Amplatzer™ Septal Occluder (REF 9-ASD-009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00811806010069), received between Jan 4, 2019 and Aug 14, 2026 — classified as 1 death, 6 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (29 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261322 ↗
• MalfunctionApr 22, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLAINT USING A 6F AMPLATZER TREVISIO DELIVERY SYSTEM . DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM WAS DAMAGED, WHICH IN TURN LED THE OCCLUDER TO CONFORM INTO A SNAKE-LIKE DEFORMATION. THE DELIVERY SYSTEM HAD BEEN INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED AT THAT TIME AND DID COME IN CONTACT WITH THE PATIENT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 6F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFORMATION OF THE OCCLUDER WAS DESCRIBED AS A COBRA SHAPE AND WAS NOTED DURING IMPLANTATION WHEN THE DEVICE WAS OPENED BUT NOT RELEASED FROM THE DELIVERY CABLE. NO INTERACTION WITH CARDIAC STRUCTURES OCCURRED DURING DEPLOYMENT, AND THE DEVICE OPENED NORMALLY ONCE THE DELIVERY SYSTEM WAS EXCHANGED. THE DAMAGE TO THE DISTAL SHEATH TIP WAS IDENTIFIED AFTER THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT FOLLOWING OBSERVATION OF THE COBRA-SHAPED DEFORMATION AND SUBSEQUENT INSPECTION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE OCCLUDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961477 ↗
• MalfunctionFeb 10, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307591 ↗
• MalfunctionFeb 9, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, THE PATIENT RECEIVED TWO MITRACLIPS TO TREAT MITRAL REGURGITATION. THE PATIENT WAS HOSPITALIZED FOR INTERVENTION ON (B)(6) 2025 DUE TO DECOMPENSATED HEART FAILURE RESULTING FROM RECURRENT MR GRADE 4+ AND MITRAL PRESSURE GRADIENT 7MMHG. BOTH CLIPS WERE IN PLACE BUT THE LATERAL CLIP SHOWED MOVEMENT AND TILT. A MITRACLIP XT WAS SUCCESSFULLY PLACED LATERAL OF THE TWO PRE-EXISITING CLIPS, REDUCING MR TO GRADE 2-3 AND PRESSURE GRADIENT TO 6MMHG. AN ADDITIONAL MITRACLIP NT WAS ATTEMPTED TO BE PLACED MEDIAL OF THE PRE-EXISTING CLIPS - GRASP WAS SUCCESSFUL AND REDUCED MR SIGNIFICANTLY, BUT GRADIENT INCREASED TO 14MMHG. IT WAS DECIDED TO REMOVE THIS CLIP. GRADIENT WENT BACK DOWN TO 6MMHG. THERE WERE NO ISSUES WITH THE NT CLIP. AFTER THE SUCCESSFUL MITRAL INTERVENTION, IT WAS DECIDED TO TREAT THE IATROGENIC ATRIAL SEPTAL DEFECT STILL REMAINING FROM THE ORIGINAL MITRACLIP PROCEDURE. A 9MM AMPLATZER ATRIAL SEPTAL DEFECT (ASD) OCCLUDER WITH A 10F TREVISIO DELIVERY SHEATH WAS ATTEMPTED TO BE IMPLANTED. DURING DEPLOYMENT THE OCCLUDER DEFORMED INTO A COBRA SHAPE. THE OCCLUDER WAS REMOVED, AND THE DEFORMATION STILL REMAINED OUTSIDE THE PATIENT. PHYSIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299880 ↗
• MalfunctionDec 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809447 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM FOR THE CLOSURE OF SECUNDUM ATRIAL SEPTAL DEFECT. DURING THE PROCEDURE, DEFORMATION OF THE LEFT ATRIAL DISC WAS OBSERVED DURING DEPLOYMENT IN THE LEFT ATRIUM. THE DEVICE DEFORMED INTO COBRA-LIKE DEFORMATION. MULTIPLE ATTEMPTS WERE MADE TO DEPLOY AND USE THE DEVICE, BUT DEPLOYMENT WAS UNSUCCESSFUL DUE TO THE 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 A NEW 9MM AMPLATZER SEPTAL OCCLUDER. 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 23571026 ↗
• MalfunctionOct 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 23214166 ↗
• MalfunctionOct 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM . DURING THE PROCEDURE, THE COBRA DEVICE DEFORMATION OCCURRED WHILE EXPANDING THE DEVICE WITHIN THE PATIENT'S ANATOMY. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY PRIOR TO BEING RELEASED FROM THE DELIVERY CABLE. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN USING THE SAME DELIVERY SYSTEM, A COBRA DEVICE DEFORMATION OCCURRED AGAIN. THE DEFORMED DEVICE WERE RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. IT WAS OBSERVED THAT A THROMBUS HAD DEVELOPED ON THE 8F DELIVERY SYSTEM. THE THROMBUS DID NOT HAVE UNUSUAL OR FIBER LIKE APPEARANCE. IT WAS NOTED THAT THE SHEATH WAS IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME DUE TO THE DEFORMATIONS. THE ACTIVATED CLOTTING TIME (ACT) LEVEL WAS NOTED AS 250 DURING THE PROCEDURE, HOWEVER IT WAS NOTED THAT IT WAS DIFFICULT TO PROLONG AND ADDITIONAL HEPARIN WAS ADMINISTERED. THE PATIENT DID NOT HAVE ANY HEMATOLOGICAL DISORDERS OR SYSTEMIC ILLNESS TO CONTRIBUTE TO THE HYPERCOAGULABILITY. THE PROCEDURE WAS COMPLETED USING AN 8MM AMPLATZER SEPTAL OCCLUDER AND NEW DELIVER S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214085 ↗
• MalfunctionOct 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE COBRA DEVICE DEFORMATION OCCURRED WHILE EXPANDING THE DEVICE WITHIN THE PATIENT'S ANATOMY. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY PRIOR TO BEING RELEASED FROM THE DELIVERY CABLE. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN USING THE SAME DELIVERY SYSTEM, A COBRA DEVICE DEFORMATION OCCURRED AGAIN. THE DEFORMED DEVICE WERE RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. IT WAS OBSERVED THAT A THROMBUS HAD DEVELOPED ON THE 8F DELIVERY SYSTEM. THE THROMBUS DID NOT HAVE UNUSUAL OR FIBER LIKE APPEARANCE. IT WAS NOTED THAT THE SHEATH WAS IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME DUE TO THE DEFORMATIONS. THE ACTIVATED CLOTTING TIME (ACT) LEVEL WAS NOTED AS 250 DURING THE PROCEDURE, HOWEVER IT WAS NOTED THAT IT WAS DIFFICULT TO PROLONG AND ADDITIONAL HEPARIN WAS ADMINISTERED. THE PATIENT DID NOT HAVE ANY HEMATOLOGICAL DISORDERS OR SYSTEMIC ILLNESS TO CONTRIBUTE TO THE HYPERCOAGULABILITY. THE PROCEDURE WAS COMPLETED USING AN 8MM AMPLATZER SEPTAL OCCLUDER AND NEW DELIVER S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214020 ↗
• MalfunctionSep 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER TOOK FORM OF A COBRA DEFORMATION, THE PHYSICIAN REMOVED, RINSED AND TRIED TO IMPLANT THE OCCLUDER, WHICH AGAIN TOOK FORM OF A COBRA DEFORMATION. IT WAS NOTED THAT THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. IT WAS ALSO OBSERVED THAT THERE WERE NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK IN THE DELIVERY SYSTEM. A NEW 8MM AMPLATZER SEPTAL OCCLUDER WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059852 ↗
• MalfunctionSep 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER TOOK THE FORM OF COBRA AND FAILED TO BE SUCCESSFULLY RE-SHAPED SEVERAL TIMES. A NEW 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS REPORTED STABLE AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007881 ↗
• MalfunctionJun 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE PHYSICIAN GOING TO RELEASE THE FIRST DISC OF OCCLUDER FROM THE LEFT UPPER PULMONARY VEIN (LUPV), IT BECAME IN COBRA POSITION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE, PUT IT IN WARM WATER, BUT IN THE SECOND ATTEMPT THE LEFT DISC WAS STILL RELEASING IN COBRA. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THEY DECIDED TO USE A NEW 10MM AMPLATZER SEPTAL OCCULDER. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE EVENT AND PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363867 ↗
• MalfunctionMar 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) USING A8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE DEVICE WAS EXPANDING INSIDE THE BODY IT HAD A COBRA DEFORMATION. 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 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED WITH THE SAME DELIVERY SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT THE PATIENT WAS REPORTED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718516 ↗
• MalfunctionOct 14, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE DEVICE WAS PARTIALLY RE-CAPTURED ONCE. WHILE ATTEMPTING TO DEPLOY THE DEVICE A SECOND TIME, THE DEVICE TOOK ON A COBRA SHAPE IN THE LEFT ATRIUM. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS RE-LOADED AND RE-DEPLOYED OUTSIDE OF THE PATIENT BUT DEFORMED INTO A COBRA SHAPE AGAIN. THE DEVICE WAS REPLACED WITH A NEW 8MM 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 20440795 ↗
• InjuryOct 8, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZE OF ASD MEASURED BY ECHOCARDIOGRAM (ECHO) WAS 6MM AND THE AORTIC EDGE WAS 6MM. DURING PROCEDURE, THE OCCLUDER WAS PLACED ECHOCARDIOGRAPHY WITH GOOD POSITIONING, THE MINNESOTA MANEUVER WAS PERFORMED WITH GOOD STABILITY, THE DEVICE WAS RELEASED, IMAGES ARE TAKEN AND THE DEVICE WAS WELL IMPLANTED. THIRTY-SIX HOURS LATER, PATIENT STARTED TO VOMIT AND A CHEST X-RAY WAS CONDUCTED, THE SPECIALIST CALLED AND INFORMED THE DEVICE WAS EMBOLIZED TO AORTA. THERE WAS A PARTIAL OBSTRUCTION DUE TO THE EMBOLIZED DEVICE. THE DEVICE WAS REMOVED VIA PERCUTANEOUS RETRIEVAL AND NEW MEASUREMENTS WERE TAKEN. NO BALLOONS WERE USED, 3D ECHO WAS USED AND A LARGER MEASUREMENT OF 11MM WAS FOUND. A NEW 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, WELL POSITIONED AND IMPLANTED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT WAS REPORTED STABLE AND SENT TO HOSPITAL FOR RECOVERY.

  Patient problems: Obstruction/Occlusion; Vomiting

  MAUDE report 20396635 ↗
• MalfunctionSep 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE OCCLUDER WAS RELEASED, IT CAME OUT OF THE SHEATH IN A COBRA SHAPE. THE DEVICE WAS RETRACTED. 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 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE SUCCESSFULLY. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259744 ↗
• MalfunctionSep 16, 2024Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE THE DEVICE TOOK ON A COBRA SHAPE WHEN OPENED IN THE LEFT ATRIUM. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE DEVICE WAS CORRECTED BACK TO ITS ORIGINAL SHAPE BEFORE BRING RE-INSERTED INTO THE PATIENT. DURING IMPLANT THE DEVICE TOOK ON A COBRA HEAD SHAPE AGAIN. THIS WAS REPEATED 1 ADDITIONAL TIME WITH THE SAME RESULTS. AFTER THE SECOND DEPLOYMENT ATTEMPT THE PATIENT WENT INTO HEART BLOCK. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THE DEVICE AND DELIVERY SYSTEM WERE BOTH REMOVED FROM THE PATIENT AND THE HEART BLOCK RESOLVED ON ITS OWN. A NEW 10MM AMPLATZER SEPTAL OCCLUDER AND UNKNOWN DELIVERY SYSTEM WERE USED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS NOR KINKS NOTED ON THE DELIVERY SYSTEM.

  Patient problems: Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226644 ↗
• MalfunctionSep 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER DEPLOYED AS A COBRA DEFORMATION. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 9MM AMPLATZER SEPTAL OCCLUDER. 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 AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162502 ↗
• MalfunctionAug 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953360 ↗
• MalfunctionJul 24, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 02 JULY 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM INTO AN ATRIAL SEPTAL DEFECT. DURING IMPLANT, THE LEFT DISC DEPLOYED WITH A COBRA HEAD. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO KINK/BENDS WERE OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW 9MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SHEATH. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818158 ↗
• MalfunctionJun 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, IT WAS NOTED THAT THE DEVICE DEPLOYED IN A COBRA DEFORMATION. THE DEVICE WAS TAKEN OUT OF THE DELIVERY SYSTEM 5-6 TIMES AND THE SHAPE WAS CORRECTED. THE DEVICE WAS LOADED AGAIN AND POSITIONED IN THE HEART, BUT UPON DEPLOYMENT RESULTED IN A COBRA DEFORMATION AGAIN. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINKS IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND REPLACED WITH A 10MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE, BUT NO ADVERSE EVENTS TO THE PATIENT AND IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520249 ↗
• MalfunctionMay 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT, DURING DEPLOYMENT, COBRA SHAPE WAS OBSERVED WITH THE LEFT DISC. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO KINK OR ANGULATION WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS REMOVED. THE OCCLUDER WAS EXCHANGED FOR A NEW 8MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279799 ↗
• MalfunctionApr 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO DEPLOY THE DEVICE AT LEFT ATRIAL INTO RIGHT ATRIAL THEN THE DEICE DEFORMED INTO A COBRA SHAPE. THE PHYSICIAN TOOK THE DEVICE OUT AND PREPARED AGAIN, BUT DURING DEPLOYMENT THE DEVICE AGAIN DEFORMED INTO COBRA SHAPE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, BUT DURING DEPLOYMENT THE DEVICE DEFORMED INTO A COBRA SHAPE. 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 PHYSICIAN CHANGED THE DEVICE INTO A NEW 10MM AMPLATZER SEPTAL OCCLUDER AND DEPLOYED SUCCESSFULLY. 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 19145261 ↗
• MalfunctionApr 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO DEPLOY THE DEVICE AT LEFT ATRIAL INTO RIGHT ATRIAL THEN THE DEICE DEFORMED INTO A COBRA SHAPE. THE PHYSICIAN TOOK THE DEVICE OUT AND PREPARED AGAIN, BUT DURING DEPLOYMENT THE DEVICE AGAIN DEFORMED INTO COBRA SHAPE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, BUT DURING DEPLOYMENT THE DEVICE DEFORMED INTO A COBRA SHAPE. 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 PHYSICIAN CHANGED THE DEVICE INTO A NEW 10MM AMPLATZER SEPTAL OCCLUDER AND DEPLOYED SUCCESSFULLY. 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 19145214 ↗
• MalfunctionApr 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT THE ATRIAL SEPTAL DEFECT. A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. BOTH DEVICES WERE DEPLOYED INTO THE PATIENT AT THE SAME TIME. DURING IMPLANT THE 8MM OCCLUDER TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 9MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE FIRST 9MM OCCLUDER TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093522 ↗