AMPLATZER™ 9-ITV09F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00811806010861), received between Jul 17, 2018 and Sep 25, 2026 — classified as 2 deaths, 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fluid/Blood Leak; Fracture

  It was reported that on (b)(6)026, a 9F Amplatzer TorqVue Delivery System was chosen for a procedure. During procedure, it was noted that the three-way valve is leaking saline. There was Less than 200 mL leak at the connector joint of the delivery system. There was a crack at the joint. The patient remained hemodynamically stable throughout the procedure and there was no delay in the procedure. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897212 ↗
• MalfunctionDec 30, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER PATIENT CONTACT, WHEN EVACUATING AIR FROM THE OCCLUDER AND THE DELIVERY SHEATH, IT WAS OBSERVED THAT THE EXTENSION TUBE CONNECTING 2-WAY STOPCOCK HAD CRACKED AND WAS LEAKING SALINE IN A CONTINUOUS DRIP. NO OTHER PARTS OF THE DELIVERY SYSTEM WAS OBSERVED TO BE DAMAGED. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923600 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771314 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER INSERTING INTO THE PATIENT AND WHEN EVACUATING AIR FROM THE OCCLUDER AND DELIVERY SYSTEM, IT WAS DISCOVERED THAT THE EXTENSION TUBE CONNECTING 2-WAY STOPCOCK HAD CRACKED AND WAS LEAKING SALINE IN A CONTINUOUS DRIP. THE EXTENSION TUBE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN HEALTHY CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649730 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER PATIENT CONTACT, "WHEN EVACUATING AIR FROM THE OCCLUDER AND THE DELIVERY SHEATH, IT WAS DISCOVERED THAT THE EXTENSION TUBE CONNECTING 2-WAY STOPCOCK OF THE DELIVERY SYSTEM HAD CRACKED AND WAS LEAKING FLUID"; THE SYSTEM WAS REPORTEDLY LEAKING SALINE IN A CONTINUOUS DRIP. "THE EXTENSION CATHETER WAS REPLACED BY THE PHYSICIAN, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED." THE PATIENT WAS REPORTED TO BE IN HEALTHY CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596309 ↗
• MalfunctionOct 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO PARTS OF THE DELIVERY SYSTEM WERE OBSERVED TO BE DAMAGED. DURING USE AFTER INSERTION INTO THE PATIENT, WHEN EVACUATING AIR FROM THE OCCLUDER AND THE SHEATH, IT WAS DISCOVERED THAT THE EXTENSION TUBE CONNECTING THE 2-WAY STOPCOCK HAD CRACKED AND WAS LEAKING SALINE IN A CONTINUOUS DRIP. THE EXTENSION TUBE WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN HEALTHY CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23237571 ↗
• MalfunctionSep 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, THE EXTENSION TUBE BETWEEN THE Y-VALVE AND THE SWITCH WAS OBSERVED TO BE CRACK AND WAS LEAKING WATER IN A CONTINUOUS DRIP. THE DELIVERY SYSTEM WAS NEVER INTRODUCED INTO THE PATIENT AND EXCHANGED FOR A NEW 9F AMPLATZER TORQVUE DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23156914 ↗
• MalfunctionSep 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. THE DELIVERY SYSTEM WAS INSPECTED PRIOR TO USE. HOWEVER, WHILE EVACUATING AIR FROM THE OCCLUDER AND DELIVERY SHEATH AFTER INSERTION INTO THE PATIENT, IT WAS DISCOVERED THAT THE EXTENSION TUBE CONNECTING THE 2-WAY STOPCOCK WAS CRACKED AND WAS LEAKING SALINE IN A CONTINUOUS DRIP. THE EXTENSION TUBE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151738 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON 16 JUL. 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM (DS) WAS SELECTED FOR IMPLANT. IT WAS NOTICED THAT THERE WAS SALINE LEAKING OUT OF THE TRANSMISSION AND SWITCHING SYSTEM. IT WAS NOTED THAT THERE WAS A CRACK AT ONE OF THE CONNECTIONS. THE DEVICE NEVER MADE CONTACT WITH THE PATIENT. THE DS WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750110 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE DELIVERY SYSTEM WAS INSPECTED PRIOR TO USE. DURING IMPLANT, WHILE EVACUATING AIR FROM THE OCCLUDER AND DELIVERY SHEATH, IT WAS OBSERVED THAT THE THREE-WAY VALVE OF THE DELIVERY SYSTEM WAS CRACKED AND WAS LEAKING FLUID. THE LOCATION OF THE LEAK WAS AT THE EXTENSION PIPE UNDER THE THREE-WAY VALVE. NO OTHER DAMAGERS WERE OBSERVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097451 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM (DS) WAS SELECTED FOR USE IN AN OCCLUDER IMPLANT PROCEDURE. DURING THE PROCEDURE, THE DS BROKE DURING THE DELIVERY OF THE OCCLUDER. THE OCCLUDER WAS ABLE TO BE SUCCESSFULLY IMPLANT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001968 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TORQVUE WAS CHOSEN FOR USE IN A PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE THREE-WAY VALVE OF THE DELIVERY SYSTEM HAD CRACKED AND WAS LEAKING FLUID. THE DEVICE NEVER ENTERED THE PATIENT ANATOMY. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909920 ↗
• MalfunctionMar 28, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT (B)(6) 2025, AN 8F AMPLATZER TORQVUE 45/80 WAS UTILIZED DURING A PROCEDURE. WHEN ADVANCING THROUGH THE ANATOMY THERE WAS ADVANCEMENT DIFFICULTY AND THE BLUE TIP BECAME DAMAGED. A REPLACEMEN T 9F AMPLATZER TORQVUE WAS ATTEMPTED TO BE USED AS A REPLACEMENT BUT ALSO MET RESISTANCE WHILE ADVANCING WHICH DAMAGED THE BLUE TIP. A NON-ABBOTT REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723462 ↗
• MalfunctionSep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. THE DELIVERY SYSTEM (DS) WAS INSPECTED PRIOR TO USE. DURING PROCEDURE, THE TRANSMISSION SYSTEM AND THE SWITCHING SYSTEM WERE OBSERVED TO BE LEAKING SALINE AT THE TRIPLE VALVE. THERE WAS NOT A SIGNIFICANT AMOUNT OF LEAKAGE. NO PARTS OF THE DS WERE OBSERVED TO BE DAMAGED. A NEW 9F AMPLATZER TORQVUE DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207384 ↗
• MalfunctionJun 28, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS UNDER CONSCIOUS SEDATION. DURING PROCEDURE, THE DELIVERY SYSTEM WAS PUT INTO THE BODY. AFTER THE SHEATH ENTERED THE BODY, THE INNER CORE WAS WITHDRAWN. THE AMPLATZER PFO OCCLUDER WAS LOADED. THE OUTER SHEATH WAS CONNECTED TO THE SYRINGE TO CONTAIN PHYSIOLOGICAL SALINE. THE CONNECTORS WERE ALL TIGHTLY CONNECTED. WHEN THE SYRINGE WAS WITHDRAWN, AIR LEAKAGE WAS FOUND IN THE SHEATH. NO AIR WAS VISUALIZED IN THE PATIENT. THE PHYSICIAN BELIEVED THAT THE SHEATH CONNECTION WAS NOT AIR TIGHT. THE GUIDEWIRE WAS EXCHANGED. THE DELIVERY SYSTEM WAS REPLACED WITH ANOTHER 9F AMPLATZER TORQVUE DELIVERY SYSTEM. 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 AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638998 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS REMOVED DUE TO MIS-SIZING. THE DEVICE NEVER RELEASED FROM THE CABLE. A NEW 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, PRIOR TO DISCHARGE, ANEMIA AND HEMATOMA AT GROIN WAS CONFIRMED, MANUAL COMPRESSION WAS CONDUCTED. ON (B)(6) 2020, BLOOD TRANSFUSION WAS CONDUCTED. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE ON (B)(6), 2020. THE PHYSICIAN MENTIONED THE ISSUE WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS REPORTED DISCHARGED FROM THE HOSPITAL WITHOUT SEQUELAE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Anemia; Hematoma

  MAUDE report 19055551 ↗
• MalfunctionDec 4, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS UNDER LOCAL ANESTHESIA. DURING PROCEDURE, THE OCCLUDER WAS LOADED INTO THE DELIVERY SYSTEM AND THE DELIVERY SYSTEM WAS INTRODUCED TO THE PATIENT AND DELIVERED INTO THE LEFT UPPER PULMONARY VEIN. THE INNER CORE WAS WITHDRAWN AND CONNECTED TO THE LOADER IMMEDIATELY AFTER REMOVAL OF THE DILATOR AT NORMAL SPEED WHEN IT WAS NOTED AIR BUBBLES WERE VISUALIZED IN THE BLOOD FLOW IN THE DELIVERY SYSTEM. A DECISION WAS MADE TO USE A SYRINGE TO CONTINUOUSLY DISCHARGE THE BUBBLES. IT WAS REPORTED THAT CONSTANT ASPIRATION WAS BEING PERFORMED ON THE VALVE SIDE HOLE. A CONTINUOUS SALINE FLUSH WAS ATTACHED TO THE LOADER. IT WAS REPORTED ALL THE CONNECTORS WERE TIGHTLY CONNECTED BUT AIR LEAKAGE WAS FOUND IN THE DELIVERY SYSTEM. AFTER REMOVAL OF AIR BUBBLES, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND REPLACED WITH A SECOND 9F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS REPORTED THE 25MM OCCLUDER WAS SUCCESSFULLY IMPLANTED WITH THE REPLACEMENT DELIVERY SYSTEM. THE PATIENT STATUS WAS REPORTED AS STABLE AND THERE WAS NO REPORT OF ANY ADVERSE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257855 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQUE DELIVERY SYSTEM. THE PATIENT WAS CONSCIOUSLY SEDATED FOR PROCEDURE. ALL COMPONENTS (HEMOSTASIS VALVE, 25MM AMPLATZER (PFO) OCCLUDER, LOADER, DILATOR ETC.) WERE FLUSHED WITH STERILE SALINE AS PER THE INSTRUCTIONS FOR USE. IT WAS NOTED VIA ELECTROCARDIOGRAM, THAT DURING PROCEDURE THAT THE PATIENT EXPERIENCED AN ST ELEVATION PRIOR TO THE DEPLOYMENT OF THE LEFT ATRIAL DISC OF THE OCCLUDER. THE DILATOR HAD BEEN REMOVED SLOWLY TO PREVENT AIR INGRESS. THERE WAS ASPIRATION BEING DONE PRIOR TO, OR AFTER NOTING THE ST ELEVATION. THERE WAS NO CONTRAST INJECTED. THE PATIENT'S ST ELEVATION WAS TREATED WITH OXYGEN AND AN AIR EMBOLISM WAS SUSPECTED. THE 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SUCCESSFULLY IMPLANTED WITHOUT DIFFICULTY. THERE WAS NO LEAK OBSERVED/DISCOVERED IN THE 9F AMPLATZER TORQUE DELIVERY SYSTEM. IT WAS ALSO NOTED VIA ELECTROCARDIOGRAM, THAT DURING PROCEDURE THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND FURTHER DEVELOPED INTO A HEART BLOCK. THE DECISION WAS MADE TO ADMINISTER AMIODARONE IN AN ATTEMPT TO RETURN THE PATIENT

  Patient problems: Air Embolism; Atrial Fibrillation; Heart Block; Non specific EKG/ECG Changes

  MAUDE report 16472703 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR A PFO CLOSURE PROCEDURE, ALONG WITH A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS SIZED AND SUCCESSFULLY IMPLANTED USING MICRO-TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THERE WERE NO COMPLICATIONS NOTED DURING THE IMPLANT PROCEDURE. DURING THE NIGHT AFTER THE IMPLANTATION, THE PATIENT WOKE UP AND HAD BLOOD ON THE FEMORAL COMPRESSION AT THE ACCESS SITE OF THE DELIVERY SYSTEM FROM THE PROCEDURE. THE PATIENT BECAME BRADYCARDIC, AND THE PHYSICIAN SUSPECTED THAT THE PATIENT BECAME BRADYCARDIC FROM THE SIGHT OF THE BLOOD. THE CAUSE OF THE FEMORAL BLEEDING WAS UNKNOWN, AND IT IS UNKNOWN HOW MUCH FEMORAL BLEEDING WAS PRESENT. FEMORAL COMPRESSION WAS PERFORMED TO TREAT THE BLEEDING. THE PHYSICIAN GAVE THE PATIENT A STERNAL PUNCH TO TREAT THE BRADYCARDIA, AND THE PATIENT RECOVERED. THE NEXT DAY, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WERE PERFORMED. THE LEFT DISC OF THE DEVICE WAS WELL APPOSED IN THE LEFT ATRIUM, BUT THE RIGHT DISC WAS PARTIALLY IN THE RIGHT ATRIUM AND PARTIALLY IN THE PFO. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13452552 ↗
• DeathJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 14MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM FOR A HIGH RISK, POST MYOCARDIAL INFRACTION (MI) VSD CLOSURE ON (B)(6) 2021. THE (B)(6) YEAR OLD PATIENT HAD A VSD THAT WAS MEASURED VIA COMPUTERIZED TOMOGRAPHY (CT), TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND LEFT VENTRICULAR (LV) ANGIOGRAPHY. THE DEFECT MEASUREMENT WAS ABOUT 10-11MM. THE DELIVERY SYSTEM WAS PLACED IN THE INTERNAL JUGULAR (IJ) ACCESS SITE. PRIOR TO DEPLOYMENT, A SMALL PERICARDIAL EFFUSION AND A DROP IN THE PATIENT'S PRESSURES WERE OBSERVED ON ECHOCARDIOGRAM (ECHO). THE DEVICE WAS ATTEMPTED TO BE PLACED, HOWEVER WAS DEEMED TOO SMALL. THE PATIENT DEVELOPED TAMPONADE AND THE OCCLUDER WAS RE-SHEATHED AND REMOVED FROM THE PATIENT. PERICARDIOCENTESIS WAS PERFORMED. IT WAS BELIEVED THAT THE PERICARDIAL EFFUSION OCCURRED WHILE GAINING ACCESS AND CROSSING THE DEFECT. THE PATIENT'S RHYTHM CHANGED AND BECAME UNSTABLE. IT WAS NOTED THAT THE PATIENT WAS SHOCKED SEVERAL TIMES. AN 18MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS THEN ATTEMPTED TO BE IMPLANTED USING THE SAME DELIVERY SYSTEM AND PLACED APPROPRIATELY WITHIN

  Patient problems: Arrhythmia; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 12088476 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2135147-2021-00176. ON AN UNKNOWN DATE, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, AS THE LOADER WAS BEING CONNECTED TO THE DELIVERY SHEATH, AN AIR EMBOLISM WAS OBSERVED OVER THE DELIVERY SHEATH AND REQUIRED ASPIRATION FROM THE RIGHT CORONARY ARTERY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POST-PROCEDURE. IN THE ICU, AN INTRACEREBRAL EVENT/STROKE WAS OBSERVED AND THE PATIENT WAS MONITORED. THE PATIENT WAS REPORTED HAVE BEEN DISCHARGED IN STABLE CONDITION TO RECEIVE REHABILITATION FOR THE STROKE.

  Patient problems: Air Embolism

  MAUDE report 11871094 ↗
• InjuryAug 3, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020, A 18MM AMPLATZER SEPTAL OCCLUDER(ASO) WAS SELECTED FOR IMPLANT IN THE PATIENT AFTER MEASURING THE SIZE WITH A SIZING BALLOON. DURING THE PROCEDURE THE ASO WAS ATTEMPTED TO BE IMPLANTED, BUT THE PHYSICIAN DECIDED THAT THE ASO WAS UNDER-SIZED. THROMBUS HAD FORMED IN THE PATIENT AND ADHERED TO THE DELIVERY CABLE DURING THE PROCEDURE. THE PHYSICIAN WAS CONCERNED ABOUT THE THROMBUS ADHERING ON THE DELIVERY CABLE AND DECIDED TO REMOVE THE 18MM ASO AND THE 9F 45/80 AMPLATZER TORQVUE DELIVERY SYSTEM FROM THE PATIENT. THE DEVICES WERE REPLACED WITH A 20MM AMPLATZER SEPTAL OCCLUDER(ASO) AND A 10F 45/80 AMPLATZER TORQVUE DELIVERY SYSTEM TO CONTINUE THE PROCEDURE. THE 20MM ASO WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT TOOK TIME IN THE ATTEMPT TO DEPLOY THE FIRST 18MM ASO IN THE PATIENT'S DEFECT, SO THE DELIVERY CABLE AND THE SHEATH WERE IN THE PATIENT LONGER THAN USUAL PROCEDURES. HOWEVER, THE DELAY WAS NOT SIGNIFICANT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 10359962 ↗
• InjuryMar 15, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020, A 25MM AMPLATZER PFO WAS SELECTED FOR IMPLANT. THE DEVICE WAS MIS-SIZED TOO SMALL DUE TO THE PATIENT'S ANATOMY. THE DEVICE WAS EXCHANGED FOR A 30MM AMPLATZER PFO. AFTER INTRODUCING THE 30MM DEVICE, SELF-LIMITING TRANSIENT ECG-CHANGES OCCURRED. IT WAS SUSPECTED THAT AN AIR-EMBOLISM CAUSED THE ECG-CHANGES. AFTER COMPLETING THE PFO PROCEDURE, A DIAGNOSTIC CORONARY INTERVENTION WAS PERFORMED TO EXCLUDE AN AIR EMBOLISM IN THE CORONARIES, IN WHICH IT RESULTED IN NORMAL RESULTS. THE ECG-CHANGE RESOLVED WITHOUT INTERVENTION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT AND THE CORONARY INTERVENTION AFTERWARDS.

  Patient problems: Air Embolism

  MAUDE report 9833205 ↗
• InjuryDec 6, 2019Biocompatibility; Biocompatibility

  ON (B)(6) 2019, A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED. WHILE CONNECTING THE LOADER TO THE DELIVERY SHEATH, THE PATIENT SPONTANEOUSLY TOOK A DEEP BREATH WHICH CAUSED AIR EMBOLISM, WHICH WAS SUSPECTED DUE TO ECG CHANGES. THE PATIENT HAD ST-ELEVATION, CARDIAC ARREST AND WAS TREATED WITH LEFT HEART CATHERIZATION AND STABILIZED WITH MEDICATION. THE DEVICE WAS IMPLANTED AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT WAS REFERRED TO COMPUTED TOMOGRAPHY (CT) SCAN, WHICH REVEALED HEMORRHAGIC STROKE AND WAS SENT TO FURTHER TREATMENT TO A STROKE CENTER. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Air Embolism; Cardiac Arrest; Intracranial Hemorrhage; ST Segment Elevation

  MAUDE report 9423965 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, AN 18MM AMPLATZER CRIBRIFORM SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHEN THE DILATOR WAS WITHDRAWN FROM THE SHEATH, THE PHYSICIAN NOTICED A THROMBUS. THE PHYSICIAN PROCEEDED TO INSERT THE DELIVERY CABLE, AND A SECOND THROMBUS WAS SEEN ON THE DISTAL DISC WHEN DEPLOYED. THE CASE WAS ABANDONED AND THE PATIENT WAS PLACED ON ANTICOAGULANTS AND IS BEING MONITORED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Thrombus

  MAUDE report 8647885 ↗