Amplatzer™ Septal Occluder (REF 9-ASD-014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00811806010113), received between Nov 8, 2018 and Sep 18, 2026 — classified as 28 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 14mm Amplatzer Septal Occcluder was chosen for implant using an unknown delivery system. During the procedure, it was noted that the device conformed into cobra shape. It was also noted that the delivery sheath was found to be leaking. 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 50819767 ↗
• InjurySep 18, 2026Migration or Expulsion of Device; Off-Label Use

  It was reported that on (b)(6) 2026, a 14mm Amplatzer Septal Occluder was chosen for implant using an unknown delivery system. The Amplatzer Septal occluder was implanted following a mitral clip procedure in Mitral Valve Leaflet. Transesophageal echocardiography (TEE) was used during the procedure. The implanter believed the cause of the subsequent device embolization was undersizing and the location of the device. Following implantation, the device completely dislodged from the intended implant site and embolized. The embolization was not identified intraprocedurally and became known as a post-procedural event. Transthoracic echocardiography (TTE) identified the device embolization. To address the embolized device, surgical retrieval was performed. It was reported that the patient had experienced a MitraClip-related leaflet tear and the ASD device had been used on the leaflet. The patient also had other issues related to the MitraClip procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819142 ↗
• MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, 14mm Amplatzer Septal Occluder was chosen for implant using an unknown delivery system. During the procedure, it was noted that the device conformed to cobra shape once deployed in the left atrium. 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 physician doctor recaptured the device to check in water again; it took the same aspect. A new 14mm Amplatzer Septal Occluder was used as a replacement device to complete the procedure. 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 50801441 ↗
• MalfunctionSep 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741473 ↗
• InjuryJun 11, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 14mm Amplatzer Septal Occluder was implanted using a 8F Amplatzer Trevisio delivery system. The defect was reported to have been sized at 18 mm using a sizing balloon (SB), with device sizing determined based on fluoroscopy and transesophageal echocardiography (TOE) measurements; it was additionally noted that a 12 mm ASD was initially missized prior to implantation of the 14 mm device. The procedure was performed under TOE and fluoroscopic guidance, and a stability check was reportedly performed. The patient subsequently presented for a routine follow-up on (b)(6) 2026, at which time it was identified that the device had embolized. It was clarified that the device had completely dislodged from the implant site, with suspected missizing considered a potential contributing factor. This finding was confirmed on a routine chest X-ray, which demonstrated that the device had migrated to a position just below the renal arteries. It was further reported that the embolized device did not result in partial or complete obstruction of blood flow. It was further reported that a retrieval procedure was planned, with the patient scheduled to undergo device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466312 ↗
• InjuryApr 9, 2026Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2026 A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE ASD MEASURED 14MM. 3D ECHOCARDIOGRAM AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE USED FOR DEVICE SIZING. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED DURING THE PROCEDURE. A STABILITY CHECK WAS PERFORMED. UPON RELEASE FROM THE DELIVERY CABLE, THE OCCLUDER EMBOLIZED TO THE AORTA. THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. THE USER BELIEVED THE PATIENT'S EXTREMELY FLOPPY SEPTUM PRIMUM CAUSED THE DEVICE TO EMBOLIZE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835293 ↗
• InjuryMar 31, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 14MM AMPLATZER SEPTAL OCCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE PATIENT HAD A RECENT MYOCARDIAL INFARCTION AND SUSTAINED PERFORATION OF THE LEFT VENTRICULAR WALL AND VENTRICULAR SEPTUM DURING BYPASS SURGERY. THE AFFECTED AREAS WERE PATCHED INTRAOPERATIVELY; HOWEVER, A RESIDUAL SHUNT REMAINED. AN INITIAL ATTEMPT WAS MADE TO CLOSE THE SHUNT USING AN 8MM AMPLATZER MUSCULAR VSD DEVICE, BUT RESIDUAL SHUNTING PERSISTED. THE DEFECT WAS THEN RESIZED, AND A 10MM AMPLATZER MUSCULAR VSD DEVICE WAS DEPLOYED, AFTER WHICH THE SHUNT WAS STILL NOTED. AS A RESULT, A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED, AND THE SURGEON AND INTERVENTIONAL CARDIOLOGIST REVIEWED THE CASE AND AGREED TO RELEASE THE DEVICE. FOLLOWING THE PROCEDURE, THE DEVICE WAS REPORTED TO HAVE EMBOLIZED AND WAS RETRIEVED FROM THE PULMONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749730 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720365 ↗
• MalfunctionFeb 19, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390218 ↗
• MalfunctionDec 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM 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 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 ABORTED. 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 23784456 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER THE DEVICE WAS DEPLOYED IN THE LEFT ATRIUM, THE OCCLUDER DEFORMED INTO A COBRA-LIKE SHAPE. THE DEFORMED OCCLUDER WAS RETRIEVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. NO CONTACT OCCURRED WITH INTRACARDIAC TISSUE DURING DEPLOYMENT. NO BENDS OR KINKS WERE OBSERVED IN THE DELIVERY SHEATH. THE PROCEDURE WAS ABORTED ON THAT DAY AND ANOTHER ATTEMPT WAS MADE ON ANOTHER DATE AND COMPLETED WITHOUT FURTHER ISSUE. 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 23572913 ↗
• MalfunctionSep 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F NON-ABBOTT SHEATH. DURING THE DEPLOYMENT THE DEVICE, PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE, THAT¿S WHY THEY HAVE TO RETRIEVE THE DEVICE BACK. 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 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 22994157 ↗
• InjuryJun 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TORQVUE 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 13MM 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 22359647 ↗
• MalfunctionJun 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE SECOND DISC WAS UNABLE TO OPEN THROUGH THE FIRST DEPLOYMENT AND HAD A BULBOUS DEFORMATION. THE FIRST DISC OPENED IN THE LEFT ATRIUM (LA); HOWEVER, THE PHYSICIAN WAS UNABLE TO DEPLOY THE SECOND DISC IN THE RIGHT ATRIUM (RA). IT WAS NOT USABLE DESPITE WAITING FOR IT TO REGAIN ITS SUPPOSED 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. A NEW 14MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS USED AND THE PROCEDURE WENT ON SMOOTHLY WITH NO ADVERSE OR DELAYED EFFECT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213325 ↗
• InjuryMay 22, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073722 ↗
• MalfunctionFeb 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Advance

  IT WAS REPORTED THAT A 14 AMPLATZER SEPTAL OCCLUDER FOR IMPLANT ON (B)(6) 2025 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THE CABLE FROM THE CONNECTION OF THE LOADER TO THE DELIVERY SHEATH. DURING IMPLANT THE LEFT ATRIAL DISC OF THE OCCLUDER TOOK ON A COBRA SHAPE. AN ATTEMPT WAS MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE COBRA SHAPE REMAINED. THE OCCLUDER WAS WIGGLED BUT DID NOT RETURN TO ITS ORIGINAL SHAPE. AFTER 10 MINUTES THE DECISION WAS MADE TO REMOVE THE OCCLUDER FROM THE PATIENT AND REPLACED WITH A NEW NON-ABBOTT DEVICE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT 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 21446695 ↗
• MalfunctionDec 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6)2024 USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF THE DEVICE TOOK ON A BULGING SHAPE IN THE LEFT ATRIUM. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 14MM AMPLATZER SEPTAL OCCLUDER. THERE WAS SOME INTERACTION 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 DURING 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 20869012 ↗
• InjuryNov 19, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 25 OCTOBER 2024, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING AN UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE BALLOON SIZED SUSPECTED SINGLE DEFECT ASD BUT BALLOON SIZING AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SHOWED THAT THERE WAS A SECOND DEFECT NEAR THE INITIAL DEFECT. THEY DECIDED TO BALLOON THE FIRST DEFECT, PLACE THE DEVICE AND THEN BALLOON SIZE SECOND DEFECT. THE FIRST DEFECT WAS BALLOON SIZED TO 12-13MM AND THE 14MM AMPLATZER SEPTAL OCCLUDER WAS PLACED AND STABILITY TEST WAS PERFORMED. SUBSEQUENTLY THEY BALLOONED THE SECOND DEFECT AND SHOWED 10MM. WHEN THE DELIVERY SYSTEM WAS PLACED ACROSS THE SECOND DEFECT, THE 14MM DEVICE WAS EMBOLIZED TO DISTAL AORTA. THE PHYSICIAN MENTIONED THERE WAS A PARTIAL OBSTRUCTION OF THE BLOOD FLOW. THE PHYSICIAN MENTIONED THE CAUSE OF EMBOLIZATION WAS THE ISTHMUS OF TISSUE BETWEEN THE TWO DEFECTS POPPED/TORE CREATING ONE LARGER DEFECT. THE 14MM DEVICE WAS SNARED AND REMOVED WITHOUT DIFFICULTY. THE SINGLE DEFECT WAS BALLOON SIZED TO 22MM AND A NEW 24MM AMPLATZER SEPTAL OCCLUDER WAS PLACED WITHOUT ANY ISSUES. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20726373 ↗
• MalfunctionOct 31, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 13MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO KINKS AND ANGULATIONS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE 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 20579112 ↗
• MalfunctionSep 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE DEVICE DEPLOYED AS A COBRA DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND EXCHANGED WITH A 12MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162930 ↗
• MalfunctionMay 24, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 8F NON-ABBOTT DELIVERY SHEATH. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, IT DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS RETRACTED AND REMOVED FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION IN THE DELIVERY SYSTEM. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397248 ↗
• InjuryMay 23, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  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 COMPLEXI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385761 ↗
• MalfunctionMar 26, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT, USING 09F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE WAS OBSERVED TO DEFORM TO A COBRA-LIKE SHAPE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED, AND A REPLACEMENT 13MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. 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 18978026 ↗
• InjuryFeb 5, 2024Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  THE ARTICLE, "EARLY INFECTIVE ENDOCARDITIS ASSOCIATED WITH AN AMPLATZER ATRIAL SEPTAL OCCLUDER DEVICE IN A 14-YEAR-OLD MALE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 14-YEAR-OLD MALE WITH AN ATRIAL SEPTAL DEFECT (ASD). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14MM AMPLATZER ATRIAL SEPTAL OCCLUDER WAS IMPLANTED. THE PATIENT UNDERWENT AN ADJUSTMENT OF HIS DENTAL BRACE ONE WEEK AFTER ASD CLOSURE. FOUR WEEKS FOLLOWING ASD CLOSURE, THE PATIENT PRESENTED WITH FEVER, ALTERED MENTAL STATUS, AND RASH. PHYSICAL EXAMINATION REVEALED MULTIPLE ERYTHEMATOUS, NON-TENDER, PINPOINT-MACULAR LESIONS ON HIS PALMS AND SOLES, CONSISTENT WITH JANEWAY LESIONS. TWO CONSECUTIVE TRANSTHORACIC ECHOCARDIOGRAMS (TTE) WERE NEGATIVE FOR VEGETATIONS. MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN SHOWED MULTIPLE SMALL EMBOLIC INFARCTS AND OPHTHALMOLOGIC EVALUATION REVEALED BILATERAL INTRA-RETINAL HEMORRHAGES. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DEMONSTRATED AN ECHOGENIC MASS MEASURING 10 × 6 MM ATTACHED TO THE LEFT ATRIAL DISC OF THE ASD DEVICE WITHOUT ANY RESIDUAL SHUNT. SUBSEQUENTLY, BLOOD CULTURE GREW STAPHYLOCOCCUS AUREUS. A DECISION WAS MADE TO SURGICALLY REMOVE THE 14MM AMPLATZER OCCLUDER A

  Patient problems: Cognitive Changes; Embolism/Embolus; Endocarditis; Fever; Rash; Thrombosis/Thrombus

  MAUDE report 18646679 ↗
• MalfunctionSep 15, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN SIZE 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 14MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. PATIENT HAD NO REPORTED COMPLICATIONS. PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756182 ↗