Amplatzer™ PFO Occluder (REF 9-PFO-035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00811806011301), received between Aug 27, 2018 and Aug 21, 2025 — classified as 1 death, 33 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR PROCEDURE USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE DEPLOYMENT, AN ABNORMAL EXPANSION WAS OBSERVED AT THE WAIST OF THE DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE OPERATION WAS SUCCESSFUL AND THE PATIENT WAS REPORTED HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865897 ↗
• MalfunctionJan 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 35MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. THE OCCLUDER WAS IMPLANTED. NO LEAK WAS NOTED. ON (B)(6) 2024 DURING A FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) THE PATIENT PRESENTED WITH A POSITIVE BUBBLE TEST USING THE VALSALVA METHOD. A GRADE 2-3 LEAK WAS PRESENT. NO INTERVENTION WAS REQUIRED. PER THE PHYSICIAN, THE OCCLUDER MAY NOT HAVE ENDOTHELIALIZED FULLY AT THE TIME OF THE TTE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242427 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - PFO OCCLUDER PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED ON (B)(6) 2020, IT WAS NOTED THAT PATIENT'S LOOP RECORDER WAS INTERROGATED AND REVEALED THAT THE PATIENT HAD EPISODES OF RAPID ATRIAL FIBRILLATION. THE LONGEST OF ATRIAL FIBRILLATION WAS 14 HOURS. THE DECISION WAS MADE TO START THE PATIENT ON CARDIZEM AND CONTINUE THEIR ELIQUIS.

  Patient problems: Atrial Fibrillation

  MAUDE report 20216552 ↗
• InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) - PFO JAPAN PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER AND 10F AMPLATZER TORQVUE DELIVERY SYSTEM WERE SELECTED FOR PROCEDURE. THE PATIENT WAS CONSCIOUSLY SEDATED FOR PROCEDURE. THE PATIENT WAS ADMINISTERED 8000 UNITS OF HEPARIN FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE USING UNKNOWN IMAGING, THAT THERE WAS A THROMBUS NOTED WITHIN THE 10F DELIVERY SYSTEM, ADHERING THE DISC OF THE OCCLUDER. THE DECISION WAS MADE TO REMOVE THE 10F AMPLATZER TORQVUE DELIVERY SYSTEM AND 35MM AMPLATZER (PFO) OCCLUDER AND REPLACE THEM. A REPLACEMENT 35MM AMPLATZER (PFO) OCCLUDER WAS PREPARED AND SUCCESSFULLY IMPLANTED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19960701 ↗
• MalfunctionJul 5, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, RIGHT DISK OF FORAMEN OVALE OCCLUDER EXPANDS.DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. DEVICE WAS REPLACED WITH A NEW 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683075 ↗
• MalfunctionMay 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, THE FIRST DISC DEPLOYED WELL, BUT AFTER THE SECOND DISC WAS DEPLOYED THE FIRST DISC DEFORMED INTO A LOTUS SHAPE. THE PHYSICIAN TRIED LIGHT TUGGING TO RETURN THE DEVICE TO A NORMAL CONFIRMATION, BUT WHILE ATTEMPTING THE SECOND DISC THEN STARTED TO DEFORM INTO A CONICAL SHAPE. THERE WAS NO KINK/ANGULATION IN THE DELIVERY SYSTEM OR INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PHYSICIAN RECAPTURED AND REMOVED THE DEVICE AND THEN REPLACED IT WITH A NEW 35MM AMPLATZER PFO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WENT SMOOTHLY WITHOUT ANY ADVERSE EVENTS OR DELAYS. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19424037 ↗
• InjuryApr 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A 35MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS PRESCRIBED ASPIRIN PRE-PROCEDURE AND CONTINUED TAKING POST-PROCEDURE. NO ANTICOAGULANT AGENT WAS PRESCRIBED BUT ANTIPLATELET MEDICATIONS WERE. ON (B)(6) 2020, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THE PATIENTS D-DIMER VALUES WERE INCREASING SO A CT WAS PERFORMED. ON (B)(6) 2021, A DEEP VEIN THROMBOSIS (DVT) WAS DIAGNOSED BY INTERPRETATION. LIXIANA/EDOXABAN AND ASPIRIN WERE CONTINUED UNTIL (B)(6) 2021. ON (B)(6) 2021, TEE WAS PERFORMED AND NOTED THAT SHUNTING HAD IMPROVED SIGNIFICANTLY, BUT SOME WAS STILL PRESENT. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON 23 (B)(6) 2021. IT IS SPECULATED THAT THE CAUSE OF THE THE DVT WAS DUE TO PROLONGED TIME IN THEIR HOSPITAL BED. THERE IS NO ALLEGATION AGAINST THE ABBOTT DEVICE OR IMPLANT PROCEDURE. ON (B)(6) 2021, A TTE WAS PERFORMED AND SHOWED THAT THERE WAS NO SHUNTING.

  Patient problems: Cardiac Enzyme Elevation; Thrombosis/Thrombus

  MAUDE report 19213871 ↗
• MalfunctionApr 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 16 MARCH 2024, A 30MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEVICE PREPARATION, THERE WERE SLIGHT WEAVES OF THREAD COMING OFF THE DEVICE. BOTH THE DEVICE AND DELIVERY SYSTEM WERE EXCHANGED. A 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE FIRST DISC OF THE DEVICE DEPLOYED WELL. SUBSEQUENTLY, THERE WAS A DISC BULGING FORMATION AFTER THE SECOND DISC WAS DEPLOYED. THE DEVICE CONTINUOUSLY SHOWED BULGING AFTER WIGGLING AND LIGHT TUGGING. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK IN THE DELIVERY SYSTEM. OUTSIDE OF THE PATIENT, THE DEVICE WAS UNABLE TO REGAIN ITS EXPECTED SHAPE. A NEW 35MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. 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 19073069 ↗
• MalfunctionJun 29, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING PROCEDURE, HEPARIN WAS ADMINISTRATED, AND THE ACTIVATED CLOTTING TIME (ACT) LEVELS OF THE PATIENT WAS 372. IT WAS NOTED THAT THE PATIENT'S HEART WAS ROTATED. IT WAS DIFFICULT TO CROSS THE SEPTUM DURING THE TRANSEPTAL PUNCTURE DUE TO THE PATIENT ANATOMY. AFTER THE DEVICE WAS DEPLOYED, THE RIGHT ATRIAL (RA) DISC OF THE OCCLUDER WAS NOT FLATTEN AND HAD A BULBOUS DEFORMATION. THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE AND THE DISC WAS FLATTED, CONFIRMED IN FLUOROSCOPY. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. AFTER THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE, AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED. PATIENT STAYED OVERNIGHT DUE TO PERICARDIOCENTESIS. THE PHYSICIAN MENTIONED PERICARDIAL EFFUSION WAS NOT RELATED TO OCCLUDER AND IT WAS CAUSED BY ONE OF THE NON-ABBOTT WIRES WHILE ATTEMPTING TO CROSS THE SEPTUM. THE PATIENT

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 17226207 ↗
• InjuryJun 22, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, A 35MM AMPLATZER PFO OCCLUDER WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, A ROUTINE ECHOCARDIOGRAM SHOWED THE DEVICE HAD EMBOLIZED INTO PULMONARY ARTERY. DEVICE WAS SUCCESSFULLY CAPTURED USING A 22 FRENCH SHEATH AND A SNARE. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17179108 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_806 - PFO OCCLUDER PAS, PATIENT SITE ID: (B)(6), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM AMPLATZER PFO OCCLUDER WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, THE PATIENT HAD AN ARRHYTHMIA. ON (B)(6) 2023, SUDDEN ONSET ATRIAL FIBRILLATION WAS FOUND BY ELECTROCARDIOGRAM (EKG) AND THE PATIENT UNDERWENT ELECTRICAL CARDIOVERSION UNDER SEDATION. ANOTHER EKG WAS PERFORMED AND THE PATIENT WAS IN SINUS RHYTHM. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16763157 ↗
• MalfunctionMar 28, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632120 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_806 - PFO OCCLUDER PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM PFO OCCLUDER WAS IMPLANTED INTO A PATIENT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENTS ACT LEVEL WAS 293 SECONDS DURING THE PROCEDURE. AFTER THE PROCEDURE, PRIOR TO BEING TRANSFERRED TO RECOVERY, THE PATIENT STARTED BECOMING HYPOTENSIVE. ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION PROGRESSED INTO A CARDIAC TAMPONADE. PROTOMINE WAS ADMINISTERED AND ACT DECREASED TO 107 SECONDS. PERICARDIOCENTESIS PERFORMED. THE PATIENT WAS REPORTED TO BE DISCHARGED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16390230 ↗
• MalfunctionFeb 2, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS PREPARED PER THE IFU. AFTER THE DEVICE WAS POSITIONED, THE DEVICE WAS DEPLOYED BUT THE RIGHT DISC WOULD NOT FLATTEN OUT. IT WAS REPORTED THAT THE RIGHT DISC WAS BULBOUS IN SHAPE AND RESEMBLED A HAMBURGER. THERE WAS NO NOTICED PROBLEM WITH THE LEFT DISC. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A SECOND 35MM AMPLATZER PFO OCCLUDER WAS THEN CHOSEN FOR IMPLANT USING THE SAME 10F DELIVERY SYSTEM. AFTER THE REPLACEMENT DEVICE WAS RELEASED FROM THE DELIVERY CABLE, A SMALL SPACE HAD FORMED BETWEEN THE RIGHT DISC AND THE SEPTUM RESULTING IN A SMALL AMOUNT OF BLOOD FLOW IN BETWEEN THE RIGHT DISC AND THE SEPTUM. HOWEVER, IT WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THE PFO WAS COMPLETELY CLOSED, AND THE DEVICE WAS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287203 ↗
• MalfunctionJan 24, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THERE WERE ATTEMPTS TO RECAPTURE AND REDEPLOY THE OCCLUDER, BUT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 35MM AMPLATZER (PFO) OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE, BUT THE REPLACEMENT ALSO EXHIBITED A COBRA DEFORMATION. THE REPLACEMENT 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS THEN REMOVED AND REPLACED BY A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237683 ↗
• MalfunctionJan 23, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THERE WERE ATTEMPTS TO RECAPTURE AND REDEPLOY THE OCCLUDER, BUT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 35MM AMPLATZER (PFO) OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE, BUT THE REPLACEMENT ALSO EXHIBITED A COBRA DEFORMATION. THE REPLACEMENT 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS THEN REMOVED AND REPLACED BY A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224697 ↗
• MalfunctionDec 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM AMPLATZER PFO WAS SELECTED FOR AN IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER EXPANDED AND ITS SHAPE WAS ABNORMAL. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. DEVICE WAS REPLACED WITH A NEW 35MM AMPLATZER PFO THAT WAS SUCCESSFULLY IMPLANTED. PATIENT STABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905514 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED THAT DURING PROCEDURE THERE WAS DIFFICULTY EXPERIENCED DEPLOYING THE RIGHT ATRIAL DISC OF THE 25MM AMPLATZER PFO OCCLUDER INTO THE RIGHT ATRIUM. MULTIPLE DEPLOYMENT ATTEMPTS WERE MADE TO TRY AND GET RIGHT ATRIAL DISC INTO THE RIGHT ATRIUM USING VARIOUS GUIDEWIRES AND GUIDE CATHETERS, BUT INTRACARDIAC ECHOCARDIOGRAPHY SHOWED EACH TIME THE RIGHT ATRIAL DISC WOULD END UP IN THE LEFT ATRIUM. IT WAS DETERMINED THAT THE 25MM AMPLATZER PFO OCCLUDER WAS TOO SMALL. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 25MM AMPLATZER PFO OCCLUDER WITH A 35MM AMPLATZER PFO OCCLUDER. HOWEVER, IT WAS NOTED DURING DEPLOYMENT OF THE 35MM AMPLATZER PFO THAT A THROMBUS WAS PRESENT IN THE PATIENT'S RIGHT ATRIUM, BUT DID NOT ADHERED TO THE OCCLUDER OR THE DELIVERY SYSTEM. THE DECISION WAS MADE TO ABORT THE IMPLANT PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD BEEN ADMINISTERED HEPARIN, BUT THERE WAS NO ACTIVATED CLOTTING TIME TAKEN. BOTH THE 25MM AND 35MM AMPLATZER PFO OCCLUDER HAD BEEN REMOVED PRIOR TO RELEASE FROM THEIR

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15456619 ↗
• MalfunctionSep 6, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35 MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. UPON DEPLOYMENT OF THE DEVICE, THE RIGHT SIDED DISK BULGED AND DESPITE REPOSITIONING AND MANEUVERING OF THE DEVICE THE DISK WOULD NOT FLATTEN OUT AS SHOULD. THE DEVICE WAS RE-CAPTURED, REMOVED, AND A NEW 35MM PFO DEVICE DEPLOYED WITH A GOOD RESULT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362895 ↗
• MalfunctionAug 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. THE DEFECT WAS EVALUATED VIA ICE. THE USER EXPERIENCE DIFFICULTY INSERTING THE OCCLUDER INTO THE LOADER. ONCE IN THE LEFT ATRIUM, THE DEVICE DEPLOYED WITH AN UNSPECIFIED DEFORMATION. THE OCCLUDER WAS RE-SHEATHED AND DEPLOYED AGAIN, HOWEVER THE ISSUE PERSISTED. NO INTERACTIONS WITH CARDIAC STRUCTURES WERE REPORTED AND THERE WAS NO ANGULATION OR KINK OF THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE CABLE AND REMOVED FROM THE PATIENT. A NEW 30MM AMPLATZER PFO OCCLUDER WAS SELECTED AND SUCCESSFULLY IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298799 ↗
• MalfunctionAug 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE THE DEVICE DID NOT CORRECTLY DEPLOY; IT REMAINED OPENED LIKE A BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED. DURING INSPECTION, IT WAS OBSERVED THAT THE RIGHT DISC REMAINED OPENED AND HANDLING WAS REQUIRED TO CORRECT THE DEFORMATION. FURTHER INSPECTION REVEALED THAT AT THE ARM LINKING THE 2 DISCS, THE NITINOL THREAD APPEARED TO BE NOT CORRECTLY KNITTED. A NEW 35MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298568 ↗
• MalfunctionAug 4, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT 11 JULY 2022, A 35MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER AND A 9F AMPLATZER TORQVUE DELIVERY SYSTEM WERE SELECTED FOR PROCEDURE. IT WAS CONFIRMED VIA INTRAOPERATIVE ESOPHAGEAL ULTRASOUND, THAT THE AMPLATZER PFO OCCLUDER EXHIBITED A BULBOUS DEFORMATION WHEN DEPLOYING IT INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE 35MM AMPLATZER PFO OCCLUDER WITH AN UNKNOWN NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165482 ↗
• MalfunctionApr 11, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 35MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR PROCEDURE (B)(6) 2022 DURING THE PROCEDURE, THE USER ATTEMPTED TO POSITION THE DEVICE AND RE-SHEATHED THE DEVICE ONCE. THE DEVICE WAS THEN REDEPLOYED AND THE RIGHT DISC PRESENTED WITH A BULBOUS SHAPE. THE DEVICE WAS REMOVED AND A NEW 30MM PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075131 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). ADDITIONAL INFORMATION RECEIVED INDICATING THAT ON (B)(6) 2021, THE PATIENT DEVELOPED ATRIAL FIBRILLATION THAT REQUIRED CARDIOVERSION, APIXABAN, AND A HOLD IN PLAVIX. THE PATIENT WILL BE MONITORED ON THEIR FOLLOW-UPS.

  Patient problems: Atrial Fibrillation

  MAUDE report 13061266 ↗
• MalfunctionDec 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 35 MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR PROCEDURE OF A PFO CLOSURE AFTER THE PFO MEASUREMENTS WERE DETERMINED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE SCRUB TECH AND PHYSICIAN PREPARED THE PFO DEVICE ALONG WITH A 9 F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM. AFTER THE DEVICE CABLE WAS PULLED THROUGH TO BRING THE PFO DEVICE FROM THE SALINE BATH INTO THE LOADER, IT WAS NOTED THAT THERE WERE BUBBLES IN THE LOADER. THE DEVICE CABLE WAS PUSHED SO THAT THE PFO DEVICE CAME OUT OF THE LOADER AND BACK INTO THE SALINE BATH IN ATTEMPT TO REMOVE ALL THE BUBBLES FROM THE DELIVERY SYSTEM. THE DEVICE WAS PULLED OUT INTO THE SALINE BATH AND BACK INTO THE LOADER 3 TIMES IN ORDER FOR NO AIR BUBBLES TO BE SEEN. ONCE THE DEVICES WERE PREPARED, THE LOADER WAS ATTACHED TO THE DELIVERY SHEATH AND THE PFO DEVICE WAS ADVANCED INTO THE PATIENT'S BODY. THE PFO DEVICE WAS DEPLOYED, AND THE RIGHT ATRIAL DISC DID NOT LAY FLAT AS INTENDED. ATTEMPTS WERE MADE TO PUSH THE CABLE AND DELIVERY SHEATH TO TRY TO FLATTEN THE DISC WITHOUT SUCCESS. THE RIGHT ATRIAL DISC WAS RETRIEVED AND REDEPLOYED, BUT THE RIGHT ATRIAL DISC REMAINED EXPANDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968845 ↗