Amplatzer™ 9-ASD-MF-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 00811806010298), received between Aug 27, 2018 and Aug 14, 2026 — classified as 1 death, 49 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (82 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 183 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Cribriform Occluder was chosen for implant. The defect characteristics were reported as a tunnel measuring 12 mm, an aortic rim >5 mm, and aneurysm excursion of approximately 1 mm. Device sizing was determined using transesophageal echocardiography (TEE), and TEE was also used as the imaging modality during the procedure. During post-procedure follow-up on (b)(6) 2026, the implanted device was found to be malpositioned. The migration/malposition was identified at follow-up by transthoracic echocardiogram. No clinical signs or symptoms were reported during or after the event. As a result, percutaneous withdrawal of the device was performed successfully. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261321 ↗
• MalfunctionAug 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209066 ↗
• MalfunctionJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS INTRODUCED AND ADVANCED FOR PLACEMENT, AND AFTER DEPLOYMENT, AN INCREASE IN THE PATIENT¿S LEFT ATRIAL (LA) PRESSURE WAS OBSERVED, WHICH WAS SUSTAINED. THE PATIENT DID NOT DEVELOP ANY CLINICAL SYMPTOMS, AND NO CLINICAL DIAGNOSIS WAS MADE IN RELATION TO THE PRESSURE INCREASE. THE DEVICE WAS NOT COMPLETELY RELEASED AND WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THEREFORE, THE PHYSICIAN CHOSE TO STOP THE PROCEDURE FOR SAFETY REASONS, AND NO OTHER DEVICE WAS ATTEMPTED. NO INTERVENTION OR TREATMENT WAS REQUIRED. THE INCREASE IN LA PRESSURE WAS DESCRIBED AS A CLINICALLY RECOGNIZED PHENOMENON THAT MAY OCCUR AFTER DEVICE PLACEMENT DUE TO OCCLUSION OF THE SHUNT, WHICH CAN INCREASE LOAD ON THE LEFT ATRIUM AND RIGHT HEART, AND CANNOT BE DETERMINED IN ADVANCE. NO ALLEGATIONS WERE MADE AGAINST ANY ABBOTT DEVICE, AND THE EVENT WAS NOT ATTRIBUTED TO DEVICE PERFORMANCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; High Blood Pressure/ Hypertension

  MAUDE report 25679611 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE SHUNT OCCLUSION PROCEDURE, THE CHOSEN 25 MM AMPLATZER CRIBRIFORM WAS ADVANCED FOR IMPLANTATION; HOWEVER, THE DEVICE WAS OBSERVED TO HAVE AN BULBOUS SHAPE ONCE DEPLOYED. IT WAS SUBSEQUENTLY REMOVED AND PLACED IN WARM SALINE IN AN ATTEMPT TO RESTORE ITS FORM, BUT THE IRREGULARITY PERSISTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN COMPLETED USING A 30¿25 MM AMPLATZER TALISMAN PFO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY 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 24719860 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHEN THE DEVICE WAS BEING DEPLOYED, THE LEFT DISC WAS OBSERVED TO FORM A CUP-LIKE SHAPE. MULTIPLE DEPLOYMENT ATTEMPTS WERE MADE; HOWEVER, THE LEFT DISC CONSISTENTLY RETAINED THE SAME ABNORMAL SHAPE. THE DEVICE WAS THEN REMOVED, AND WHEN IT WAS FULLY DEPLOYED OUTSIDE THE PATIENT, THE LEFT DISC CONTINUED TO APPEAR CUP-SHAPED. THE PROCEDURE WAS COMPLETED USING A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY 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 24719229 ↗
• MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS ASSEMBLED AND INSERTED INTO THE LOADER ACCORDING TO THE STEPS PROCEDURE AS USUAL. UPON RELEASE, BOTH DISCS OPENED ABNORMALLY, ALMOST FORMING AN HOURGLASS SHAPE. THE DEVICE WAS DEFORMED FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 25-18MM AMPLATZER PFO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY 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 24550859 ↗
• InjuryFeb 10, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS IMPLANTED USING AN ABBOTT DELIVERY SYSTEM. THE DEFECT MEASURED 9.86 MM, AND THE TOTAL SEPTAL LENGTH FROM RIM TO RIM WAS 26 MM. DEVICE SIZING WAS DETERMINED BY MEASURING THE TUNNEL LENGTH, THE MAXIMUM ELEVATION OF THE SEPTUM, AND THE LENGTH FROM THE POINT WHERE THE GUIDE PASSED TO THE END OF THE DEFECT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED AS THE IMAGING MODALITY DURING THE PROCEDURE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, WITH NO RHYTHM CHANGES OBSERVED. ON THE FOLLOWING MORNING, A TEE EXAMINATION INDICATED THAT THE DEVICE HAD BECOME DISPLACED; HOWEVER, IT WAS NOTED THAT THE DEVICE HAD NOT COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE IMPLANTER REPORTED UNCERTAINTY REGARDING THE CAUSE OF THE MIGRATION, CONSIDERING THAT THE SIZING HAD BEEN BELIEVED TO BE CORRECT. THE PATIENT EXPERIENCED NO CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THE EVENT. DEVICE DISPLACEMENT WAS IDENTIFIED DURING THE DISCHARGE-DAY TEE. A DECISION WAS MADE TO RE-OPERATE IN ORDER TO RECAPTURE THE DEVICE. THE DEVICE WAS SUCCESSFULLY RECAPTURED USING A SNARE, AND THE CLINICAL TEAM ELECTED TO IMPLANT A LARGER DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310286 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER DEVELOPED A SMALL BULBOUS SHAPE. ATTEMPTS WERE MADE TO CORRECT THIS BY REMOVING, REFLUSHING, AND ALLOWING THE DEVICE TO REFORM IN HEPARINIZED SALINE BEFORE REDEPLOYMENT; HOWEVER, THE LEFT DISC CONTINUED TO SHOW THE BULBOUS DEFORMATION. THE PROCEDURE WAS COMPLETED USING A 25 MM AMPLATZER TALISMAN OCCLUDER. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY 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 23950631 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON(B)(6) 2025, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS IMPLANTED IN THE PATIENT USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. ON (B)(6) 2025, THE PATIENT HAD A PULMONARY EMBOLISM WITH OCCLUSION OF RIGHT MEDIAL BASAL SEGMENTAL PULMONARY ARTERY AND MEDICATIONS WERE PRESCRIBED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Coronary obstruction/occlusion; Pulmonary Embolism

  MAUDE report 23888025 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER DEPLOYING BOTH DISCS, IT WAS NOTED THAT THE DEVICE HAD AN ABNORMAL, BULKY APPEARANCE. THEREFORE, THE DEVICE WAS RE-SHEATHED AND REDEPLOYED; HOWEVER, THE SAME ISSUE PERSISTED. UPON INSPECTION AT THE TABLE, THE DEVICE WAS CLEARLY DEFORMED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW 25 MM AMPLATZER CRIBRIFORM OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY 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 23709262 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE WHILE IMPLANTING, THE RIGHT DISC OF THE OCCLUDER WAS DEFORMED INTO BULBOUS DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING AN 25MM AMPLATZER CRIBRIFORM OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY 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 23623917 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE LEFT DISC OF THE OCCLUDER WAS NOTED TO HAVE A BULGING EFFECT. THE PROCEDURE WAS COMPLETED USING A NEW 25MM AMPLATZER CRIBRIFORM SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY 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 23622594 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TREVISIO DELIVERY SYSTEM.DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SPACING BETWEEN THE TWO DISCS WAS CONSIDERED EXCESSIVE, AND BULGING OF THE RIGHT DISC WAS NOTED. UPON RECAPTURE, DEFORMATION OF THE DEVICE WAS IDENTIFIED ON THE TABLE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A 25MM TALISMAN OCCLUDER, WHICH WAS POSITIONED MORE FAVORABLY ON THE SEPTUM.THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY 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 23573277 ↗
• MalfunctionOct 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE IMPLANTATION, THE OCCLUDER TOOK FORM OF A BULBOUS DEFORMATION IN THE LEFT ATRIAL PORTION EVEN AFTER REPOSITIONING NUMEROUS TIMES. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A DIFFERENT 25MM AMPLATZER CRIBRIFORM. IT WAS NOTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337107 ↗
• MalfunctionAug 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE DEVICE WAS EXPANDING INSIDE THE BODY THE DEVICE HAD A BULBOUS DEFORMATION. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WAS REPORT OF CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. A NEW 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN AND DEPLOYED WITH THE SAME 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865821 ↗
• MalfunctionJul 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532442 ↗
• MalfunctionJul 14, 2025Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion; Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEVICE PREPARATION, A FIBER WAS OBSERVED AT THE OUTER ASPECT AT THE SEWING POINT ON THE PATCH. HOWEVER, THE DEVICE WAS PREPPED AND "THIS WAS NO LONGER AN ISSUE." HOWEVER, DURING DEPLOYMENT, BOTH THE LEFT ATRIAL (LA) AND RIGHT ATRIAL (RA) DISCS DEFORMED WITH A BULBOUS SHAPE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES AND NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE OCCLUDER WAS RETRACTED AND RE-DEPLOYED TWO MORE TIMES, HOWEVER THE DEFORMATION PERSISTED. THE OCCLUDER WAS EXCHANGED FOR A NEW 25MM AMPLATZER CRIBRIFORM OCCLUDER, WHICH ALSO DEFORMED WITH BULBOUS SHAPES IN BOTH THE LA AND RA DISCS. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES AND NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE SECOND OCCLUDER AS REMOVED AND EXCHANGED FOR A NEW 35-25MM AMPLATZER TALISMAN PFO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503579 ↗
• InjuryJun 27, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. ON (B)(6) 2025, THE DEVICE WAS FOUND TO HAVE EMBOLIZED INTO THE ABDOMINAL AORTA. PERCUTANEOUS RETRIEVAL WAS PERFORMED TO REMOVE THE DEVICE. THE PATIENT REMAINED STABLE AND WILL RECOVER. A FOLLOW-UP PROCEDURE WAS DISCUSSED TO CLOSE THE ASD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346471 ↗
• MalfunctionApr 24, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEVICE PREPARATION, OR MORE SPECIFICALLY, DURING THE FLUSHING PROCESS, THE OCCLUDER COULD NOT BE PURGED OF AIR. THE EXTENSION OF THE 8F TREVISIO SHEATH WAS LEAKING, LOSING WATER AND DRAWING IN AI AND AN AIR-FREE FLUSHING PROCESS COULD NOT BE ACHIEVED, SO THE SHEATH WAS REPLACED. A NEW 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN AND THE DEVICE WAS THEN ABLE TO BE PURGED OF AIR WITHOUT ANY PROBLEMS. WHEN THE DEVICE WAS PLACED IN THE FOSSA, THE RIGHT DISC DID NOT UNFOLD PROPERLY OR WAS UNFOLDED INCORRECTLY. IT WAS VERY CUP-SHAPED AND NOT A NICE DISC. EVEN A LITTLE PUSH WITH THE SHEATH, DID NOT HELPED TO FORM THE DISC PROPERLY. 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 DEVICE WAS THEN RETRACTED AND DISCARDED. THE PHYSICIAN DECIDED TO USE A 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903584 ↗
• InjuryApr 7, 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 4-YEAR-OLD PATIENT BROUGHT TO THE CARDIAC CATHETERIZATION (CATH) LABORATORY FOR PATENT DUCTUS ARTERIOSUS (PDA) AND ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE. THE PDA CLOSURE WAS DONE FIRST AND WITHOUT INCIDENT USING A 3 MM X 6 MM AMPLATZER PICCOLO OCCLUDER. NEXT ASD WAS CLOSURE ATTEMPTED WITH A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM. UPON DEPLOYMENT OF THE OCCLUDER ON THE SEPTUM, THE PATIENT WAS NOTED TO HAVE DEVELOPED 2ND DEGREE HEART BLOCK. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS OBSERVED FOR APPROXIMATELY 10MINS AT WHICH POINT CONVERTED SPONTANEOUSLY BACK TO NORMAL SINUS RHYTHM. THE DEVICE WAS THEN RELEASED FROM THE CABLE AND THE PATIENT WAS NOTED TO HAVE GONE BACK IN SECOND DEGREE HEART BLOCK. THE PATIENT WAS AGAIN MONITORED AND ELECTROPHYSIOLOGIST (EP) WAS CONSULTED. THE RECOMMENDATION WAS MADE TO ADMINISTER A DOSE OF STEROIDS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND EVENTUALLY CONVERTED BACK TO NORMAL SINUS RHYTHM APPROXIMATELY 30 MINUTES AFTER THE DEVICE WAS RELEASED. THE PATIENT WAS SENT BACK TO THE ROOM AND KEEP ON TELEMETRY MONITORING OVER NIGHT. THE NEXT MORNING THE PATIENT WAS NOTED TO

  Patient problems: Heart Block

  MAUDE report 21787483 ↗
• MalfunctionApr 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE ON TRANSESOPHAGEAL ECHOCARDIOGRAM AND FLUOROSCOPY, THAT BOTH LOBES OF THE OCCLUDER EXHIBITED A TULIP DEFORMATION WHEN BEING DEPLOYED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND THE OCCLUDER WAS NOT MISHANDLED OR DAMAGE AT ANY POINT DURING DEVICE PREP. THE DECISION WAS MADE TO REMOVE THE 25MM AMPLATZER CRIBRIFORM OCCLUDER AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS FINE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774077 ↗
• MalfunctionFeb 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 21438115 ↗
• MalfunctionJan 13, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139167 ↗
• InjuryJan 6, 2025Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZING OF THE DEVICE WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE DEVICE WAS SUCCESSFULLY IMPLANTED AFTER STABILITY TEST. ON (B)(6) 2024, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND IT WAS NOTED THAT THE DEVICE WAS NO LONGER AT THE INTRA ATRIAL SEPTUM PLACE. THE DEVICE WAS FOUND AT THE ABDOMINAL AORTA LEVEL. THE PHYSICIAN USED A SNARE AND ALLIGATOR FORCEPS TO CATCH THE DEVICE AT THE ABDOMINAL AORTA LEVEL AND IT WAS POSSIBLE TO PULL THE DEVICE INSIDE A 16F LONG INTRODUCER AND IT GOT REMOVED. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079976 ↗
• MalfunctionJan 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. IT WAS NOTED DURING PROCEDURE THAT THE THE LEFT DISC OF THE OCCLUDER EXHIBITED A TULIP DEFORMATION WHEN DEPLOYED. THE 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS NO MISHANDLED OR DAMAGED DURING DEVICE PREPARATION. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO KNOWN INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED, BUT THERE WAS A SLIGHT DELAY. THE DECISION WAS MADE TO REMOVE THE DEFORMED OCCLUDER AND REPLACE IT WITH ANOTHER ONE OF THE SAME MODEL AND SIZE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071452 ↗