Amplatzer™ Septal Occluder (REF 9-ASD-018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00811806010151), received between Jul 24, 2018 and Sep 18, 2026 — classified as 1 death, 27 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (21 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 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, an 18mm Amplatzer Septal Occluder was chosen for implant using an unknown delivery system to treat Atrial Septal Defect (ASD). During the procedure, upon release of device, the physician noted that the occluder shifted to the left atrial side of the aortic rim while remaining stable on the remaining rims. When the physician attempted to retrieve the device using a snare, the occluder was advanced completely into the left atrium. The device subsequently migrated into the left ventricle and then into the aorta. Femoral arterial access was obtained, and the physician successfully snared and retrieved the device. The patient was reported to be stable throughout the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819744 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  It was reported that on (b)(6) 2026, an 18mm Amplatzer Septal Occluder was chosen for implant using an unknown delivery system. After ASD intervention, it was noted that erosion was observed. The patient was transferred in surgery to remove device and was reported to be stable.

  Patient problems: Erosion

  MAUDE report 50801574 ↗
• InjuryAug 21, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, an 18mm Amplatzer Septal Occluder was chosen for implant using a 9F Amplatzer Trevisio Intravascular Delivery System. INo issue was noted with the device during the procedure. It was further reported that approximately 24 hours later, the implanter performed a bubble study, which was positive. On (b)(6) 2026, post-procedure, the device was retrieved percutaneously. No adverse events, clinical signs, or symptoms were reported during or after the procedure or retrieval. The implanter considered the event to be related to the procedure rather than the performance of the device. The patient was reported to be stable.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379419 ↗
• MalfunctionAug 18, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305064 ↗
• InjuryAug 7, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 18mm Amplatzer Septal Occluder was chosen for a procedure. After the implant, the 18mm device embolized into the aorta. They were able to retrieve the device The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176854 ↗
• MalfunctionApr 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE RIMS WERE THIN, AND BALLOON SIZING SHOWED A MAXIMUM MEASURABLE DIAMETER OF 19¿20 MM. THEREFORE, A 19MM DEVICE WAS SELECTED INITIALLY. DURING THE ATTEMPT TO IMPLANT INSIDE THE BODY, CONTINUOUS CONTACT WITH THE AORTA WAS OBSERVED, AND THE DEVICE WAS DETERMINED TO BE OVERSIZED. ADDITIONALLY, BECAUSE THE DEFECT MORPHOLOGY WAS ELLIPTICAL, IT WAS CONSIDERED THAT DOWNSIZING THE DEVICE WOULD NOT INCREASE THE RISK OF DEVICE EMBOLIZATION. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. THE DEVICE WAS THEREFORE CHANGED TO A NEW 18MM AMPLATZER SEPTAL OCCLUDER AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING CONFIRMED THAT THERE WERE NO ISSUES FOLLOWING DEVICE REPLACEMENT. 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 24912380 ↗
• MalfunctionFeb 19, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, IT NOTED THAT THE OCCLUDER CONFORMED INTO COBRA-LIKE DEFORMATION AND AFTER RETRIEVING THE OCCLUDER, IT WAS OBSERVED THAT THE FABRIC OF THE LA DISC WAS DEFECTIVE AND INCOMPLETELY ATTACHED TO METAL MESH. THE PROCEDURE WAS COMPLETED USING A NEW 18MM 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 24390248 ↗
• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335049 ↗
• MalfunctionJan 23, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER CONFORMED INTO A TIRE-LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. 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 CAME IN 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 24169066 ↗
• MalfunctionSep 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER TOOK FORM OF A COBRA DEFORMATION. 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. THE PROCEDURE WAS ABORTED. IT IS REPORTED THAT THE PHYSICIAN OPTED TO COMPLETE THE PROCEDURE SURGICALLY. THERE WAS NO ADVERSE CONSEQUENCES REPORTED AND THE PATIENT IS HEMODYNAMICALLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059848 ↗
• MalfunctionSep 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AS AN IMPLANT USING 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER TOOK FORM OF A COBRA DEFORMATION. IT IS 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 WERE NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REPLACED WITH A NEW 18MM AMPLATZER SEPTAL OCCLUDER TO COMPLETE THE PROCEDURE. IT IS NOTED THAT THERE WERE NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042947 ↗
• MalfunctionJun 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, WHILE PUSHING IT OUT OF THE SHEATH WHICH WAS ALREADY IN THE PATIENT, THE TYPICAL COBRA FORMATION WAS NOTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS INTERACTIONS WITH THE SUPERIOR AND POSTERIOR WALL OF THE HEART THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. 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 22330858 ↗
• MalfunctionJun 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. 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 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 22329451 ↗
• MalfunctionMay 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114188 ↗
• InjuryMay 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 18MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. THE IMPLANTATION PROCEDURE WAS UNEVENTFUL, AND POST-IMPLANTATION TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NO SIGNS OF COMPRESSION. ON (B)(6) 2025, THE PATIENT LOST CONCIOUSNOUSS IN PUBLIC AND WAS TRANSPORTED TO THE HOSPITAL. PERICARDIAL EFFUSION WAS OBSERVED THAT WAS LEADING TO CARDIAC TAMPONADE. THE PATIENT UNDERWENT EMERGENT SURGICAL INTERVENTION AS DEVICE EROSION WAS OBSERVED. THE DEVICE WAS EXPLANTED AND THE SEPTAL DEFECT WAS SURGICALLY REPAIRED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Syncope/Fainting; Unspecified Tissue Injury

  MAUDE report 22080818 ↗
• MalfunctionApr 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT BOTH DISCS OF THE OCCLUDER TOOK ON COBRA SHAPES. THE OCCLUDER WAS RE-LOADED AND RE-DEPLOYED BUT THE OCCLUDER DID NOT RETURN TO ITS ORIGINAL 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. 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 21875074 ↗
• InjuryMar 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEVICE WAS SIZED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND FLUOROSCOPY AT 16.4MM AND 16MM. A 24MM AMPLATZER SIZING BALLOON WAS INFLATED TO STOP THE FLOW. THE 18MM OCCLUDER WAS IMPLANTED. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED DURING RECOVERY, IN WHICH THE SEPTAL OCCLUDER WAS NOT VISIBLE. PLAIN XRAY WAS THEN PERFORMED, WHICH SHOWED THE OCCLUDER IN THE THORACIC AORTA. THE PATIENT WAS RETURNED TO THE CATH LAB FOR RETRIEVAL. ULTRASOUND GUIDANCE WAS USED FOR LEFT CFA ACCESS. A 12F SHEATH WAS PLACED AND THE SNARE WAS INTRODUCED INTO THE PATIENT. THE OCCLUDER WAS PULLED DOWN TO THE TIP OF THE SHEATH AND SUCCESSFULLY PULLED INTO THE SHEATH WITH SOME DIFFICULTY; THE OCCLUDER WAS REMOVED FROM THE PATIENT. TEE WAS REPEATED, WHICH SHOWED THAT THE PATIENT'S SEPTAL DEFECT NOW MEASURED 22MM. A NEW 22MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A NEW 9F AMPLATZER TREVISIO DELIVERY SYSTEM AFTER "MINNESOTA WIGGLE" WAS PERFORMED WITH NO MOVEMENT. POST-OP CT CONFIRMED THE DEVICE WAS IMPLANTED IN GOOD POSITION. THE PATIENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635989 ↗
• MalfunctionMar 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Advance; Patient Device Interaction Problem; Difficult to Fold, Unfold or Collapse; Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS NOT POSSIBLE TO PASS THROUGH THE 8F AND THEY CHANGED INTO A 9F. WHEN THE DEVICE WAS OPENING IN THE LEFT ATRIUM (LA), A COBRA DEFORMATION WAS NOTED. THE DEFORMED DEVICE HAS NOT BEEN RELEASED AND IT WAS TAKEN OUT, RESHAPED AND THEN RE-ADVANCED AGAIN. 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 SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS SOME DELAY BUT THERE WERE NO COMPLICATIONS. THE PATIENT WAS REPORTED DISCHARGED. ON 27 FEBRUARY 2025, THE PATIENT CAME FOR FOLLOW-UP AND A SMALL RESIDUAL LEFT-RIGHT SHUNT WAS NOTED. THE PHYSICIAN MENTIONED NO SHUNT WAS NOTED AT THE TIME OF DISCHARGE. THE SHUNT WAS ACCEPTABLE AT THIS STAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574546 ↗
• MalfunctionJan 13, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 18 MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THE DEVICE WAS NEVER DETACHED FROM THE DELIVERY CABLE, THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES, OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO CLINICALLY SIGNIFICANT PROCEDURE DELAY. THE PATIENT REMAINED HEMODYNAMIC STABLE THROUGHOUT PROCEDURE AND WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143801 ↗
• MalfunctionJan 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 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. THE OCCLUDER WAS REMOVED FROM THE PATIENT. 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 21092447 ↗
• InjurySep 26, 2024Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18 MM AMPLATZER SEPTAL OCCLUDER WAS PREMATURELY RELEASED FROM THE CABLE AND SUBSEQUENTLY EMBOLIZED TO THE LEFT ATRIUM THEN THE LEFT VENTRICLE AND COULD NOT BE SNARED OUT. A SURGICAL INTERVENTION WAS PERFORMED TO CLOSED THE DEFECT AND REMOVED THE DEVICE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315629 ↗
• MalfunctionAug 20, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. WHEN THE AMPLATZER SEPTAL OCCLUDER WAS EXPANDED IN THE ATRIAL SEPTAL, THE LEFT DISC BECAME A COBRA HEAD. IT WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) THAT IT COULD NOT BE EXPANDED IN THE PREDEFINED FORM. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WERE NOT BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH.THE DEVICE WAS REPLACED WITH A 17MM AMPLATZER SEPTAL OCCLUDER AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THE IMAGES OF THE DEFORMED OCCLUDER ARE NOT AVAILABLE. NO HEALTH IMPACT HAS BEEN REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005704 ↗
• InjuryMay 28, 2024Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. THE PATIENT HAD 2 ATRIAL SEPTAL DEFECTS (ASD). THE FIRST ASD WAS MEASURED AS 14MM AND THE SECOND DEFECT WAS 18MM. SIZING WAS DETERMINED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND A NON-ABBOTT SIZING BALLOON. THE PATIENT WAS IN SINUS RHYTHM DURING THE PROCEDURE. TEE WAS USED DURING THE PROCEDURE. THE 14MM OCCLUDER WAS IMPLANTED. AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON THE SECOND ASD. UPON IMPLANT, A LARGE RESIDUAL SHUNT WAS DETECTED, AND IT WAS OBSERVED THAT THE DEVICE MIGRATED. THE DEVICE WAS REMOVED FROM THE PATIENT VIA TRANSCATHETER SNARE AND REPLACED WITH A NEW 24MM AMPLATZER SEPTAL OCCLUDER. UPON IMPLANT, THE DEVICE MIGRATED DUE TO ONE OF THE EDGES OF THE DEVICES NOT TAKING TO THE DEFECT BECAUSE OF ITS SMALL SIZE. IT WAS NOTED DURING IMPLANT OF THE 24MM OCCLUDER, THE DEVICE MADE CONTACT WITH THE 14MM OCCLUDER, CAUSING THE 14MM OCCLUDER TO EMBOLIZE TO THE DESCENDING AORTA. THE 24MM OCCLUDER AND THE 14MM OCCLUDER WERE BOTH REMOVED FROM THE PATIENT VIA TRANSCATHETER SNARE. THE CAUSE OF THE EMBOLIZATION AND MIGRATIONS WAS BELIEVED TO HAVE BEEN DUE TO THE COMPLEX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404914 ↗
• MalfunctionMar 5, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT TAKING THE DESIRED SHAPE AND HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND THE DEVICE GOT RETRIEVED. 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 GOT ABORTED. 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 18841271 ↗
• MalfunctionFeb 15, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE LEFT DISC OF THE DEVICE TOOK ON A SNAKE SHAPE. ANOTHER ATTEMPT WAS MADE TO DEPLOY THE DEVICE. THE DISC MAINTAINED THE SNAKE SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 19MM 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715378 ↗