Amplatzer™ 9-ASD-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05415067019295), received between Mar 30, 2022 and Apr 25, 2023 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 24MM AMPLATZER SEPTAL OCCLUDER (LOT 8406508) WAS CHOSEN FOR IMPLANTATION INTO AN ATRIAL SEPTAL DEFECT (ASD) UTILIZING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (LOT 8234812). DURING IMPLANTATION, A COBRA SHAPED DEFORMATION WAS OBSERVED IN THE OCCLUDER. THE DEVICE WAS RETRACTED, REALIGNED, AND FLUSHED BEFORE RE-TRYING IMPLANTATION, BUT THE COBRA DEFORMATION OCCURRED AGAIN. THE DEVICE WAS REMOVED AND A REPLACEMENT 22MM AMPLATZER SEPTAL OCCLUDER (LOT 8393118) WAS ATTEMPTED TO BE IMPLANTED UTILIZING A NEW 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (LOT 8337467). DURING IMPLANTATION, THIS DEVICE ALSO HAD A COBRA SHAPED DEFORMATION. IMPLANTATION WAS REATTEMPTED, BUT THE ISSUE PERSISTED. A THIRD 18MM AMPLATZER SEPTAL OCCLUDER (LOT 8293150) WAS THEN SUCCESSFULLY IMPLANTED UTILIZING A THIRD 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (LOT 8337467). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO INTERACTION WITH ANY CARDIAC STRUCTURES DURING THE DEPLOYMENT OF THE FIRST TWO DEVICES. NO ANGULATION OR KINKING WAS NOTED IN ANY OF THE DELIVERY SYSTEMS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811789 ↗
• MalfunctionApr 14, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE LEFT DISC OF THE DEVICE DEFORMED AND APPEARED TO BE SHAPED LIKE A BALLOON. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. 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 DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 20MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743075 ↗
• MalfunctionApr 13, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR ATRIAL SEPTAL DEFECT (ASD) IMPLANTATION UTILIZING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING IMPLANTATION, ONE OF THE DISCS ON THE OCCLUDER HAD A DEFORMED BULBOUS SHAPE. THE DEVICE WAS NOT DEPLOYED AND WAS REMOVED FROM THE PATIENT WITHOUT ISSUES. THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738933 ↗
• MalfunctionMar 20, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN UNKNOWN DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE EXHIBITED A DOUBLE COBRA HEAD DEFORMATION. AFTER MULTIPLE ATTEMPTS TO CORRECT THE CONFIGURATION, A DECISION WAS MADE TO ABORT THE PROCEDURE AND REMOVE THE DEFORMED DEVICE. IT WAS REPORTED THE DEVICE WAS NOT REMOVED FROM THE DELIVERY CABLE. THERE WAS NO REPORT OF INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THERE WAS NO REPLACEMENT DEVICE REPORTED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575016 ↗
• MalfunctionMar 16, 2023Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE OPERATOR EXPERIENCED DIFFICULTY PULLING THE DEVICE INTO THE LOADER OF THE DELIVERY SYSTEM. THE OPERATOR WAS ABLE TO LOAD THE DEVICE BUT DURING DEPLOYMENT THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO REPLACE BOTH THE DEVICE AND THE DELIVERY SYSTEM. A REPLACEMENT 22MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN THE PATIENT WITH A NEW 10FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WITH NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES . THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK NOTICED WITH THE ORIGINAL DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS STABLE. IT WAS REPORTED THE PHYSICIAN BELIEVES THE CAUSE OF DEFORMATION WAS DUE TO DIFFICULTY IN LOADING THE DEVICE INTO THE DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554159 ↗
• MalfunctionMar 2, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 10FR AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. AFTER MULTIPLE ATTEMPTS TO CORRECT THE CONFIGURATION, A DECISION WAS MADE TO REPLACE THE DEVICE WITH AN 18MM AMPLATZER SEPTAL OCCLUDER. THE REPLACEMENT DEVICE WAS IMPLANTED IN THE PATIENT WITH NO REPORTED ADVERSE CONSEQUENCES. IT WAS REPORTED THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND THERE WAS NO ANGULATION/KINK WITH THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474964 ↗
• InjuryMar 2, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A DEFECT WITH DIMENSIONS OF 19.2 MM ON ANGIOGRAM. POST PROCEDURE THE NEXT DAY, ON (B)(6) 2023, IT WAS REPORTED THAT THE DEVICE EMBOLIZED TO THE AORTA. ON REVIEW BY THE CLINICIANS, IT WAS REPORTED THAT THE DEVICE HAD BEEN INADVERTENTLY ATTACHED TO THE EUSTACHIAN VALVE INSTEAD OF THE SEPTUM. PER THE PHYSICIAN, THE ANATOMY OF THE PATIENT HAD BEEN MISINTERPRETED. THE OCCLUDER WAS RETRIEVED VIA CATHETER AND GOOSENECK SNARE AND REMOVED FROM THE PATIENT. NO DEVICE WAS ULTIMATELY IMPLANTED. ON (B)(6) 2023 THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474302 ↗
• MalfunctionFeb 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTING USING A 10F NON-ABBOTT DELIVERY SHEATH. THE OCCLUDER WAS SIZED VIA ECHO. IT WAS NOTED DURING PROCEDURE VIA FLUOROSCOPY THAT THE OCCLUDER EXHIBITED A COBRA DEFORMATION WHEN BEING DEPLOYED. THE 22MM AMPLATZER SEPTAL OCCLUDER WAS NEVER RELEASED FROM THE CABLE, THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES, AND NO KINK WAS OBSERVED WITH THE DELIVERY SHEATH. THE OCCLUDER AND THE 10F NON-ABBOTT DELIVERY SHEATH WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358085 ↗
• MalfunctionJan 9, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING AN UNKNOWN NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, DURING IMPLANTATION, IT WAS NOTED THAT THE DEVICE WAS DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT IS REPORTED TO BE DISCHARGED. 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 16125226 ↗
• MalfunctionDec 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(4) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WERE NO KINKS OR ANGULATION NOTICED IN THE DELIVERY SYSTEM. DURING THE FIRST ATTEMPT TO DEPLOY THE DEVICE IN THE PATIENT BODY, IT DEPLOYED IN A COBRA DEFORMATION SHAPE. THE DEVICE WAS PLACED IN HOT SALINE BUT DID NOT REVERT BACK TO ITS USUAL SHAPE. A 20MM AMPLATZER SEPTAL OCCLUDER (8392162) WAS THEN SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED 24 HOURS AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960974 ↗
• MalfunctionNov 28, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN SIZE NON-ABBOTT DELIVERY SYSTEM. THE DEFECT WAS SIZED USING TRANSTHORACIC ECHOCARDIOGRAM (TTE) WITH DIMENSION OF 18-19MM. AFTER DEPLOYMENT THE HEALTHCARE PROFESSIONAL CHECKED THE DEVICE VIA FLUOROSCOPY AND CONFIRMED IT WAS SITTING WELL. WHILE OBSERVING VIA ECHOCARDIOGRAM IT WAS FOUND THAT THE DEVICE HAD MIGRATED. THE DEVICE SHIFTED IN POSITION WITHIN THE INTENDED IMPLANT SITE TOWARDS THE LEFT ATRIUM. THE PATIENT WAS SENT FOR SURGERY AND THE DEVICE WAS REMOVED. THE CAUSE OF THE MIGRATION WAS UNKNOWN. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO COMPLICATION NOTED DURING THE IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874276 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "RESCUE ATRIAL SEPTAL DEFECT CLOSURE WITH THE NEW GORE® CARDIOFORM ATRIAL SEPTAL DEFECT OCCLUDER" WAS REVIEWED. IT WAS REPORTED THAT ON AN UNKNOWN DATE A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION. PRIOR TO THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A RIGHT BUNDLE BRANCH BLOCK BY ELECTROCARDIOGRAM (EKG). A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THAT THE DEFECT WAS 14MM. THE DEVICE WAS SUCCESSFULLY IMPLANTED. 24 HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A COMPLETE HEART BLOCK. THEY ADMINISTERED METHYLPREDNISOLONE THERAPY, AND THEN THE DEVICE WAS REMOVED USING A GOOSE NECK CATHETER. THE PATIENT RECOVERED AND HAD NORMALIZED RHYTHM. A FEW MONTHS LATER, A SECOND ATTEMPT AT SIZING WAS DONE, AND IT WAS FOUND THAT THE DEFECT WAS 23-24MM. A 44MM ATRIAL SEPTAL DEFECT (ASD) CLOSURE DEVICE WAS SELECTED AND SUCCESSFULLY IMPLANTED. AT THE SIX MONTH FOLLOW UP, THE PATIENT WAS REPORTED TO BE STABLE AND NORMAL SINUS RHYTHM. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRIMARY AUTHOR OF THE ARTICLE IS ALESSANDRA PIZZUTO, MD, DEPARTMENT OF PEDIATRIC CARDIOLOGY AND GUCH UNIT, HEART HOSPITAL ¿G. PASQUINUCCI¿, NATIONAL RESEARCH COUNCIL TUSCANY REGION ¿G. MONAST

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 15840669 ↗
• MalfunctionNov 19, 2022Difficult 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 ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 10 F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS PRESENTED IN A BULBOUS DEFORMATION. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. IT WAS NOTE THAT THE 22MM AMPLATZER SEPTAL OCCLUDER WAS ULTIMATELY IMPLANTED. THE PATIENT STATUS WAS NOTED AS STABLE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830848 ↗
• MalfunctionOct 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM(ITV). COBRA DEFORMATION WAS NOTED WHILE DEPLOYING THE OCCLUDER. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM IT IS UNKNOWN IF THERE WAS A REPLACEMENT DEVICE IMPLANTED. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15669542 ↗
• MalfunctionOct 19, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS DEFORMED INTO A COBRA SHAPE. IT WAS THEN REMOVED FROM THE PATIENT. THERE WAS NO KINKS OR ANGULATION NOTED IN THE DELIVERY SYSTEM, AND NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635496 ↗
• MalfunctionOct 7, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE, AND HENCE WAS RETRIEVE FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566817 ↗
• MalfunctionSep 14, 2022Difficult 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 ON 22 AUGUST 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE LEFT ATRIAL DISC OF THE OCCLUDER WAS DEFORMED WHEN BEING DEPLOYED. SEVERAL ATTEMPTS WERE MADE TO PARTIALLY RECAPTURE THE OCCLUDER AND REDEPLOY IT, BUT THE DEFORMATION PERSISTED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 22MM AMPLATZER SEPTAL OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM HAD BEEN USED AT THE TIME THE DEFORMED 22MM AMPLATZER SEPTAL OCCLUDER WAS NOTED. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO KINK OR ANGULATION NOTED IN THE DELIVERY SYSTEM. THERE WERE ONLY 3 PARTIAL RECAPTURES OF THE DEFORMED OCCLUDER MADE. THE COBRA DEFORMATION OF THE AMPLATZER SEPTAL OCCLUDER WAS CONFIRMED/VISUALIZED WHILE INSIDE THE PATIENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM AND ANGIOGRAM EXAMINATION. IT WAS NOTED THAT THE SAME 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS USED TO IMPLANT THE SECOND 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420452 ↗
• MalfunctionJun 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR A PATIENT WITH A SEPTUM SECUNDUM ATRIAL SEPTAL DEFECT ON (B)(6) 2022. THE DEFECT WAS SIZED USING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) USING A COMPLAINT UNKNOWN SIZING BALLOON AT 20-21MM, THEREFORE A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED USING A AMPLATZER TREVISIO DELIVERY SYSTEM. THE DELIVERY SHEATH AND DEVICE WERE PREPARED AS PER INSTRUCTION FOR USE (IFU) WITHOUT ISSUE. THE DELIVERY SHEATH SHEATH WAS PLACED IN THE LEFT ATRIUM (LA). THE DEVICE WAS BROUGHT UP THE SHEATH WITHOUT ISSUE. AS THE LEFT DISC WAS UNSHEATHED, IT FORMED A COBRA HEAD DEFORMATION. THE DEVICE WAS FULLY UNSHEATHED IN THE LA, BUT THE COBRA HEAD DEFORMATION ON THE DISC REMAINED. THE DEVICE WAS FULLY RECAPTURED INTO THE SHEATH IN THE LA. A SECOND DEPLOYMENT WAS ATTEMPTED, BUT DEFORMATION REMAINED ON THE LEFT DISC. THE DEVICE WAS FULLY RECAPTURED A SECOND TIME AND REMOVED FROM THE PATIENT WITHOUT ISSUE PRIOR TO RELEASE FROM THE DELIVERY CABLE. A SECOND 22MM AMPLATZER SEPTAL OCCLUDER WAS PREPARED AS PER IFU AND IMPLANTED SUCCESSFULLY WITHOUT ISSUE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO INTERACTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692385 ↗
• MalfunctionMay 13, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS DEPLOYED AND A COBRA DEFORMATION WAS OBSERVED. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS RECAPTURED AND REMOVED PRIOR TO RELEASE. THERE WAS NO REPLACEMENT DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14391324 ↗
• MalfunctionApr 18, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 22 MM AMPLATZER ATRIAL SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022. THE DEVICE WAS PREPARED IN ACCORDANCE WITH THE PROCEDURE. THE OCCLUDER PRESENTED WITH A COBRA SHAPED DEFORMATION WHEN THE DISC WAS OPENED IN THE LEFT ATRIUM. THE DEVICE WAS REMOVED, LOADED AGAIN, BUT THE SAME EVENT OCCURRED. THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE AND EXCHANGED WITH A NEW, 24MM ATRIAL SEPTAL OCCLUDER, THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134531 ↗
• MalfunctionApr 5, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WERE NO ISSUES DURING DEVICE PREPARATION. DURING DEVICE DEPLOYMENT, THE DEVICE APPEARED AS A COBRA SHAPE WITH THE PHYSICIAN DEPLOYED THE LEFT DISC. THEN, THE LEFT DISC FLATTENED BUT NOT COMPLETELY. THE RIGHT DISC ALSO TOOK THE SAME SHAPE. THE DEVICE WAS REPLACED WITH ANOTHER 22MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ADVERSE EVENTS OR PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14007888 ↗
• MalfunctionMar 30, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE (B)(6) 2022. DURING PROCEDURE, DURING AN ATTEMPT TO DEPLOY THE DEVICE, ON IMAGING THE DEVICE PRESENTED IN A COBRA SHAPED DEFORMATION. THE DEVICE WAS REMOVED AND EXCHANGED WITH A NEW 22MM AMPLATZER SEPTAL OCCLUDER. THE DEVICE WAS PLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND HAS BEEN DISCHARGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13946224 ↗