Amplatzer™ Talisman™ 9-PFO-3525Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05415067033345), received between Sep 9, 2022 and Sep 22, 2026 — classified as 1 death, 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 22, 2026Difficult to Fold, Unfold or Collapse; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859392 ↗
• InjuryMar 3, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F DELIVERY SYSTEM IN A 61-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF STROKE AND PRIOR SURGICAL AORTIC VALVE REPLACEMENT, WHO PRESENTED TO THE CATHETERIZATION LAB FOR PFO CLOSURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO UTILIZE INTRACARDIAC ECHOCARDIOGRAPHY (ICE); HOWEVER, IMAGING WAS LIMITED DUE TO CHALLENGING ACOUSTIC WINDOWS, AS THE PATIENT¿S HEART WAS NOTED TO BE POSITIONED MORE HORIZONTALLY. AS A RESULT, THE PHYSICIAN RELIED PRIMARILY ON FLUOROSCOPY FOR DEVICE POSITIONING, WITH ONLY LIMITED GUIDANCE FROM ICE. IN THIS CASE, GIVEN PRIOR AORTIC VALVE SURGERY AND THE RESULTING CARDIAC ROTATION THAT LIMITED ICE, THE PHYSICIAN DECIDED TO SIZE BASED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). AN INITIAL 25-18 MM AMPLATZER TALISMAN OCCLUDER WAS SELECTED. WITH ONLY THE LEFT DISC DEPLOYED, A GENTLE TUG WAS PERFORMED TO CONFIRM ENGAGEMENT AGAINST THE SEPTUM; THE DEVICE PULLED THROUGH, PROMPTING THE DECISION TO UPSIZE. 35¿25 MM AMPLATZER TALISMAN OCCLUDER WAS SUBSEQUENTLY IMPLANTED VIA A 9F DELIVERY SYSTEM. A RIGOROUS PUSH¿PULL STABILITY TEST WAS PERFORMED, WITH NO INDICAT

  Patient problems: Arrhythmia

  MAUDE report 24503141 ↗
• MalfunctionDec 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM FOR A PFO CLOSURE IN A PATIENT WITH RECENT STROKE. TRANSOESOPHAGEAL ECHOCARDIOGRAPHY (TOE) REVEALED AN ANEURYSMAL SEPTUM, A LONG TUNNEL PFO, AND A TRIANGULATED FENESTRATED WEB CONNECTING THE PFO TUNNEL TO THE LEFT SIDE OF THE HEART. THE 30-25 MM AMPLATZER TALISMAN PFO OCCLUDER WAS DEPLOYED BUT DID NOT SIT FLAT; THE LEFT ATRIAL (LA) DISC DID NOT REACH THE TUNNEL, AND THE RIGHT ATRIAL (RA) DISC AT THE AORTIC END POSED A RISK OF ENTERING THE TUNNEL AND CAUSING EMBOLIZATION. THE DEVICE WAS UPSIZED TO A 35-25 MM AMPLATZER TALISMAN PFO OCCLUDER; HOWEVER, THE DEVICE AGAIN DID NOT SIT FLAT, AND SIGNIFICANT BUBBLES WERE OBSERVED PASSING THROUGH AND AROUND THE DEVICE ON BUBBLE STUDY POST-DEPLOYMENT. THE TRANSSEPTAL PUNCTURE WAS MADE ANTERIOR TO THE AORTIC VALVE. THE 35-25 MM DEVICE WAS REPREPPED, BUT DIFFICULTY WAS ENCOUNTERED WHILE LOADING IT BACK INTO THE LOADER AFTER FLUSHING. WHEN ADVANCED OUT OF THE LOADER ON THE TABLE, THE RA DISC APPEARED BULBOUS. THE PROCEDURE WAS COMPLETED USING A NEW 35-25 MM AMPLATZER TALISMAN PFO OCCLUDER. THE PATIENT REMAINED HEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872890 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709238 ↗
• MalfunctionOct 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373373 ↗
• MalfunctionOct 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352793 ↗
• MalfunctionApr 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. DURING PROCEDURE, AN ATTEMPT WAS MADE TO PLACE THE DEVICE BUT THE ENTIRE DISK CONTINUED TO DEVIATE TO THE RIGHT ATRIAL SIDE DURING RIGHT ATRIAL DEPLOYMENT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WAS THEN CHANGED TO A NEW 35-25MM AMPLATZER TALISMAN PFO OCCLUDER, BUT THE SAME SITUATION PERSISTED, LEADING TO THE TERMINATION OF THE PROCEDURE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT. 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 AND NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21798454 ↗
• MalfunctionJan 31, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 35-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. IT WAS NOTED DURING PROCEDURE THAT THE RIGHT ATRIAL DISC OF THE OCCLUDER EXHIBITED A MUSHROOM SHAPED DEFORMATION WHEN BEING DEPLOYED. AN ATTEMPT AT PRESSING THE SHEATH WAS AGAINST THE OCCLUDER DID NOT IMPROVE THE SITUATION. THERE WAS NO CONTACT WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THERE WERE NO BENDS OR KINKS OBSERVED IN THE DELIVERY SHEATH. THE DECISION WAS MADE TO RECAPTURE AND REMOVE THE OCCLUDER PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE 35-25MM AMPLATZER TALISMAN (PFO) OCCLUDER WAS REPLACED WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282810 ↗
• MalfunctionNov 15, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. DURING IMPLANT THE DEVICE TOOK ON A BULBOUS SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 35-25MM AMPLATZER TALISMAN PFO OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON 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 UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696157 ↗
• MalfunctionOct 3, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH TO CLOSE A PATENT FORAMEN OVALE (PFO). DURING DEVICE PREPARATION IT WAS NOTED THAT THE DEVICE APPEARED TO HAVE NO WAIST AND LOOKED TO BE SHAPED AS ONE BUBBLE. THE DECISION WAS MADE TO REPLACE THE DEVICE. NO OTHER 30-25MM SIZED OCCLUDER WAS AVAILABLE SO A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED AS A REPLACEMENT. DURING IMPLANT IT WAS NOTED THAT THE SKIRT OF THE DEVICE WAS TOO CLOSE IN PROXIMITY TO THE AORTA AND THE DEVICE TOOK ON A BUBBLE SHAPE. THE OCCLUDER AND DELIVERY SHEATH WERE BOTH REMOVED FROM THE PATIENT AND REPLACED WITH A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM AND 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359615 ↗
• MalfunctionApr 11, 2024Difficult to Fold, Unfold or Collapse; Separation Problem; Difficult to Fold, Unfold or Collapse; Separation Problem

  IT WAS REPORTED THAT ON 22 MARCH 2024, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE DEVICE COULD NOT BE DEPLOYED FROM THE CABLE. IT IS UNKNOWN IF A DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089720 ↗
• InjuryMar 15, 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 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV). THE DEVICE WAS IMPLANTED. APPROXIMATELY 5-10 MINUTES AFTER THE PROCEDURE, THE PATIENT WENT TO BRADYCARDIA AND ATROPINE WAS GIVEN. THE PATIENT HAD A PACEMAKER IMPLANTED PRIOR TO LEAVING FROM CATHETERIZATION LABORATORY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Bradycardia

  MAUDE report 18918793 ↗
• DeathFeb 27, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON 02 FEBRUARY 2024, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. DURING PROCEDURE, THE PATIENT WAS UNDER DEEP SEDATION, THE PHYSICIAN ADVANCED THE DILATOR AND DELIVERY SHEATH OVER THE GUIDEWIRE THROUGH THE PFO AND INTO THE LEFT ATRIUM AND REMOVED THE DILATOR AND THE GUIDEWIRE BEFORE CONNECTING THE LOADER, DURING BACKFLOW, TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TOE) REVEALED BUBBLES IN THE LEFT ATRIUM. THE PHYSICIAN MENTIONED AN HYPOTHESIS OF PRESSURE INVERSION WHICH LED TO AIR EMBOLISM FROM THE DELIVERY SYSTEM. THE PHYSICIAN ATTACHED THE LOADER TO THE DELIVERY SHEATH (IN A WET-TO-WET CONDITION) AND POSITIONED THE DEVICE, PATIENT HAD CARDIAC ARREST. THE PHYSICIAN MADE SEVERAL MANEUVERS TO RECOVER THE PATIENT, AND THE DEVICE WAS NOT RELEASED AND GOT RECAPTURED. THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS IRREVERSIBLE CARDIAC ARREST.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 18790019 ↗
• MalfunctionJan 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON 4 JANUARY 2024, A 35-25MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. PREPARATION WAS DONE PER IFU, THE OCCLUDER WAS UNLOCKED, TAKEN TO LOCK AND RELEASED 1/8 TURN. ONCE IMPLANTED AND PHYSICIAN SATISFIED WITH THE POSITION, THE CABLE WAS TURNED COUNTER-CLOCKWISE AND RELEASED AFTER ONLY ONE TURN. THE DEVICE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592083 ↗
• MalfunctionDec 29, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35-25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT ON 06 (B)(6) 2023 USING 9F AMPLATZER TALISMAN DELIVERY SHEATH. DURING DEVICE PREPARATION, IT WAS NOTED THAT THE RIGHT DISC OF THE DEVICE TOOK ON A DEFORMED SHAPE. THE OPERATOR ATTEMPTED TO RESHAPE THE DEVICE AND CHOSE TO IMPLANT IT. DURING IMPLANT THE RIGHT DISC MAINTAINED A SPHERICAL SHAPE IN THE RIGHT ATRIUM. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 30-25MM AMPLATZER PFO OCCLUDER. THERE WERE NO KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416893 ↗
• MalfunctionDec 21, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM TO TREAT A LARGE ATRIAL SEPTAL DEFECT ASSOCIATED TO A PATENT FORAMEN OVALE. DURING IMPLANT THE DEVICE TOOK ON A ROUND SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 40MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES NOR WERE THERE ANY ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. DURING DEVICE PREPARATION, THE DEVICE TOOK ON A ROUND SHAPE. THE DEVICE WAS REPLACED WITH A NEW 40MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM, WHICH WAS SUCCESSFULLY IMPLANTED USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. 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 STATUS WAS NOTED AS FINE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372469 ↗
• InjurySep 15, 2023Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  THE ARTICLE, "FOURTH TIME¿S A CHARM: COMPLEX CLOSURE OF INCOMPLETE LEFT ATRIAL APPENDAGE EXCLUSION", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 69-YEAR-OLD MAN WITH A HISTORY OF ATRIAL FIBRILLATION (AF) PRESENTED FOR THE MANAGEMENT OF RECURRENT ISCHEMIC STROKES. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR PROCEDURE WITH A 12F NON-ABBOTT DEFLECTABLE SHEATH TO OCCLUDE A PERI-DEVICE LEAK OF A PREVIOUSLY IMPLANTED 27MM NON-ABBOTT DEVICE. IT WAS THEN NOTICED VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) THERE WAS A RESIDUAL SHUNT OF THE DEVICE DUE TO NON-APPROXIMATION OF THE PROXIMAL DISC. A DECISION WAS MADE TO IMPLANT A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER AND THE PATIENT'S LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RODNEY HORTON, TEXAS CARDIAC ARRHYTHMIA INSTITUTE, ST. DAVID¿S MEDICAL CENTER, 3000 N. IH-35, SUITE 720,AUSTIN, TEXAS 78705, USA, WITH CORRESPONDING E-MAIL: [email protected]].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755916 ↗
• InjuryJun 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN TO IMPLANT IN A 10MM PATENT FORAMEN OVALE (PFO) DEFECT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, A RESIDUAL LEAK WAS SHOWED IN TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND BALLOON. THE DEVICE WAS NOT REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE PHYSICIAN REMOVED THE DEVICE WITH SNARE. THE PHYSICIAN CONFIRMED THERE WAS NO ADDITIONAL PRODUCT EXPERIENCE OTHER THAN THE MIS-SIZING. AFTER THAT, THEY TRIED 3 UNKNOWN SIZE NON ABBOTT DEVICES BUT IT DOESN'T WORK WELL. A NEW 48MM SIZE GORE DEVICE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146437 ↗
• InjuryMay 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT. PRIOR TO IMPLANT, IT WAS NOTED THAT THE PATIENT HAD A MOBILE SEPTUM. THE SIZING BALLOON THAT WAS USED WAS 12-14MM IN DIAMETER. AFTER THE DEVICE WAS PLACED, THE RIGHT ATRIAL DISK APPEARED TO BE TOUCHING THE AORTA VERTICALLY, AND THE DISK TOUCHED THE POSTERIOR WALL OF THE RIGHT ATRIUM. HOWEVER, THE DISK WAS NOT PUSHING ON THE AORTA OR ATRIUM AND THE PROCEDURE WAS CONCLUDED. AFTER THE PROCEDURE, THE PATIENT WAS ON DUAL ANTI-PLATELET THERAPY (DAPT) REGIMEN FOR ONE MONTH, THEN SINGLE ANTI-PLATELET THERAPY (SAPT) WAS PRESCRIBED GOING FORWARD. DURING FOLLOW-UP ECHOCARDIOGRAMS PERFORMED AT 1, 3, AND 6 MONTHS, NO DEVICE PROBLEMS WERE OBSERVED AND THERE WAS NO PERICARDIAL EFFUSION SEEN. ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL DUE WITH CHEST PAIN. IT WAS CONFIRMED THAT THE PATIENT HAD CARDIAC TAMPONADE, AND PERICARDIAL DRAINAGE WAS PERFORMED. ON (B)(6) 2023, PERFORATION WAS SEEN ON THE CEILING OF THE LEFT ATRIUM AND A THORACOTOMY WAS PERFORMED. THE LEFT ATRIAL DISC MARGIN WAS PARTIALLY VISIBLE NEXT TO THE LEFT ATRIUM, AND IT WAS CONFIRMED THAT THE DISC WAS PARTIALLY PROTRUDING

  Patient problems: Angina; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 16940239 ↗
• InjuryMar 21, 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) 2022, A 30MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. PRIOR TO RELEASE, IT WAS UNCLEAR IF THERE WAS SEPTUM TISSUE IN BETWEEN THE DEVICE DISCS. A TUG TEST WAS PERFORMED BY THE IMPLANTING FELLOW AND NO PROBLEMS WERE NOTED. AFTER THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE IT EMBOLIZED TO THE LEFT ATRIUM (LA). THERE WAS NO OBSTRUCTION CAUSED BY THE DEVICE AFTER IT EMBOLIZED. THE DEVICE WAS ATTEMPTED TO SNARE BUT THIS WAS NOT SUCCESSFUL. AT THIS POINT, THE DEVICE WAS ATTEMPTED TO RETRACT BACK INTO THE 9F DELIVERY SYSTEM. PARTIAL RETRACTION OF THE DEVICE INTO THE DELIVERY SYSTEM OCCURRED THEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE PATIENT REMAINED IN SINUS RHYTHM THE ENTIRE PROCEDURE AND DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS. THE PROCEDURE WAS ABORTED, AND IT WAS PLANNED TO IMPLANT AN UNKNOWN DEVICE FOR PFO CLOSURE ON A LATER DATE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584705 ↗
• MalfunctionFeb 6, 2023Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING DEVICE PREPARATION THAT THERE HAD BEEN DIFFICULTY EXPERIENCED OBTAINING BLOOD BACKFLOW THROUGH THE LOADER. IT WAS ALSO NOTED DURING PROCEDURE THAT THE RIGHT ATRIAL DISC OF THE OCCLUDER EXHIBITED A BULBOUS DEFORMATION WHILE BEING DEPLOYED. THE DECISION WAS MADE TO REMOVE AND REPLACED THE 35-25MM AMPLATZER TALISMAN (PFO) OCCLUDER WITH A 30-25MM AMPLATZER TALISMAN (PFO) OCCLUDER TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308234 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 17 NOVEMBER 2022, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE OCCLUDER WAS CHOSEN TO CLOSE A LARGE PATENT FORAMEN OVALE (PFO) WITH BIDIRECTIONAL SHUNTING THAT WAS OBSERVED ON TRANSESOPHAGEOL ECHOCARDIOGRAM (TEE). PRIOR TO PROCEDURE FROM 30 OCTOBER 2022 TO 7 NOVEMBER 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SHORTNESS OF BREATH AND HYPOXIA DUE TO LARGE PFO. DURING PROCEDURE FOR IMPLANT OF PFO OCCLUDER, 8000 UNITS IV HEPARIN WERE ADMINISTERED, AND THE PATIENT WAS UNDER CONSCIOUS SEDATION. DURING DEPLOYMENT AND IMPLANTATION OF THE PFO OCCLUDER, THE PATIENT BECAME MINIMALLY RESPONSIVE AND HYPOXIC. THE SEDATION WAS REVERSED, AND OXYGEN SATURATION IMPROVED. HOWEVER, THE PATIENT WAS STILL MINIMALLY RESPONSIVE, SO THE PATIENT WAS INTUBATED. A CORONARY ANGIOGRAM WAS PERFORMED, WHICH WAS NEGATIVE FOR ACUTE OCCLUSIONS OF THE CORONARY ARTERIES. THE PATIENT WAS TRANSPORTED TO COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH THE STROKE NEUROLOGY TEAM. THE PATIENT WAS DIAGNOSED WITH ACUTE HYPOXIC RESPIRATORY FAILURE AND ALTERED LEVEL OF CONSCIOUSNESS WITH UNCLEAR ETIOLOGY. THE PATIENT STAT

  Patient problems: Hypoxia; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 15974581 ↗
• MalfunctionNov 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER (8213789) WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM (8157401). THE DEVICE WAS TESTED PRIOR TO PROCEDURE AND DEPLOYED NORMALLY, AS EXPECTED. WHEN ATTEMPTING TO DEPLOY THE PFO OCCLUDER, THE RIGHT ATRIAL DISK DEPLOYED IN A BULBOUS FORMATION. A KINK WAS NOTICED IN THE 9F DELIVERY SYSTEM (8157401) DURING THE FIRST DELIVERY OF THE DEVICE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE IN THE PATIENT. THE DEVICE WAS RETRIEVED AND REMOVED FROM THE PATIENT. THERE WAS NO NOTED INTERACTION WITH CARDIAC STRUCTURES. AN ATTEMPT WAS MADE TO RESTORE THE NORMAL SHAPE WHILE TESTING OUTSIDE OF THE PATIENT, BUT THE DEVICE DID NOT DEPLOY IN THE CORRECT FORMATION. THEREFORE, IT WAS REPLACED IT WITH A NEW 35-25MM AMPLATZER TALISMAN PFO OCCLUDER (8221783) AND IT DEPLOYED AS EXPECTED. THE REPLACEMENT OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A NEW 9F AMPLATZER TALISMAN DELIVERY SYSTEM (8277458). THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848496 ↗
• MalfunctionSep 9, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE USING A 9F TALISMAN DELIVERY SHEATH. IT WAS NOTED THAT DURING PROCEDURE THE RIGHT ATRIAL DISC OF THE OCCLUDER EXHIBITED A BULBOUS SHAPE WHEN BEING DEPLOYED. THE OCCLUDER WAS NEVER RELEASED FROM THE CABLE AND THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DECISION WAS MADE TO FULLY RECAPTURE AND REMOVE THE OCCLUDER FROM THE PATIENT AND ATTEMPT TO FIX THE OCCLUDER. AFTER AN UNSUCCESSFUL ATTEMPT TO FIX THE OCCLUDER, THE DECISION WAS MADE TO REPLACE THE 35-25MM AMPLATZER TALISMAN (PFO) OCCLUDER WITH AN UNKNOWN 25MM REPLACEMENT DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396124 ↗
• MalfunctionSep 9, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE IT WAS NOTED THAT THE AMPLATZER TALISMAN PFO OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THERE WERE THREE PARTIAL RECAPTURES AND DEPLOYMENTS PERFORMED, BUT THE DEFORMATION PERSISTED. THE OCCLUDER WAS NEVER RELEASED FROM THE CABLE AND THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT. NO ANGULATION/KINK OF THE DELIVERY SYSTEM WAS OBSERVED. THE DECISION WAS MADE TO FULLY RECAPTURE AND REMOVE THE OCCLUDER AND ATTEMPT TO FIX IT, BUT IT WAS NOTED THAT THE LEFT AND RIGHT ATRIAL DISC WERE MISALIGNED. THE DECISION WAS MADE TO REASSESS THE PATIENT'S ANNULUS AND AN UNKNOWN 25MM REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394038 ↗