Amplatzer™ PFO Occluder (REF 9-PFO-025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00811806011288), received between Jun 11, 2018 and Sep 17, 2026 — classified as 1 death, 99 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (35 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 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809479 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE THE OCCLUDER TOOK ON A BULBOUS SHAPE AT THE WAIST OF THE DEVICE. THERE WAS SOME INTERACTION WITH CARDIAC STRUCTURES. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25MM AMPLATZER PFO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619380 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_806 - PFO OCCLUDER PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A UNKNOWN SIZE AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, A 5000 UNITS OF HEPARIN WAS GIVEN AND THE OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH LEFT ARM WEAKNESS AND LEFT ARM WENT LIMP. THE PATIENT ALSO HAD A BLOODY NOSE AND IT GOT RESOLVED. THE SYMPTOMS LASTED LESS THAN ONE MINUTE AND GOT RESOLVED. SOME MEDICATIONS WERE ADMINISTERED. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: Movement Disorder

  MAUDE report 23441571 ↗
• MalfunctionOct 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE OCCLUDER RELEASED FORM WAS NOT IN A GOOD CONDITION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378883 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER (LOT: 6551982) WAS IMPLANTED. SINCE APPROXIMATELY FOUR WEEKS POST-OPERATION, THE PATIENT EXPERIENCED FULL BODY HIVES WHENEVER EXERTING ANY KIND OF ENERGY AND DOES NOT SWEAT ANYMORE. IN ADDITION, THE PATIENT FEELS INFLAMED ALL THE TIME WITH PUFFY EYES. AN ALLERGIC REACTION TO THE AMPLATZER PFO OCCLUDER IS SUSPECTED BY THE PATIENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21873837 ↗
• MalfunctionMar 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE "REBOUND OF THE PATIENT FORAMEN OVALE OCCLUDER IS POOR AND CANNOT BE CONTINUED TO BE USED." "THE COMPRESSION OF THE OCCLUDER WAS NOT RESTORED TO ITS ORIGINAL STATE" AND HAD A BULBOUS-LIKE DEFORMATION. THERE WERE NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. A NEW 35MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635124 ↗
• MalfunctionFeb 3, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER PFO WAS SELECTED FOR IMPLANT. DURING DEVICE PREP, A THREAD WAS FOUND ON THE EDGE OF THE SURFACE OF THE OCCLUDER. A 18MM AMPLATZER PFO WAS USED INSTEAD AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294491 ↗
• MalfunctionDec 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF THE DEVICE TOOK ON A BULBOUS SHAPE. SEVERAL ATTEMPTS WERE MADE TO RE-LOAD THE DEVICE AND RE-DEPLOY, HOWEVER THE DISCS MAINTAINED A DEFORMED SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25MM AMPLATZER PFO OCCLUDER. THERE WERE SOME INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS DURING THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926318 ↗
• InjuryAug 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED. IN (B)(6) 2023, A PATIENT FOLLOW-UP SHOWED THAT THERE WAS RESIDUAL SHUNT PRESENT. IN (B)(6) 2023, THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE AND PATCH THE PFO. THE PATIENT IS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991941 ↗
• InjuryAug 9, 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) 2022, 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, A 6000 UNITS OF HEPARIN WAS ADMINISTERED AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE, A IMPLANTABLE LOOP RECORDER WAS CONNECTED TO THE PATIENT. THE LOOP RECORDER SHOWED 3 SEPARATE EPISODES OF 3 MINUTE ATRIAL FIBRILLATION. THE PATIENT STOPPED TAKING ASPIRIN AND STARTED 20MG RIVAROXABAN. THEY PLANNED TO REASSESS THE LOOP RECORDER AGAIN IN 6 MONTHS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Atrial Fibrillation

  MAUDE report 19949600 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS IMPLANTED ON (B)(6) 2021. AFTER THE OCCLUDER IMPLANT, ASPIRIN AND DIRECT ORAL ANTICOAGULANTS (DOACS) WERE BEING PRESCRIBED UNTIL ONE-YEAR POSTOPERATIVE FOLLOW UP. AFTER ONE-YEAR FOLLOW UP, DO DIRECT ORAL ANTICOAGULANTS (DOACS) WAS DISCONTINUED AND ONLY ASPIRIN WAS BEING TAKEN. ATRIAL FIBRILLATION WAS DETECTED ON (B)(6) 2024. THREE YEARS AFTER PROCEDURE. DIRECT ORAL ANTICOAGULANTS (DOACS) WERE ADMINISTERED FOR ANTICOAGULATION. NO OTHER INTERVENTION HAS BEEN PLANNED. THE PATIENT HAS KEPT BEING TAKEN WAIT AND SEE APPROACH.

  Patient problems: Atrial Fibrillation

  MAUDE report 19917242 ↗
• MalfunctionJun 25, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THEY PULLED OUT THE RIGHT DISK IN THE RIGHT ATRIUM OF THE HEART, THE OCCLUDER TOOK A DONUT SHAPE. THE OPERATOR WITHDRAWN THE OCCLUDER FROM THE SHEATH, RINSED IT AND TRIED TO IMPLANT IT AGAIN, BUT THE OCCLUDER TOOK THE SHAPE OF A DONUT AGAIN. 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. A NEW 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN. 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 19607685 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_961 - PFO JAPAN PAS, PATIENT SITE ID: (B)(6) (R845396001). IT WAS REPORTED THAT ON (B)(6) 2021, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT WAS PRESCRIBED P2Y12 INHIBITOR AND DUAL ORAL ANTICOAGULATION MEDICATION AFTER PROCEDURE. ON 30 AUGUST 2023, IT WAS NOTED THAT THE PATIENT SUFFERED A HEMORRHAGIC STROKE. THE PATIENT'S SYMPTOMS LASTED LESS THAN 24 HOURS. THERE WAS NO TREATMENT REQUIRED. HOWEVER, THE PATIENT WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2023. IT WAS NOTED DURING THE PATIENT'S 3 YEAR FOLLOW UP THAT THERE WAS NO SIGNIFICANT RESIDUAL SHUNT OR THROMBUS SEEN ATTACHED TO THE DISC OF THE 25MM AMPLATZER (PFO) OCCLUDER. THE OCCLUDER REMAINS IMPLANTED AND NO ANOMALY OF THE OCCLUDER HAS BEEN REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 19570608 ↗
• InjuryJun 4, 2024Adverse 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 PFO WAS IMPLANTED IN A PATIENT. DUAL ANTIPLATELET AGENTS (ASPIRIN/ P2Y12 INHIBITORS) WERE PRESCRIBED AFTER THE PROCEDURE. 2Y12 INHIBITORS WAS DISCONTINUED AFTER A 30-DAY POSTOPERATIVE FOLLOW UP. THE PATIENT TOOK ONLY ASPIRIN AGENT SINCE A 30-DAY POSTOPERATIVE FOLLOW UP. ON OCT 15, 2021, ATRIAL FIBRILLATION WAS DETECTED WITH AN IMPLANTABLE MONITOR. THE PATIENT WAS STARTED ON APIXABAN ON DEC 28, 2021. REPORTEDLY, ATRIAL FIBRILLATION HAS BEEN STILL SEEN AT THE MOMENT. THE PATIENT IS STABLE.

  Patient problems: Atrial Fibrillation

  MAUDE report 19463935 ↗
• MalfunctionMay 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 29 APRIL 2024, A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT, THE FIRST DISC WAS DEPLOYED WITHOUT ISSUE. HOWEVER, DURING DEPLOYMENT OF THE SECOND DISC, DISC BULGING WAS OBSERVED. LIGHT TUGGING WAS PERFORMED, BUT THE DEFORMATION PERSISTED AND THE DEVICE WAS RETRIEVED AND REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION OR KINK NOTICED WITH THE DELIVERY SYSTEM AND NO REPORT OF INTERACTION WITH ANY CARDIAC STRUCTURES DURING DEPLOYMENT. A NEW 25MM 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 19363040 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_961 - PFO JAPAN PAS, PATIENT SITE ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2021, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED WITH A PRESCRIPTION FOR ASPIRIN AND P2Y12 INHIBITORS. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH AN ARRHYTHMIA. AN ELECTROCARDIOGRAM AT AN OUTPATIENT CLINIC HAD SHOWED THAT THE PATIENT WAS IN SINUS RHYTHM. THEREFORE, A HOLTER ELECTROCARDIOGRAM WAS PERFORMED ON (B)(6) 2024, AND CONFIRMED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION. ON (B)(6) 2021, THE PATIENT WAS STARTED ON DIRECT ORAL ANTICOAGULANTS TO PREVENT FURTHER SYMPTOMS DUE TO ATRIAL FIBRILLATION. THE CAUSE OF THE PATIENT'S ATRIAL FIBRILLATION WAS UNABLE TO BE DETERMINED.

  Patient problems: Arrhythmia; Atrial Fibrillation

  MAUDE report 19226255 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_961 - PFO JAPAN PAS, PATIENT SITE ID:(B)(6). IT WAS REPORTED THAT A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED ON (B)(6) 2021. P2Y12 INHIBITOR (ANTIPLATELET) AND DIRECT ORAL ANTICOAGULANTS (DOAC) WERE PRESCRIBED POST-PROCEDURE. ON (B)(6) 2023, DURING A 2-YEAR PATIENT FOLLOW-UP NO ISSUES WERE DETECTED AND THE PATIENT WAS ONLY PRESCRIBED ANTIPLATELET. ON (B)(6) 2023 THE PATIENT EXPERIENCED AN ISCHEMIC STROKE AND PRESENTED WITH PARALYSIS IN THE UPPER AND LOWER EXTREMITIES AND APHASIA. THE PATIENT WAS RUSHED TO THE HOSPITAL AND ADMINISTERED EDARAVONE. THE SYMPTOMS WERE REPORTEDLY RESOLVED. IT WAS BELIEVED THAT THE STROKE WAS UNRELATED TO THE DEVICE AND PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Movement Disorder; Stroke/CVA

  MAUDE report 19203843 ↗
• InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, "RECURRENT DECOMPRESSION ILLNESS EVEN AFTER THE CLOSURE OF PATENT FORAMEN OVALE IN A DIVER", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 41-YEAR-OLD MALE PATIENT WITH PRIOR EPISODES OF DECOMPRESSION ILLNESS (DCI), PRIOR HYPERBARIC OXYGEN THERAPY, SMOKING HISTORY, DYSLIPIDEMIA, AND A PATENT FORAMEN OVALE (PFO). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 25MM AMPLATZER PFO WAS IMPLANTED. IT WAS THEN REPORTED SIX MONTHS POST-PROCEDURE, DURING A FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) EXAMINATION USING SALINE BUBBLES SHOWED THE PFO WAS WELL SEATED IN THE INTERATRIAL SEPTUM WITHOUT A PERIDEVICE THROMBUS. HOWEVER, IT WAS ALSO NOTED THAT >20 SALINE BUBBLES STILL CROSSED THE REMNANT PFO CHANNEL DURING THE VALSALVA MANEUVER. THE PATIENT WAS ADVISED TO REFRAIN FROM DIVING BUT WAS NON-COMPLIANT. ON AN UNKNOWN DATE 8 MONTHS POST PFO CLOSURE, THE PATIENT EXPERIENCED HEADACHE, PAINFUL SENSATION IN THE HANDS AND FEET, AND SKIN RASH AND PRURITUS IN BOTH FEET DUE TO RECURRENT DECOMPRESSION ILLNESS. THE PATIENT UNDERWENT HYPERBARIC OXYGEN CHAMBER THERAPY. THE ARTICLE CONCLUDED THAT THIS CASE INDICATES THAT THE RISK OF DCI MAY REMAIN EVEN AFTER PFO CLOSURE. THE INCOMPL

  Patient problems: Headache; Pain; Rash

  MAUDE report 18889662 ↗
• MalfunctionFeb 20, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS PREPARED PER IFU. DURING IMPLANT THE RIGHT ATRIAL DISC OF THE DEVICE TOOK ON A PUFFED UP SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25-18MM AMPLATZER TALISMAN PFO OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739949 ↗
• MalfunctionJan 10, 2024Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6)2023, A A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT WAS SLATED FOR ATRIAL SEPTAL DEFECT (ASD) CLOSURE. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. 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 PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN DECIDED TO CHANGE THE DEVICE BECAUSE IT WAS UNSAFE TO USED. A NEW 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486745 ↗
• InjuryJan 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT IN AN UNKNOWN DATE IN 2021, A 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA) WITHIN THE LAST 2 YEARS. A REPEAT TRANS-OESOPHAGEAL ECHOCARDIOGRAM (TOE) BUBBLE STUDY SHOWED BUBBLES MOVING ACROSS THE DEFECT. ON (B)(6) 2023, THE PATIENT WAS BROUGHT BACK TO IMPLANT ANOTHER PFO OCCLUDER. A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS ATTEMPTED. HOWEVER, BEFORE RELEASE, BUBBLE STUDY WAS DONE, SHOWING BUBBLES STILL MOVING ACROSS THE LEFT ATRIUM. THE DEVICE WAS REMOVED, AND A REPLACEMENT 30MM NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE DISCHARGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Transient Ischemic Attack

  MAUDE report 18466715 ↗
• InjuryDec 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, "A VERY RARE AND UNUSUAL COMPLICATION AFTER A PERCUTANEOUS PATENT FORAMEN OVALE CLOSURE" WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 47-YEAR-OLD FEMALE WHO PRESENTED WITH AN ATRIAL SEPTAL ANEURYSM AND PATENT FORAMEN OVALE (PFO). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED TO OCCLUDE A PFO WITHOUT ISSUE AND REASSURING TUG TEST. SIX WEEKS POST PROCEDURE, THE PATIENT PRESENTED WITH PALPITATIONS AND SUBSEQUENT IMAGING REVEALED THE DEVICE HAD EMBOLIZED INTO THE DESCENDING AORTA. A DECISION WAS MADE TO EXPLANT THE DEVICE VIA TRANSCATHETER SNARE. THE ARTICLE CONCLUDED THAT THIS CASE DEMONSTRATED THAT PERCUTANEOUS RETRIEVAL OF AN EMBOLIZED PFO OCCLUDER, ALTHOUGH CHALLENGING, IS FEASIBLE AND MIGHT BE A VIABLE ALTERNATIVE TO A RISKIER CONVENTIONAL SURGICAL APPROACH, WITH THE DOUBLE SNARE TECHNIQUE AND LARGE SHEATH USAGE POTENTIALLY IMPROVING SUCCESS RATES AND REDUCING RE-EMBOLIZATION RISKS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS CLAUDIU UNGUREANU, CARDIOVASCULAR JOLIMONT HOSPITAL, RUE FERRER, 159, 7100 LA LOUVIÈRE, BELGIUM; AND 2CARDIOVASCULAR DEPARTMENT, CLINIQUE SAINT JOSEPH, VIVALIA, ARLON, BELGIUM, WITH CORRESPONDING EMAI

  Patient problems: Arrhythmia

  MAUDE report 18369649 ↗
• MalfunctionDec 19, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF THE DEVICE DEVELOPED POORLY AND WAS OBSERVED TO BE DILATED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25MM AMPLATZER PFO OCCLUDER, WHICH WAS IMPLANTED SUCCESSFULLY. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES NOR WERE THERE ANY ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT WAS NOTED TO BE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360619 ↗
• MalfunctionNov 15, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE RIGHT ATRIAL DISC TOOK ON A BOWL SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND PREPARED IN A BOWL, IN WHICH THE RIGHT ATRIAL DISC TOOK ON A BOWL SHAPE AGAIN. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WERE NO ANGULATION OR KINKS NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145604 ↗
• InjuryAug 8, 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 25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER (LOT: 8902531) WAS IMPLANTED INTO A PFO UTILIZING A 8F TREVISIO DELIVERY SYSTEM (LOT: 8873827). SIZING WAS DETERMINED VIA ANATOMICAL FEATURES BUT EXACT MEASUREMENTS WERE NOT COMPLETED. AFTER DEPLOYMENT THE DEVICE THEN DISLODGED AND EMBOLIZED. THE DEVICE WAS SNARED AND REMOVED FROM THE PATIENT. THE RETRIEVAL WAS CONSIDERED AN EMERGENCY PROCEDURE. A REPLACEMENT 35MM AMPLATZER PFO OCCLUDER (LOT: 7952852) WAS THEN IMPLANTED SUCCESSFULLY WITH A 9F TREVISIO DELIVERY SYSTEM (LOT: 8807488). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481473 ↗