Amplatzer™ Septal Occluder (REF 9-ASD-015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00811806010120), received between May 13, 2019 and Sep 11, 2026 — classified as 8 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (18 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741478 ↗
• InjuryAug 14, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2024, a 15 mm Amplatzer Septal Occluder was implanted into patient. On (b)(6) 2026, it was discovered that the device was embolized into abdominal aorta which was known through Echocardiography

  Patient problems: Insufficient Information

  MAUDE report 50261413 ↗
• MalfunctionApr 21, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER CONFORMED INTO A TIRE SHAPE. THE PROCEDURE WAS COMPLETED USED BY 14MM 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 24934251 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER THE ECHOCARDIOGRAM (ECHO) WAS PERFORMED AND THE MEASUREMENT WITH AN 18-MM BALLOON WAS OBTAINED, THE SIZE OF THE PROSTHESIS WAS DEFINED AS 15MM. AFTER OPENING THE DEVICE, THE PHYSICIAN FOLLOWED THE STEP-BY-STEP ASSEMBLY PROCESS AS RECOMMENDED BY ABBOTT. AT THE MOMENT OF RELEASING THE FIRST DISC IN THE LEFT ATRIUM, THE PROSTHESIS EXHIBITED A COBRA SHAPE. SEVERAL ATTEMPTS WERE MADE TO CORRECT THE SHAPE, WITHOUT SUCCESS. SUBSEQUENTLY, THE ENTIRE SYSTEM WAS WITHDRAWN AND THE PROSTHESIS WAS IMMERSED IN WARM SALINE FOR THREE MINUTES. IT WAS THEN RELOADED, AND SEVERAL ADDITIONAL POSITIONING ATTEMPTS WERE PERFORMED, AGAIN WITHOUT SUCCESS. THE PROSTHESIS NO LONGER RESPONDED IN A NATURAL AND APPROPRIATE MANNER, MAKING IT NECESSARY TO OPEN A NEW PROSTHESIS. A NEW17MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469612 ↗
• MalfunctionFeb 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F NON-ABBOTT SHEATH. DURING THE DEPLOYMENT THE DEVICE, PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE AND HAD A COBRA DEFORMATION. 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 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 24401209 ↗
• MalfunctionFeb 9, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(60 2026, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHEN THE DEVICE WAS EXPANDING INSIDE THE BODY, IT WAS NOTED THAT THE OCCLUDER TOOK FORM OF A COBRA-LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NEW 25MM 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 24298503 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. MULTIPLE ATTEMPTS WERE MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE COBRA SHAPE REMAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 15MM AMPLATZER SEPTAL OCCLUDER. 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 23572592 ↗
• MalfunctionOct 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS OBSERVED TO DEFORM INTO A NON-CONFORMING SHAPE, RESEMBLING A COBRA CONFIGURATION. THE DEFORMED DEVICE WAS NOT RELEASED INSIDE THE PATIENT; IT REMAINED ATTACHED TO THE DELIVERY CABLE AND WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT 16MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT¿S ANATOMY WAS NOTED TO BE COMPLEX, WITH A SMALL LEFT ATRIUM, REQUIRING MULTIPLE MANIPULATIONS AND RECAPTURES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352789 ↗
• InjuryOct 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 15MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE PATIENT REQUIRED EMERGENCY HOSPITALIZATION FOR ENDOCARDITIS. THE PATIENT IS STILL IN COMA, IN RESUSCITATION IN CRITICAL STAGE. THE OCCLUDER IS STILL IMPLANTED IN THE PATIENT. THE PATIENT IS STILL HOSPITALIZED AND REPORTED STABLE.

  Patient problems: Coma; Endocarditis; Movement Disorder; Stroke/CVA

  MAUDE report 23337192 ↗
• InjurySep 26, 2025Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED ON (B)(6) 2025 A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE OCCLUDER WAS IMPLANTED. ON (B)(6) 2025 A SMALL AORTA TO LEFT ATRIUM SHUNT WAS OBSERVED. AN AORTOGRAPHY CONFIRMED A 0.5MM SHUNT CAUSED BY EROSION OF THE AORTA WITH THE LEFT ATRIAL DISC OF THE OCCLUDER. ON (B)(6) 2025 THE OCCLUDER WAS SURGICALLY EXPLANTED AND THE ASD WAS SURGICALLY CLOSED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Erosion

  MAUDE report 23160740 ↗
• MalfunctionSep 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F NON-ABBOTT DELIVERY SHEATH TO TREAT AN ATRIAL SEPTAL DEFECT. DURING DEPLOYMENT, 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 SHEATH. 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 22953271 ↗
• InjuryJul 17, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. THE DIMENSIONS OF THE DEFECT WERE 12-17. THE SIZING OF THE DEVICE WAS DETERMINED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). DURING IMPLANT, ECHOCARDIOGRAM WAS UTILIZED AND THE DEVICE WAS RELEASED AFTER SUCCESSFUL STABILITY CHECK. NO LEAK WAS OBSERVED. HOWEVER, FLUOROSCOPY SHOWED THAT THE DEVICE SHIFTED IN POSITION AND THEN EMBOLIZED TO THE ASCENDING AORTA. IT WAS RETRIEVED SUCCESSFULLY VIA PERCUTANEOUS REMOVAL. THE USER BELIEVED THE CAUSE OF DEVICE EMBOLIZATION WAS "WEIRD DEFECT AND UNDERSIZED." THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534570 ↗
• MalfunctionJun 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT 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 AND WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SHEATH. 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 22308699 ↗
• MalfunctionApr 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER MADE CONTACT WITH THE SEPTAL WALL WHILE DEPLOYING. THE OCCLUDER WAS RE-LOADED SEVERAL TIMES BUT CONTINUED TO FORM A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 15MM AMPLATZER SEPTAL OCCLUDER. THERE WAS NO DAMAGE TO THE SEPTAL WALL. 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 21807392 ↗
• MalfunctionJan 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F NON-ABBOTT DELIVERY SYSTEM. DURING DEPLOYMENT THE DEVICE, PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE AND HAD A COBRA DEFORMATION SO 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 21240967 ↗
• InjuryDec 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A MITRACLIP PROCEDURE AND THE TRANSSEPTAL PUNCTURE (TSP) HAD A BIODIRECTIONAL SHUNT. THE TSP WAS POSTERIOR AND MID; THE DIMENSIONS WERE 13MM X 10MM AND WAS MEASURED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THEREFORE, A 15MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED INTO THE TSP WITH NO REPORTED COMPLICATIONS. STABILITY CHECK WAS PERFORMED AND NO LEAK WAS OBSERVED AROUND THE LOBE OF THE OCCLUDER. ON (B)(6) 2024, THE SEPTAL OCCLUDER HAD DISLODGED COMPLETELY FROM THE TSP AND ENDED UP IN THE LEFT ATRIUM. THE DISLODGED OCCLUDER DID NOT CAUSE ANY BLOCKAGE OF BLOOD FLOW AND WAS PERCUTANEOUSLY REMOVED FROM THE PATIENT. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN ALLEGED THAT THE CAUSE OF DISLODGEMENT WAS DUE TO NOT SIZING CORRECTLY. A NEW, LARGER SIZED AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021690 ↗
• InjurySep 13, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON 21 AUG. 2024, A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHEN DEPLOYING THE DEVICE, THE LEFT DISC DIDN'T EXPAND AS USUAL. DEVICE WAS PARTIALLY RECAPTURE WAS PERFORMED TWICE, BUT WAS DIFFICULT. THEREFORE THE USER EXPANDED BOTH DISCS (LEFT AND RIGHT DISC) IN THE RIGHT ATRIUM (RA), AND AN ATTEMPT WAS MADE TO PUSH OUT THE LEFT DISC. THE DEVICE WAS THEN FOUND TO HAVE DISLODGED FROM THE DELIVERY CABLE AND DROPPED INTO THE RA. A PERCUTANEOUS SNARE WAS USED TO RETRIEVE THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO HEALTH IMPACT RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212841 ↗
• MalfunctionJul 31, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEVICE IMPLANT, ON THE FIRST DEPLOYMENT, THE LEFT DISC WAS PERPENDICULAR TO THE SEPTUM AND CROSSED INTO THE RIGHT ATRIUM; IT WAS RECAPTURED AND CROSSED AGAIN. DURING THE SECOND DEPLOYMENT AND POSITIONING IN THE LEFT ATRIUM, COBRA DEFORMATION WAS OBSERVED. 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 OCCLUDER WAS REMOVED FROM THE PATIENT AND CHECKED ON THE SURGERY TABLE IN WARM WATER, BUT THE DEFORMATION PERSISTED. A NEW 14MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19876513 ↗
• MalfunctionMay 15, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED ABBOTT DELIVERY SYSTEM. DURING IMPLANTATION, WHILE DEPLOYING THE LEFT DISC, COBRA DEFORMATION WAS OBSERVED AND THE DEVICE WAS NOT IMPLANTED. THE DEVICE WAS RECAPTURED TWICE AND THEN REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. A NEW 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324984 ↗
• MalfunctionFeb 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, "HEADACHES IN CHILDREN AFTER TRANSCATHETER DEVICE CLOSURE OF ATRIAL SEPTAL DEFECTS: A SINGLE CENTRE EXPERIENCE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 5-YEAR-OLD, 16.5 KG, FEMALE PATIENT WITH A FENESTRATED ATRIAL SEPTAL DEFECT. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 15MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. A SMALL RESIDUAL SHUNT WAS NOTED DURING PROCEDURE. IT WAS THEN REPORTED SHORTLY AFTER PROCEDURE, THE PATIENT DEVELOPED DIZZINESS AND FATIGUE. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, HOWEVER, RESULTS WERE NORMAL AND NON-PATHOLOGIC. THE PATIENT LATER DESCRIBED EXPERIENCING HEADACHES, GRADUALLY IMPROVING BUT STILL DOCUMENTED SEVERAL YEARS AFTER THE PROCEDURE. THE ARTICLE CONCLUDED THAT THE STUDY SUGGESTED A MINIMAL ESTIMATE OF 15% AS THE INCIDENCE OF HEADACHE IN CHILDREN WHO UNDERGO TDC. THIS ESTIMATE CAN INFORM COUNSELING PRIOR TO TDC. DETERMINATION OF THE TRUE INCIDENCE WILL REQUIRE FOCUSED PROSPECTIVE DATA COLLECTION. [(B)(6)].

  Patient problems: Fatigue; Headache; Movement Disorder

  MAUDE report 18748644 ↗
• MalfunctionJan 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR IMPLANT ON (B)(6) 2023 USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT IT WAS OBSERVED THAT THE DEVICE WAS THE INCORRECT SIZE. THE DEVICE WAS REPLACED WITH A NEW 12MM AMPLATZER SEPTAL OCCLUDER. THE DEVICE WAS OBSERVED BE A MIS-SIZING AS WELL. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED. DURING IMPLANT, THE LEFT DISC OF THE DEVICE TOOK ON A COBRA SHAPE. AN ATTEMPT WAS MADE TO RE-INSERT THE DEVICE INTO THE SHEATH AND DEPLOY. THE DEVICE TOOK ON A COBRA SHAPE AGAIN. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 17MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURES. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499416 ↗
• MalfunctionJan 8, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 15MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING AN 8F AMPLATZER TORQVUE. DURING IMPLANT THE DEVICE WAS OBSERVED TO BE UNABLE TO BE FULLY OPENED. THE DEVICE WAS REPLACED WITH A NEW 14MM 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 18471978 ↗
• MalfunctionNov 8, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 18 OCTOBER 2023, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A 14MM ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WOULD NOT FIT THROUGH THE HUB OF THE DELIVERY SYSTEM. THE DEVICE WAS THEN REMOVED FROM THE PATIENT TABLE AND CHECKED OVER ON THE BACK TABLE. UPON RE-PREPPING, THE DEVICE THEN DEFORMED WHILE BEING PULLED INTO THE 7FR LOADER. THE FIRST 15MM ASO NEVER WENT IN THE BODY. 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 15MM AMPLATZER SEPTAL OCCLUDER AND 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WERE CHOSEN. WHEN THE SECOND 15MM AMPLATZER SEPTAL OCCLUDER WAS ADVANCED THROUGH THE SHEATH TO THE LEFT ATRIUM, AFTER A FEW ATTEMPTED DEPLOYMENTS IN DIFFICULT ANATOMY, THE DEVICE DEFORMED INTO A COBRA HEAD IN THE BODY. THE DEVICE WAS REMOVED SUCCESSFULLY THROUGH THE SHEATH, AND WAS NEVER RELEASED FROM THE CABLE. A NEW THIRD 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN. WHEN THE THIRD DEVICE POSITIONED ON THE ATRIAL SEPTUM AND DETERMINED TO BE TOO SMALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093723 ↗
• MalfunctionSep 24, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 15MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR IMPLANT. UPON DEPLOYMENT THE DEVICE DEFORMED INTO A COBRA SHAPE. IT WAS RETRACTED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE AND REDEPLOYED OUTSIDE THE PATIENT WITHOUT DEFORMATION. THERE WAS AN ATTEMPT AT A SECOND DEPLOYMENT INSIDE THE PATIENT BUT THE DEFORMATION APPEARED AGAIN. THERE WAS NO IN INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REPLACED WITH A 16MM AMPLATZER SEPTAL OCCLUDER AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE WAS DELAY IN THE PROCEDURE BUT THE PATIENT REMAIN HEMODYNAMICALLY STABLE, THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478463 ↗
• MalfunctionJun 27, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 23 MAY 2022, A 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE DEPLOYED AS A COBRA DEFORMATION. THERE WAS AN INTERACTION WITH THE ATRIAL SEPTUM DURING DEPLOYMENT. AFTER A SERIES OF ATTEMPTS, THE DECISION WAS MADE TO REPLACE THE DEVICE. A 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED INSTEAD. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14834261 ↗