Amplatzer™ Septal Occluder (REF 9-ASD-022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00811806010182), received between Aug 29, 2018 and Sep 29, 2026 — classified as 1 death, 33 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (72 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration or Expulsion of Device

  Patient problems: Arrhythmia; Obstruction/Occlusion

  MAUDE report 50941056 ↗
• MalfunctionSep 23, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862985 ↗
• MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 22mm Amplatzer Septal Occluder was chosen for implant using a 9F Amplatzer Torqvue Delivery System. During the procedure, it was noted that the occluder did not take proper shape reulting in bulbous formation. It was reported that the physician recaptured left atrial disc of the device into the delivery sheath, then unsheathed to left atrial disc a second time. The left atrial disc maintained it's odd shape. 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. There was no interaction with cardiac structures during deployment. The implanter decided to replace the device. A new 22mm Amplatzer Septal occluder(Lot:10912084) was used as replacement device to complete the procedure. There was nothing that occurred during unpackaging or prepping the device that would have affected the shape of the left atrial disc. 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 50801819 ↗
• MalfunctionAug 24, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420141 ↗
• MalfunctionJul 10, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6)2025 that a 22 mm Amplatzer Septal Occluder was chosen for implant using a 9F Amplatzer Torqvue Delivery System. It was noted that the both the discs of the occluder were observed in Cobra shape. 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. There was no interaction with cardiac structures during deployment. 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 25785544 ↗
• MalfunctionJul 10, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2025 that a 22 mm Amplatzer Septal Occluder was chosen for implant using a 9F Amplatzer Torqvue Delivery System. It was noted that the both the discs of the occluder were observed in Cobra shape. 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. There was no interaction with cardiac structures during deployment. 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 25785474 ↗
• MalfunctionFeb 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER CONFORMS INTO A COBRA-LIKE DEFORMATION AFTER THE FIRST DISC WAS DEPLOYED AND IT COULDN'T RETURN TO ITS DESIRED SHAPE. THE PROCEDURE WAS COMPLETED USING A NEW 22MM 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 24405541 ↗
• InjuryFeb 6, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN9F AMPLATZER TREVISO DELIVERY SYSTEM FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPY GUIDANCE. THE ATRIAL SEPTAL DEFECT MEASURED APPROXIMATELY 21¿22 MM, AND DEVICE SIZING WAS DETERMINED BY BALLOON SIZING USING A 24 MM BALLOON. DURING THE PROCEDURE, MULTIPLE DEVICES WERE UTILIZED DUE TO DIFFICULTY ACHIEVING STABLE POSITIONING, INCLUDING 20 MM, 22 MM, AND 24 MM OCCLUDERS. THE INITIALLY ATTEMPTED 22 MM DEVICE COULD NOT BE POSITIONED DESPITE MULTIPLE DEPLOYMENT TECHNIQUES (LUPV, RUPV, AND LA DEPLOYMENT). A 20 MM DEVICE WAS THEN DEPLOYED BUT SUBSEQUENTLY PULLED THROUGH TO THE RIGHT ATRIUM DURING THE PUSH/PULL MANEUVER. A 24 MM DEVICE WAS DEPLOYED BUT WAS REMOVED AFTER IT WAS NOTED TO IMPINGE ON THE MITRAL VALVE. A SECOND ATTEMPT WITH A 22 MM DEVICE DEMONSTRATED NO MOVEMENT DURING PUSH/PULL TESTING, NO VALVE IMPINGEMENT, GOOD RIM CAPTURE, AND NO RESIDUAL DEFECT. A STABILITY CHECK WAS PERFORMED, AND NO LEAK WAS DETECTED. A 22 MM AMPLATZER SEPTAL OCCLUDER WAS ULTIMATELY SELECTED AND IMPLANTED USING AN UNKNOWN DEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283833 ↗
• MalfunctionFeb 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER¿S DISC EXHIBITED A COBRA-LIKE DEFORMATION UPON INITIAL DEPLOYMENT. THE DEVICE CONTINUED TO SHOW A BULGING DEFORMATION WHEN RETRIEVED OUTSIDE THE PATIENT AND DID NOT RETURN TO ITS INTENDED SHAPE AFTER A PERIOD OF OBSERVATION. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW 22 MM 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 24283832 ↗
• InjuryJan 20, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED USING AN UNKNOWN DELIVERY SYSTEM. THE AORTIC RIM MEASURED 2.9 MM, AND THE ORIGINAL ATRIAL SEPTAL DEFECT WAS 13 MM × 16 MM. BALLOON SIZING INDICATED A DIAMETER OF 21 MM, AND BASED ON THIS MEASUREMENT, A 22 MM DEVICE WAS SELECTED FOR IMPLANTATION. IT WAS NOTED THAT THERE WERE NO DIFFICULTIES IMPLANTING THE DEVICE. AT THE FOUR MONTH FOLLOW-UP ON (B)(6) 2025, TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED PERICARDIAL EFFUSION, ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DEMONSTRATED DEVICE PROTRUSION TOWARD THE AORTA WITH A 1.4-MM DENT, ALONG WITH ASD EFFUSION AND CARDIAC TAMPONADE EXTENDING UP TO THE ATRIUM. IT WAS NOTED THAT THE TAMPONADE HAD NOT REACHED THE AORTA (AO), BUT THE DEVICE WAS IN A STATE OF RUBBING AGAINST THE AORTIC WALL. ACCORDING TO THE OPERATIVE RECORD, THE AMPLATZER DEVICE PROTRUDED INTO THE ATRIUM TOWARD THE NON-CORONARY CUSP (NCC) OF THE VALSALVA SINUS. CONTUSION WAS OBSERVED ON THE ADVENTITIA OF THE AORTIC WALL, AND A KNOWN THROMBUS WAS IDENTIFIED BETWEEN THE AORTIC WALL AND THE ATRIUM. ON (B)(6) 2025, MINIMALLY INVASIVE CARDIAC SURGERY (MICS)

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 24122513 ↗
• MalfunctionJan 12, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036113 ↗
• DeathJan 5, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM UNKNOWN AMPLATZER OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE. THE DEVICE WAS SUCCESSFULLY DEPLOYED, AND THE PATIENT WAS TRANSFERRED FROM THE CARDIAC CATHETERIZATION LABORATORY TO THE HOSPITAL FLOOR IN STABLE CONDITION. ON (B)(6) 2025, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND REPORTED AS UNREMARKABLE. THE PATIENT WAS BEING PREPARED FOR DISCHARGE LATER THAT DAY AND REPORTEDLY CONSUMED A LARGE MEAL PRIOR TO THE PLANNED DISCHARGE. SUBSEQUENTLY, THE PATIENT EXPERIENCED CARDIAC ARREST ACCOMPANIED BY SIGNIFICANT VOMITING. AIRWAY MANAGEMENT WAS REPORTED TO BE CHALLENGING, WITH UNSUCCESSFUL INTUBATION ATTEMPTS FOR APPROXIMATELY 25 MINUTES, AFTER WHICH A TRACHEOSTOMY WAS PERFORMED TO SECURE THE AIRWAY. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM (OR). DURING SURGERY, THE IMPLANTED DEVICE WAS EXTRACTED, AND INTRAOPERATIVE FINDINGS REPORTEDLY INCLUDED EROSION WITH A 2 MM PERFORATION IN THE LEFT ATRIAL WALL AND A PINPOINT PERFORATION IN THE AORTA. THE ANATOMY WAS REPAIRED, AND THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION. THE P

  Patient problems: Cardiac Arrest; Erosion; Perforation

  MAUDE report 23967643 ↗
• MalfunctionDec 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTICED THAT THE DEVICE TOOK FORM OF A COBRA-LIKE 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 22MM AMPLATZER SEPTAL OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751082 ↗
• MalfunctionNov 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660841 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE TOOK FORM OF A COBRA 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 24MM 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 23622542 ↗
• MalfunctionOct 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE TOOK FORM OF A COBRA SHAPE AND ANOTHER 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT, THIS TOOK THE FORM OF A COBRA SHAPE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A 24MM AMPLATZER SEPTAL OCCLUDER. IT WAS NOTED THAT THERE WERE NO INTERACTIONS WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214167 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 26 AUGUST 2025, THREE AMPLATZER SEPTAL OCCLUDERS WERE CHOSEN FOR IMPLANT USING A 10 F AMPLATZER TREVISIO INTRAVASCULAT 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 CLINCALLY 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 23101184 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101183 ↗
• MalfunctionAug 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708370 ↗
• MalfunctionJun 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE WHILE IN THE LEFT ATRIUM. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 22MM 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 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 22214417 ↗
• MalfunctionJun 13, 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. DURING THE PROCEDURE, IT WAS FOUND THAT THE RIGHT DISC WAS DEFORMED IN A COBRA SHAPE. THE DEVICE WAS REPLACED WITH ANOTHER 20MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206056 ↗
• MalfunctionJun 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED INTO A "SQUASHED" AND COBRA-LIKE SHAPE. 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 WAS REMOVED. IT WAS EXCHANGED FOR A NEW 22MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152902 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS EXPERIENCING OPHTHALMIC HEADACHES AND REDNESS/ITCHING ON THE WRIST. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT.

  Patient problems: Headache; Inflammation

  MAUDE report 21928372 ↗
• InjuryApr 21, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT AN ATRIAL SEPTAL DEFECT (ASD) SHUNT. THE ASD WAS MEASURED AT 19.5MM UNDER ECHOCARDIOGRAM (ECHO). SIZING OF THE DEVICE WAS DETERMINED WITH A BALLOON AND STOP-FLOW TECHNIQUE. ANGIOGRAPHY AND ECHO WERE USED DURING THE PROCEDURE. A STABILITY CHECK WAS PERFORMED. UPON RELEASE OF THE OCCLUDER FROM THE DELIVERY CABLE THE OCCLUDER EMBOLIZED TO THE LEFT ATRIUM, CAUSING A PARTIAL BLOCKAGE. ATTEMPTS WERE MADE TO SNARE THE OCCLUDER BUT WERE UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO SURGERY WHERE THE OCCLUDER WAS SURGICALLY EXPLANTED AND THE ASD WAS SURGICALLY CLOSED. THE USER BELIEVED THE DEVICE EMBOLIZATION WAS DUE TO DEVICE UNDERSIZING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21874876 ↗
• MalfunctionApr 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F NON-ABBOTT DELIVERY SYSTEM (DS). DURING DEPLOYMENT OF THE DEVICE, IT WAS NOTED THAT THE OCCLUDER PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND WAS REMOVED FROM THE PATIENT. THERE WAS NO INTERACTIONS WITH CARDIAC STRUCTURES OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827867 ↗