS DISEASE. THE DUCT MEASUREMENTS WAS AO AMPULLA WAS 4.07 MM, 2.96 MM MID DUCT AT A RESTRICTION POINT, AND 3.54 MM AT LPA END WITH A TOTAL DUCTAL LENGTH OF 11.23 MM. THE DEVICE PLACED INTRADUCTAL. ON (B)(6) 2023, THE PATIENT PASSED AWAY DUE TO LUNG COMPLICATIONS, THE DEATH WAS NOT CAUSED BY THE PICCOLO. THE PHYSICIAN REPORTED THAT THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTED DEVICE OR ANY ABBOTT PRODUCT. THE PATIENT HAD CONSIDERABLE LUNG CHALLENGES PRIOR TO THE PICCOLO IMPLANT PROCEDURE AND FOLLOWING THE PLACEMENT OF THE PICCOLO DEVICE. THE PHYSICIAN STATED UNFORTUNATELY THE PATIENT FAILED TO IMPROVE POST RECEIPT OF THE PICCOLO DEVICE. THE PHYSICIAN ALSO STATED THERE WAS SOME GRADIENT IN THE LEFT PULMONARY ARTERY (LPA) POST PLACEMENT OF THE PICCOLO DEVICE. THE DEVICE WAS MAINLY FUNCTIONING AS INTENDED. HOWEVER, THE DEVICE DID PROTRUDE INTO THE LPA SLIGHTLY GIVEN THE IMPLANTING PHYSICIANS CONSIDERATION TO POTENTIALLY PERFORM A FUTURE INTERVENTION, BUT THE BABIES HEALTH DID NOT IMPROVE. THIS LPA GRADIENT CHANGE ON ECHOCARDIOGRAM WAS NOT SEEN UNTIL 3

  Patient problems: Adult Respiratory Distress Syndrome

  MAUDE report 17558754 ↗
• InjuryJul 17, 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 4-2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A 800KG PATIENT. THERE WAS NO REPORT OF ANY ADVERSE COMPLICATIONS DURING PROCEDURE. IT WAS LATER REPORTED ON (B)(6) 2023, MILD FLOW ACCELERATION WAS NOTED IN THE DESCENDING AORTA AT 2.6MSC. THE PATIENT STATUS WAS REPORTED AS STABLE IN THE NICU.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17336970 ↗
• InjuryMay 25, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 4 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A 980 GRAM PATIENT WITH THE FOLLOWING MEASUREMENT: PDA DIAMETER ON THE PULMONARY ARTERY END WAS 2.5 MM AND ON THE AORTIC END WAS 3.0 MM. THE OVERALL PDA LENGTH WAS 7.0 MM. THE PICCOLO DEVICE WAS POSITIONED WITHIN THE PDA. IT WAS NOTED THAT 19 DAYS POST-OPERATIVELY IT WAS NOTED THAT THE INFANT HAD FLOW ACCELERATION WITHIN THE AORTA WITH A DOPPLER VELOCITY OF 2.1 METER/SECOND. THE INFANT WAS TAKEN TO THE OPERATING ROOM WITH PLANS TO REMOVE THE DISC WHICH WAS PROTRUDING INTO THE AORTA; HOWEVER, DUE TO INTRA-OPERATIVE CONCERNS FOR BLEEDING A DECISION WAS MADE TO CLOSE THE INFANT AND NOT ATTEMPT TO REMOVE THE DISC. AT ONE-MONTH POST-IMPLANT THE INFANT REMAINS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED IN THE NEONATAL INTENSIVE CARE UNIT (NICU). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007568 ↗
• InjuryMay 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 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE DELIVERY SYSTEM AND A 4F NON-ABBOTT INTRODUCER. THE PATENT DUCTUS ARTERIOSUS (PDA) MINIMAL DIAMETER WAS MEASURED AS 1.6MM, THE PDA DIAMETER AT THE AORTIC AMPULLA WAS 4.5MM, AND THE PDA LENGTH WAS 5.6MM. THE DEVICE WAS PLACED INTRADUCTALLY, TESTED AND OPTIMALLY POSITIONED. AFTER IT WAS RELEASED, THE USER PUSHED THE OCCLUDER INTO THE AORTA WITH THE SHEATH. IT WAS REPORTED THAT 75% OF THE DEVICE REMAINED INSIDE THE DUCTUS BUT THE REMAINING 25% WAS PROTRUDING INTO THE AORTA. AFTER BEING PUSHED, THE OCCLUDER BLOCKED ARTERIAL FLOW AND THE PATIENT'S VITAL SIGNS WERE COMPROMISED. THE PATIENT'S OXYGENATION DECREASED, BLOOD PRESSURE INCREASED, AND THE PATIENT'S PULSE WAS NO LONGER FELT. A SNARE WAS USED TO EMERGENTLY CAPTURE THE OCCLUDER AND REMOVE IT FROM THE PATIENT. THE DELIVERY SHEATH AND INTRODUCER WERE REPLACED AND THE OCCLUDER WAS RELOADED. THE DEVICE WAS IMPLANTED WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: High Blood Pressure/ Hypertension; Hypoxia; Obstruction/Occlusion

  MAUDE report 16915837 ↗
• InjuryFeb 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL 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: Pneumothorax

  MAUDE report 16448445 ↗
• InjuryFeb 16, 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 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED IN A 6 WEEK, 1.6KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER 1.7 MM, LENGTH OF 9 MM, AND DIAMETER AT AORTIC AMPULLA OF 2.5 MM. IT WAS REPORTED THAT ON (B)(6) 2023, THAT THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY. THE DEVICE WAS EXPLANTED WITHOUT INCIDENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE EXPLANT PROCEDURE. THE PATIENT IS REPORTED TO BE RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384984 ↗
• InjuryOct 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 32 WEEK, 1.7KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER 2.6MM, LENGTH OF 9MM, AND DIAMETER AT AORTIC AMPULLA OF 3.4MM. THE DEVICE WAS PREPARED PER THE IFU AND IMPLANTED INTRADUCTALLY USING A 4F 60CM AMPLATZER TORQVUE LP DELIVERY SYSTEM. IT WAS OBSERVED DURING THE PROCEDURE THAT THE DEVICE MIGRATED SLIGHTLY AND THEN EMBOLIZED DOWN TO THE ABDOMINAL AORTA. THE DECISION WAS MADE TO EMERGENTLY REMOVE THE DEVICE BECAUSE IT CAUSED A GRADIENT IN THE AORTIC ARCH. THE PHYSICIAN THEN SUCCESSFULLY SNARED THE DEVICE AND REPLACED IT WITH ANOTHER 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER (8474507). TEMPORARY LOSS OF PERFUSION TO THE RIGHT FOOT WAS REPORTED AND HEPARIN WAS ADMINISTERED TO TREAT IT. THE PATIENT WAS REPORTED AS RECOVERED AND WAS DISCHARGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15611711 ↗
• InjurySep 2, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SIZED AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED. FOLLOWING THE PROCEDURE ON AN UNKNOWN DATE, A POSTERO-LATERAL THORACOTOMY WAS PERFORMED DUE TO IMPROPER DEVICE PLACEMENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15351144 ↗
• DeathJun 8, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER (8133391) WAS SELECTED FOR IMPLANT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). DURING PROCEDURE, THE DEVICE WAS NOT ABLE TO BE RELEASED FROM THE DELIVERY SYSTEM. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND ANOTHER 4MM X 2MM AMPLATZER PICCOLO OCCLUDER (8002426) WAS SUCCESSFULLY IMPLANTED. THERE WERE NO SIGNS OF OBSTRUCTION OF THE AORTA UPON ECHO EVALUATION AND DOPPLER MEASUREMENT. OVERNIGHT, THE DEVICE WAS DISCOVERED TO HAVE SHIFTED AND WAS CAUSING SEVERE OBSTRUCTION OF THE DESCENDING AORTA. THE DEVICE WAS REMOVED SURGICALLY ON (B)(6)2022. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 14636295 ↗
• DeathMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING CONSERVATIVELY REPORTED AS THE CAUSE OF DEATH AND ITS RELATIONSHIP TO THE IMPLANT PROCEDURE AND/OR DEVICE REMAINS UNKNOWN. IT WAS REPORTED THAT ON 27 APR 2022, A 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT FOR A (B)(6) PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: MINIMAL DIAMETER 2.4MM, LENGTH OF 12.2MM AND DIAMETER AT AORTIC AMPULLA OF 2.7MM. THE DELIVERY SYSTEM USED WAS A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON VENTILATORY SUPPORT AND ON INTRAVENOUS (IV) SUPPORT. DURING THE PROCEDURE, THE DEVICE WAS PLACED INTRADUCTAL, AND THE RESULTS WERE SATISFACTORY DURING BOTH ECHOCARDIOGRAPHY AND ANGIOGRAPHY. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE. ONLY HEPARINIZED SALINE WAS USED IN THE PROCEDURE, AND NO HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS RELEASED, AND THE DELIVERY SYSTEM WAS REMOVED. THE PATIENT THEN BEGAN TO DECOMPENSATE WITH LOW BLOOD PRESSURE AND BRADYCARDIA. THE PATIENT WAS ADMINISTERED MEDICATION SUPPORT, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT WAS NOTED TO HAVE A NEW PERICARDIAL EFFUSION, AND THE EFFUSION WAS RELIEV

  Patient problems: Bradycardia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 14520353 ↗
• InjuryJun 16, 2021Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device; Obstruction of Flow

  IT WAS REPORTED THAT ON (B)(6) 2021, A 4/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) DAY OLD (B)(6) KG PATIENT THAT WAS CRITICALLY ILL WITH RESPIRATORY FAILURE AND RENAL INSUFFICIENCY. THE PATIENT HAD THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 2.4MM, PDA LENGTH OF 8.2MM AND DIAMETER AT AORTIC AMPULLA OF 3.3MM. DURING THE PROCEDURE THE DEVICE WAS SUCCESSFULLY PLACED INTRADUCTALLY NEAR THE AORTIC END OF THE PDA WITHOUT IMPINGEMENT ON THE PULMONARY ARTERY (PA) OR AORTA. 5 DAYS POST IMPLANT, THE PATIENT PRESENTED WITH SYMPTOMATIC AORTIC OBSTRUCTION, LEFT VENTRICLE (LV) DYSFUNCTION, AND RENAL FAILURE. THE PATIENT WAS TAKEN BACK TO THE CATH LAB AND IT WAS FOUND THAT THE DEVICE HAD MIGRATED SUCH THAT THE AORTIC DISC AND PART OF CENTRAL DISC WERE PUSHING INTO AORTA, NOT ALLOWING FOR THE USE OF A STENT. THE DEVICE COULDN'T BE REMOVED OR COARCTATION STENTED BY TRANSCATHETER APPROACH, SO DEVICE WAS REMOVED SURGICALLY. THE PDA WAS LIGATED AND THE AORTA REPAIRED. NO RESIDUAL PDA OR COARCTATION WAS NOTED BY ECHO POST PDA DEVICE REMOVAL. THE PATIENT IS RECOVERING BUT IS CRITICALLY ILL, AS THEY WERE PRIOR TO THE PROCEDURE. NO ADDITIONAL I

  Patient problems: Foreign Body Embolism; Obstruction/Occlusion; Pulmonary Dysfunction; Renal Failure

  MAUDE report 12013548 ↗
• InjuryJun 15, 2021Obstruction of Flow; Material Deformation; Migration; Obstruction of Flow; Material Deformation; Migration

  ON (B)(6) 2021, A 4/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A CRITICALLY ILL (B)(6) DAY OLD (B)(6) KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 1.9MM, PDA LENGTH OF 7.3MM AND DIAMETER AT AORTIC AMPULLA OF 3.5MM. DURING THE PROCEDURE, DESPITE THE DEVICE BEING APPROPRIATELY SIZED, THE PATIENT EXPERIENCED AORTIC IMPINGEMENT ON MULTIPLE DEVICE DEPLOYMENTS. AORTIC IMAGING BY ULTRASOUND WAS EXTREMELY LIMITED DUE TO POOR ECHO WINDOWS. ON THE FINAL IMPLANT ATTEMPT THE DEVICE WAS SUCCESSFULLY POSITIONED WITH NO EVIDENCE OF IMPINGEMENT ON ECHO OR BY LOWER EXTREMITY ARTERIAL LINE WAVEFORMS, DESPITE THE PULMONARY ARTERY (PA) END OF THE DEVICE BEING MODERATELY DEFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. POST PROCEDURE IMAGING WAS THEN PERFORMED AND SHOWED NO EVIDENCE OF AORTIC IMPINGEMENT. 5 DAYS LATER, THE PATIENT DEVELOPED RENAL INSUFFICIENCY AND ANURIA. ECHO WAS PERFORMED AND SHOWED SIGNIFICANT DEVICE IMPINGEMENT OF THE AORTA. FURTHER IMAGING PERFORMED REVEALED THAT THE AORTIC DISC WAS EXTENDING INTO THE AORTA. IT WAS THEN DECIDED TO PLACE A 3.5 MM CORONARY STENT WHICH SUCCESSFULLY RELIEVED THE AORTIC

  Patient problems: Renal Impairment

  MAUDE report 12005207 ↗

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