Amplatzer™ Septal Occluder (REF 9-ASD-020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00811806010175), received between Jun 19, 2018 and Sep 17, 2026 — classified as 2 deaths, 34 injuries, 43 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 79 reports, in the reporter's own words as published by the FDA.

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

  It was reported that on (b)(6) 2026, a 20mm Amplatzer Septal Occluder was chosen for implant using 9F Amplatzer Trevisio Intravascular Delivery System. During the procedure, in an attempt to position the left disc of the occluder parallel to the interatrial septum, it was noted that the device was exposed and recaptured into the 9F Trevisio catheter approximately three times, after which it opened in a cobra shape configuration. The device was then removed, placed in warm saline, and returned to its original shape. It was reloaded into the same sheath and reintroduced into the patient; however, it continued to open in a cobra shape configuration. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. The device was replaced with an 18mm Amplatzer Septal Occluder; however, the procedure was completed unsuccessfully, as the physician was unable to align the device with the septum. According to the physician, the left atrium was small, and the aortic rim was short. Therefore, there was not enough space or support to maneuver the prosthesis into the correct release angle. The 18mm Amplatzer

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802009 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE AFTER OPENING THE LEFT DISC AND TOOK FORM OF COBRA-LIKE DEFORMATION. THE OCCLUDER WAS REMOVED AND IMMERSED IN WARM SALINE, BUT THE COBRA DEFORMATION CONTINUED TO BE PRESENT. 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 A NEW 22MM AMPLATZER 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 24597453 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. NO PERICARDIAL EFFUSION HAD BEEN NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS IN NORMAL AND CONSTANT RHYTHM AT THE TIME OF THE INTERVENTION. THERE WAS NO TRANSSEPTAL PUNCTURE PERFORMED, AS THE PROCEDURE INVOLVED ASD CLOSURE, AND NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES OCCURRED; THE WIRE WAS POSITIONED IN THE UPPER LEFT PULMONARY VEIN. DURING THE PROCEDURE, THE PATIENT DEVELOPED CARDIAC TAMPONADE. THE EFFUSION WAS NOTED AT THE LEVEL OF THE AORTA, IN THE FORM OF A LINEAR COLLECTION ADJACENT TO THE AORTA, AND WAS ASSOCIATED WITH SHEARING CAUSED BY THE PROSTHESIS, WHICH LED TO BLEEDING AT THE LEVEL OF THE AORTIC WOUND IN RELATION TO THE COMPOSITE AORTIC PROSTHESIS (CIA PROSTHESIS). THE USER BELIEVES THAT THE ABBOTT DEVICE WAS IMPLICATED, STATING THAT THE PROSTHESIS CAUSED THE SHEARING AT THE AORTA. THE TAMPONADE WAS MANAGED INTRAOPERATIVELY WITH FELTED STITCHES AND A REINFORCEMENT BANDAGE. NO ABNORMALITIES WERE OBSERVED ON THE AORTIC VALVE, AND THE PROSTHESIS REMAINED IN APPROPRIATE POSITION AT THE CONCLUSION OF THE INTERVENTION. POSTOPERATIVELY, THE PAT

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Shock

  MAUDE report 24536340 ↗
• MalfunctionFeb 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. THE 9F DELIVERY SYSTEM WAS REPORTEDLY PREPARED IN ACCORDANCE WITH THE IFU, WITH NO FAULT IDENTIFIED DURING PREPARATION. THE 20 MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS PREPARED, ATTACHED TO THE DELIVERY CABLE, AND LOADED INTO THE LOADER. WHILE PREPARING, RESISTANCE WAS REPORTEDLY FELT BY THE PHYSICIAN AS THE DEVICE WAS BEING LOADED INTO THE SHEATH. CONNECTIONS WERE REPORTEDLY CHECKED AND THE DEVICE WAS ADVANCED AGAIN, AFTER WHICH THE LEFT DISC WAS REPORTEDLY DEPLOYED. THE DEVICE REPORTEDLY APPEARED DEFORMED ON FLUOROSCOPY DURING DEPLOYMENT, AND IT WAS REPORTEDLY ADVISED THAT THE DEVICE BE RECAPTURED AND REMOVED FOR INSPECTION. 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. FOLLOWING REMOVAL, THE DEVICE WAS REPORTEDLY OBSERVED TO RETURN TO A NORMAL SHAPE OUTSIDE OF THE SHEATH. A SECOND 20MM AMPLATZER SEPTAL OCCLUDER WAS PREPARED; HOWEVER, THE SAME RESISTANCE WAS EXPERIENCED WHEN LOADING IT INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283836 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, THE PHYSICIAN OBSERVED THAT OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF COBRA-LIKE DEFORMATION. THEREFORE THE OCCLUDER WAS RETRIEVED BACK AND THE PROCEDURE WAS ABORTED. 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 24223954 ↗
• MalfunctionDec 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER ASSUMED A COBRA-LIKE CONFIGURATION AND REMAINED DEFORMED EVEN AFTER MASSAGE. 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 A NEW 20 MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687626 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLAINT USING A 6F NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE, WHILE DEPLOYING THE PHYSICIAN OBSERVED THAT THE DEVICE WAS NOT CONFORMING TO ITS ORIGINAL SHAPE. 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 DEFORMED DEVICE WAS RETRIEVED BACK. 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 23623984 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTED THAT THE DEVICE TOOK FORM OF A COBRA DEFORMATION. 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 OR KINK WAS NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 22MM AMPLATZER 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 23470126 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10 F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING POSITIONED, THE LEFT ATRIAL DISC OF THE OCCLUDER ASSUMED A COBRA CONFIGURATION. AFTER THREE ATTEMPTS AT IMPLANTATION, THE DEVICE WAS NOT IMPLANTED AND WAS REMOVED FROM THE PATIENT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTIONS WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION / KINK WAS NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 22MM AMPLATZER SEPTAL OCCLUDER USING 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 23460702 ↗
• MalfunctionOct 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271493 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, THREE AMPLATZER SEPTAL OCCLUDERS WERE CHOSEN FOR IMPLANT USING A 10 F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM . DURING THE PROCEDURE, COBRA TYPE DEFORMATION WAS OBSERVED IN ALL THREE OCCLUDERS CONSECUTIVELY AS EXPANDING INSIDE THE BODY. THE DEFORMED OCCLUDERS MADE CONTACT WITH INTRACARDIAC TISSUE DURING DEPLOYMENT BUT WERE RETRIEVED PRIOR TO RELEASE FROM THE DELIVERY CABLE WHILE INSIDE THE BODY. NO BENDS/KINKS WERE OBSERVED IN THE DELIVERY SHEATH. THE PROCEDURE WAS COMPLETED USING A 9MM AMPLATZER SEPTAL OCCLUDER. THE PROCEDURE DURATION WAS LONGER THAN EXPECTED. IT WAS REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY OBSERVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WERE NO ADVERSE EVENTS PRESENT IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100866 ↗
• MalfunctionAug 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON UNKNOWN DATE, A 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT, THE PHYSICIAN NOTED THAT COBRA FORMATION IN BOTH DISCS OF THE DEVICE. 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 PROCEDURE WAS ABANDONED. 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 22708352 ↗
• MalfunctionJul 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025 A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZE AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, WHEN THE DEVICE WAS DEPLOYED IT PRESENTED IN 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 DEVICE WAS REMOVED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546015 ↗
• DeathJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. PRIOR TO PROCEDURE, THE PATIENT'S CONDITION WAS GOOD. NO PERICARDIAL EFFUSION WAS OBSERVED PRIOR TO PROCEDURE. "VARIOUS STABILITY TESTS WERE PERFORMED," AND THE OCCLUDER WAS RELEASED FOR IMPLANT. POST-IMPLANT, NO PERICARDIAL EFFUSION WAS OBSERVED. THE PATIENT WAS REPORTED TO HAVE BEEN DOING WELL IN THE AFTERNOON FOLLOWING IMPLANT. ON (B)(6) 2025, IN THE MORNING, CARDIAC TAMPONADE WAS OBSERVED. ULTRASOUND WAS PERFORMED, WHICH SHOWED CIRCUMFERENTIAL PERICARDIAL EFFUSION THAT WAS SUBSEQUENTLY DRAINED SUCCESSFULLY AND THE PATIENT STABILIZED. HOWEVER, APPROXIMATELY ONE HOUR LATER, A SECOND TAMPONADE WAS OBSERVED AND THE PATIENT EXPERIENCED CARDIAC ARREST. THORACIC SURGERY ATTEMPTED TO OPEN THE CHEST TO VIEW THE WOUND BUT NOTED PULSATILE RED BLOOD EJECTION. THE PATIENT WAS REPORTED TO HAVE PASSED. THE CAUSE OF DEATH WAS SUSPECTED AS "PROBABLY AORTA EROSION."

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Erosion; Pericardial Effusion

  MAUDE report 22534572 ↗
• MalfunctionJul 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481830 ↗
• InjuryJun 27, 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 20MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT'S NOTED DURING PROCEDURE THAT THE OCCLUDER INITIALLY EXHIBITED A COBRA DEFORMATION, BUT WAS RECAPTURED AND HAD NORMAL CONFIGURATION ON THE SECOND DEPLOYMENT. POST-PROCEDURE, IT WAS NOTED VIA ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED AN ATRIAL FIBRILLATION RHYTHM DISORDER WITH A HEART RATE OF 220 BEATS PER MINUTE. THE PATIENT WAS ADMINISTERED 500MG OF CORDARONE. ON RETURN FROM CATHETERIZATION, THE ATRIAL FIBRILLATION SPONTANEOUSLY RESOLVED. THERE WAS NO PROLONGED HOSPITAL FOR MONITORING OF HEART RHYTHM. THE CAUSE OF THE PATIENT'S ATRIAL FIBRILLATION IS ATTRIBUTED TO IMPLANT OF THE 20MM AMPLATZER SEPTAL OCCLUDER THAT WAS LARGE FOR THE PATIENT'S BODY SURFACE AREA. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Atrial Fibrillation

  MAUDE report 22346897 ↗
• MalfunctionMar 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND WASHED WITH WATER. THE OCCLUDER WAS RE-INSERTED INTO THE PATIENT, HOWEVER THE OCCLUDER OPENED CROOKEDLY. SEVERAL ATTEMPTS WERE MADE TO CONFORM THE OCCLUDER BACK TO ITS ORIGINAL SHAPE. THE OCCLUDER DID NOT RETAIN ITS ORIGINAL SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 17MM 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 21620528 ↗
• MalfunctionMar 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFECT WAS BALLOON-SIZED TO 20MM BUT HAD A 3MM AORTIC RIM; TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS ALSO USED. DURING PROCEDURE, THE OCCLUDER WAS DEPLOYED IN THE LEFT ATRIUM. HOWEVER, THE LEFT DISC EXPERIENCED A COBRA DEFORMATION THAT PERSISTED DESPITE ATTEMPTS TO RE-FORM THE DEVICE. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. A NEW 22MM AMPLATZER SEPTAL OCCLUDER WAS THEN ATTEMPTED TO BE IMPLANTED USING THE SAME TREVISIO DELIVERY SYSTEM. HOWEVER, THIS DEVICE ALSO DEFORMED WITH A COBRA SHAPE. THE 22MM OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO KINK/ANGULATION WAS OBSERVED WITH THE DELIVERY SYSTEM. IT WAS EXCHANGED FOR ANOTHER 22MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED USING THE SAME TREVISIO DELIVERY SYSTEM. THE PATIENT NEVER EXPERIENCED A RHYTHM CHANGE DURING PROCEDURE AND REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610421 ↗
• MalfunctionFeb 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT INTO AN ATRIAL SEPTAL DEFECT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE, THAT THE OCCLUDER EXHIBITED A BULBOUS DEFORMATION WHEN BEING DEPLOYED INSIDE THE PATIENT. IT'S NOTED THAT CONTACT WITH INTRACARDIAC TISSUES DID OCCUR DURING DEPLOYMENT. THE DEFORMED OCCLUDER WAS RETRIEVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WERE NO BENDS OR KINKS OBSERVED IN THE 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DECISION WAS MADE TO REPLACE THE DEFORMED 20MM AMPLATZER SEPTAL OCCLUDER WITH A 19MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE, USING THE SAME 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453223 ↗
• MalfunctionDec 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT, THE LEFT ATRIAL (LA) DISC SLIPPED INTO THE DEFECT AND WAS TIPPING INTO THE RIGHT ATRIUM (RA). THEREFORE, THE LA DISC WAS MANIPULATED AND THEN THE RA DISC WAS DEPLOYED. THE OCCLUDER THEN DEFORMED WITH A COBRA SHAPE. BOTH DISCS WERE RETRACTED INTO THE SHEATH AND ATTEMPTED TO BE DEPLOYED AGAIN. HOWEVER, THE DEFORMATION PERSISTED. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS REMOVED. NO ANGULATION OR KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. OUTSIDE OF THE PATIENT, THE OCCLUDER WAS DEPLOYED AGAIN AND COBRA DEFORMATION WAS ONCE AGAIN OBSERVED. THE OCCLUDER WAS EXCHANGED FOR A NEW 22MM AMPLATZER SEPTAL OCCLUDER AS THE HOSPITAL DID NOT HAVE ANOTHER 20MM AMPLATZER SEPTAL OCCLUDER; THE 22MM WAS SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908011 ↗
• MalfunctionDec 5, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE DEPLOYING THE DEVICE, IT KEPT PRESENTING IN A COBRA DEFORMATION ON THE LEFT ATRIAL SIDE. THE DEVICE WASN'T IMPLANTED AND WAS REPLACED WITH A 24MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ANGULATION OF KINKS IN THE DS NOR INTERACTION WITH CARDIAC STRUCTURES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856675 ↗
• InjurySep 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, THE LEFT ATRIAL DISC PRESENTED IN A COBRA DEFORMATION. THE PHYSICIAN ATTEMPTED RECAPTURING THE DEVICE IN THE SHEATH A FEW TIMES, BUT THE DEFORMATION PERSISTED. THE DEVICE WAS DETACHED FROM THE DELIVERY CABLE AND NEEDED TO BE RETRIEVED WITH A SNARE. ANOTHER DEVICE WAS IMPLANTED TO RESOLVE THE EVENT. THERE WAS NO KINK IN THE DELIVERY SYSTEM OR INTERACTION WITH CARDIAC STRUCTURES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257144 ↗
• InjurySep 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFECT MEASURED 16 X 19MM ON 3D TEE AND 20MM ON BALLOON SIZING USING A 24MM AMPLATZER SIZING BALLOON. THE DEVICE WAS PREPARED PER IFU AND RELEASED FOLLOWING A SATISFACTORY STABILITY TEST. THE AORTIC RIM WAS LESS THAN 5MM, BUT THE STABILITY TEST SHOWED THE DEVICE WAS HOLDING FIRMLY IN PLACE. FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE UTILIZED DURING PROCEDURE. NO RHYTHMS CHANGES OR LEAK WAS DETECTED DURING THE IMPLANT PROCEDURE; NO DIFFICULTY IMPLANTING WAS REPORTED. ON (B)(6) 2024, TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND SHOWED THAT THE DEVICE HAD MOVED. IT WAS STILL ATTACHED TO SOME PART OF THE SEPTUM, BUT WAS DETACHED FROM THE AORTIC RIM. A FEW ATTEMPTS TO SNARE THE DEVICE USING A 30MM ENSNARE WAS MADE, HOWEVER IT WAS UNSUCCESSFUL AND THE DEVICE EMBOLIZED TO THE LEFT VENTRICLE. IT IS UNKNOWN IF THE DEVICE WAS CAUSING PARTIAL BLOCKAGE IN THE LEFT VENTRICLE. THE PHYSICIAN MANAGED TO PERCUTANEOUSLY SNARE THE DEVICE IN THE LEFT VENTRICLE AND RETRIEVED THE OCCLUDER FROM THE PATIENT. HOWEVER, SOME DAMAGE WAS DONE TO THE MITR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152880 ↗
• MalfunctionAug 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, IT COULD NOT BE PROPERLY SHAPED AND THE 2 DISCS DID NOT ALIGN PROPERLY. THEREFORE, IT WAS EXCHANGED FOR A NEW 24MM AMPLATZER SEPTAL OCCLUDER, BUT THIS DEVICE DEFORMED INTO A COBRA SHAPE. SUBSEQUENTLY, IT WAS EXCHANGED FOR A THIRD DEVICE AND A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED. HOWEVER, THIS DEVICE FAILED TO FORM CORRECTLY AS THE 2 DISCS WERE UNABLE TO ALIGN PROPERLY. ULTIMATELY, NO DEVICE WAS IMPLANTED AND THE PROCEDURE WAS NOT COMPLETED. NONE OF THE OCCLUDERS WERE RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT OR ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM WHILE ATTEMPTING ANY OF THE 3 OCCLUDERS. THE PATIENT WAS SAFELY TAKEN OFF THE OPERATING TABLE AND IS IN STABLE CONDITION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT PROLONGED PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112696 ↗
• MalfunctionAug 2, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT, WHEN THE DEVICE WAS DEPLOYED, THE LEFT DISC SHOWED A COBRA DEFORMATION. THE OCCLUDER WAS RE-SHEATHED AND DEPLOYED AGAIN, BUT THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 20MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19895592 ↗