Amplatzer™ Septal Occluder (REF 9-ASD-017)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00811806010144), received between Aug 21, 2018 and Sep 25, 2026 — classified as 13 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (31 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903201 ↗
• MalfunctionApr 23, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING PROCEDURE, A COBRA DEFORMATION WAS NOTED IN THE DEVICE. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WAS NO 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 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND DEPLOYED USING THE SAME DELIVERY SYSTEM. THERE WAS NO REPORTED ADVERSE CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969845 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING DEVICE PREPARATION, IT WAS OBSERVED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND IT WAS FORMING COBRA DEFORMATIONS ON BOTH SIDES. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE DEVICE DID NOT MAKE ANY CONTACT WITH THE PATIENT. 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 24475448 ↗
• InjuryFeb 13, 2026Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 18MM AMPLAZTER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM FOR A CLOSURE OF A POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD) IN A PATIENT WHO HAD EXPERIENCED A MYOCARDIAL INFARCTION APPROXIMATELY 10 DAYS EARLIER. DURING THE PROCEDURE, THE LEFT DISC OF THE OCCLUDER WAS DEPLOYED IN THE LEFT VENTRICLE AS INTENDED. HOWEVER, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING WAS LIMITED DUE TO INTERFERENCE ATTRIBUTED TO AN IMPELLA PUMP POSITIONED IN THE AORTA, RESULTING IN DIFFICULTY VISUALIZING AND GUIDING THE DEVICE TO AN OPTIMAL POSITION. IT WAS STATED THAT THE PHYSICIAN ELECTED TO RECAPTURE THE LEFT DISC AND ATTEMPT REDEPLOYMENT CLOSER TO THE VENTRICULAR SEPTUM. UPON REDEPLOYMENT, THE LEFT DISC FORMED A ¿COBRA HEAD¿ CONFIGURATION. 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 DEVICE WAS THEN RECAPTURED AND REMOVED WITHOUT INCIDENT. BECAUSE THE DELIVERY SHEATH REMAINED POSITIONED ACROSS THE DEFECT WITHIN THE LEFT VENTRICLE, THE PHYSICIAN EXCHANGED AND UPSIZED T

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24335061 ↗
• MalfunctionFeb 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 7F ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE, IT SWELLED UP AND DID NOT OPEN. THE PROCEDURE WAS COMPLETED USING A NEW 17MM AMPLATZER SEPTAL 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 24283888 ↗
• InjuryDec 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY FIVE MONTHS AFTER UNDERGOING AN ATRIAL SEPTAL DEFECT (ASD) IMPLANT PROCEDURE. A 17MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN (B)(6) 2025 FOR CLOSURE OF A PATENT FORAMEN OVALE (PFO). THE DEVICE WAS REPORTED TO BE IN GOOD POSITION AT IMPLANT AND PRIOR TO THE PATIENT BEING DISCHARGED HOME. SUBSEQUENT EVALUATION REVEALED THAT THE PFO WAS FENESTRATED AND ANEURYSMAL IN NATURE (MULTIFENESTRATED, ANEURYSMAL DEFECT). THE SIZING OF THE DEVICE WAS DETERMINED BY BALLOON SIZING, AS IT WAS A FENESTRATED SEPTUM AND ANEURYSMAL. DURING THE RECENT HOSPITALIZATION, ON (B)(6) 2025, IT WAS IDENTIFIED THAT THE OCCLUDER HAD EMBOLIZED INTO THE AORTA. THE EMBOLIZATION WAS IDENTIFIED BY TTE, THEN CONFIRMED BY ANGIOGRAM. AT THE TIME OF REPORTING, THE EMBOLIZED DEVICE DOES NOT APPEAR TO BE CAUSING ANY CLINICAL ISSUES FOR THE PATIENT. THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION MAY HAVE BEEN UNDERSIZING. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE DEVICE; THE PATIENT HAS HAD A CATHETER, AND THE DEVICE IS CONSIDERED TO BE IN A REASONABLE POSITION NOT TO CAUSE SIGNIFICANT DAMAGE. THERE APPEARS TO BE NO OBSTRUCTION

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709259 ↗
• MalfunctionDec 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER EXHIBITED A COBRA-LIKE DEFORMATION DURING DEPLOYMENT. THE DEFORMED DEVICE WAS SUBSEQUENTLY RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS THEN PLACED IN WARM SALINE FOR FIVE MINUTES, AFTER WHICH IT RETURNED TO ITS ORIGINAL SHAPE. THE DEVICE WAS REINTRODUCED AND INITIALLY DISPLAYED SLIGHT DEFORMATION; HOWEVER, IT FULLY CONFORMED TO ITS INTENDED SHAPE AFTER DEPLOYMENT. THE DISC WAS SUCCESSFULLY IMPLANTED WITHOUT ANY DEFORMATION OR ALTERATIONS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY OCCURRED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708819 ↗
• MalfunctionOct 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING THE 8F AMPLATZER TREVISO DELIVERY SYSTEM. THE DEVICE WAS INTENDED TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). DURING THE PROCEDURE, AS THE DEVICE WAS EXPANDING INSIDE THE BODY, IT EXHIBITED A BULBOUS DEFORMATION. THE DEFORMED OCCLUDER WAS RETRIEVED FROM THE PATIENT PRIOR TO ITS RELEASE FROM THE DELIVERY SYSTEM. IT WAS NOTED THAT CONTACT OCCURRED WITH INTRACARDIAC TISSUES DURING THE DEPLOYMENT OF THE OCCLUDER. NO BENDS OR KINKS WERE OBSERVED IN THE DELIVERY SHEATH. THE PROCEDURE WAS COMPLETED USING AN 18 MM AMPLATZER SEPTAL OCCLUDER, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430686 ↗
• MalfunctionSep 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT OCCLUDER TOOK FORM OF COBRA DEFORMATION. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 16 MM AMPLATZER SEPTAL OCCLUDER. IT IS REPORTED THAT THE PATIENT IS HEMODYNAMICALLY STABLE WITH NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067027 ↗
• MalfunctionJul 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, A COBRA BULGING ON THE LEFT-ATRIAL DISC WAS NOTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. 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 REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631731 ↗
• MalfunctionJun 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE AND WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SHEATH. 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 22285679 ↗
• MalfunctionApr 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT'S ATRIAL SEPTAL DEFECT WAS MEASURED AT 14MM ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). AN 18MM AMPLATZER SIZING BALLOON WAS USED TO MEASURE THE DEFECT AT 15MM. THE AORTIC RIM MEASURED AT 3MM, THEREFORE THE 17MM OCCLUDER WAS SELECTED. DURING IMPLANT THE LEFT DISC OF THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 18MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. 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 TO 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 21875141 ↗
• MalfunctionFeb 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 8F SHEATH. WHILE DEPLOYING THE DEVICE, IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE, NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM, OR INTERACTION WITH CARDIAC STRUCTURES. THE PHYSICIAN DOESN'T BELIEVE THAT THE PATIENT EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423036 ↗
• MalfunctionFeb 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. USING AN UNKNOWN SIZED ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER DEFORMED WITH A COBRA SHAPE IN THE LEFT ATRIAL DISC. THERE WERE NO INTERACTIONS 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. THE DEVICE WAS EXCHANGED FOR A NEW 17MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414615 ↗
• MalfunctionJan 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. 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. A NEW 17MM AMPLATZER SEPTAL OCCLUDER AND A NEW 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120621 ↗
• MalfunctionJan 6, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, AN ATTEMPT WAS MADE TO PLACE THE DEVICE, BUT THE LEFT ATRIAL DISC FORMED A COBRA HEAD SHAPE, SO IT WAS RETRIEVED AND REPLACED WITH THE SAME SIZE AND LOT NUMBER. A NEW 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, ANOTHER ATTEMPT WAS MADE TO PLACE IT, BUT IT AGAIN FORMED A COBRA HEAD SHAPE. THE DEFORMED DEVICES WERE 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. THEREFORE, THE PROCEDURE WAS TERMINATED WITHOUT PLACEMENT, AND A RESCHEDULED DATE WAS PLANNED. THE PATIENT WAS REPORTED STABLE AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080130 ↗
• MalfunctionJan 6, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, AN ATTEMPT WAS MADE TO PLACE THE DEVICE, BUT THE LEFT ATRIAL DISC FORMED A COBRA HEAD SHAPE, SO IT WAS RETRIEVED AND REPLACED WITH THE SAME SIZE AND LOT NUMBER. A NEW 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, ANOTHER ATTEMPT WAS MADE TO PLACE IT, BUT IT AGAIN FORMED A COBRA HEAD SHAPE. THE DEFORMED DEVICES WERE 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. THEREFORE, THE PROCEDURE WAS TERMINATED WITHOUT PLACEMENT, AND A RESCHEDULED DATE WAS PLANNED. THE PATIENT WAS REPORTED STABLE AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080084 ↗
• MalfunctionJan 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 16MM AMPLATZER SEPTAL 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069446 ↗
• MalfunctionNov 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, A COBRA DEFORMATION WAS OBSERVED IN THE LEFT ATRIAL DISC. SEVERAL ATTEMPTS WERE MADE TO RESTORE IT, BUT THEY WERE UNSUCCESSFUL. DUE TO CONCERNS ABOUT POTENTIAL EROSION BASED ON ITS SHAPE, IT WAS NOT RELEASED AND WAS INSTEAD RETRIEVED. A NEW 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN BUT NOT PLACED DUE TO MORPHOLOGICAL MISMATCH AND CONCERNS ABOUT EROSION. 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 DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748051 ↗
• MalfunctionNov 4, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). DURING THE PROCEDURE, THE LEFT DISC OF THE DEVICE WAS DEPLOYED IN THE LEFT ATRIUM, AND THE OCCLUDER DID NOT FORM INTO THE STANDARD DISC AND WAIST SHAPE. THE DEVICE WAS RESHEATHED AND REDEPLOYED WITHOUT IMPROVEMENT. AFTER ANOTHER UNSUCCESSFUL ATTEMPT, THE DEVICE WAS REMOVED AND REPLACED WITH AN 18MM AMPLATZER SEPTAL OCCLUDER. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTED 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. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601675 ↗
• MalfunctionOct 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Advance

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566988 ↗
• MalfunctionSep 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT DISC BECAME A COBRA HEAD. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE 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 17MM AMPLATZER SEPTAL OCCLUDER AND A NEW 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280483 ↗
• MalfunctionSep 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS PREPARED AS PER INSTRUCTIONS FOR USE (IFU). DURING PROCEDURE, WHILE RELEASING THE LEFT ATRIAL DISC, IT HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. 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 PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258604 ↗
• MalfunctionAug 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A ATRIAL SEPTAL DEFECT (ASD) CLOSURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEFECT SIZE WAS 13MM X 7MM ON 3D TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND 16MM WITH SIZING BALLOON UNDER FLUOROSCOPY AND 18MM WITH SIZING BALLOON UNDER TEE. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS OF THE USE (IFU) BUT DURING DEPLOYMENT THE LEFT DISC SHOWED A COBRA HEAD DEFORMITY. THE DEVICE WAS RECAPTURED AND DEPLOYED AGAIN BUT STILL HAD THE COBRA HEAD SHAPE. THE DEVICE WAS THEN RETRIEVED AND PHYSICIAN DEPLOYED THE DEVICE ON TABLE BUT COULDN'T REPRODUCE THE COBRA HEAD SHAPE, THE DEVICE LOOKED NORMAL BUT THE TWO DISCS WERE FLAT. 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 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY DEPLOYED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046984 ↗
• MalfunctionAug 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON 29 JULY 2024, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SCELETED FOR AN IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER BECAME COBRA HEAD AND WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING OCCLUDER DEPLOYMENT AND THERE WERE NOT BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. THE OCCLUDER WAS REPLACED TO NEW 17MM AMPLATZER SEPTAL OCCLUDER USING THE SAME DELIVERY SHEATH, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013289 ↗