Amplatzer™ Septal Occluder (REF 9-ASD-019)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00811806010168), received between Jan 14, 2019 and Dec 22, 2025 — classified as 1 death, 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS OBSERVED THAT THE DEVICE CONFORMED INTO A COBRA DEFORMATION. THE DEFORMED DEVICE WAS RELEASED FROM THE DELIVERY CABLE INSIDE THE PATIENT. 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 20MM 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 23872884 ↗
• MalfunctionDec 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE DEVICE CONFORMED INTO A COBRA-LIKE SHAPE. THERE WERE TWO RECAPTURES AND TWO MORE DEPLOYMENTS WHICH RESULTED IN 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 20MM 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 23854515 ↗
• MalfunctionSep 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043064 ↗
• MalfunctionJun 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THERE WAS SOME CONTACT WITH CARDIAC STRUCTURES. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 19MM AMPLATZER SEPTAL OCCLUDER AND 8F AMPLATZER TREVISIO INTRAVASCULAR 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 22133384 ↗
• InjuryMay 8, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21988039 ↗
• MalfunctionMay 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943318 ↗
• MalfunctionApr 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F NON-ABBOTT SHEATH. DURING PROCEDURE, WHILE DEPLOYING THE DEVICE, IT WAS NOTED THAT IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WASN'T USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909953 ↗
• MalfunctionMar 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F NON-ABBOTT SHEATH. DURING PROCEDURE, THE PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE AND HAD A COBRA DEFORMATION, 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559732 ↗
• MalfunctionFeb 12, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6)2025, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A 17×14 ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZING OF THE DEVICE WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). DURING PROCEDURE, THE RIGHT ATRIAL DISC WAS DISLODGED INTO THE LEFT ATRIUM (LA) WITH WIGGLED. THE PATIENT HAD A VERY SMALL LEFT ATRIUM, MAKING THE PLACEMENT CHALLENGING. THE DEVICE WAS NOT RELEASED FORM THE DELIVERY CABLE. THE PHYSICIAN MENTIONED THE CAUSE OF MIGRATION WAS FLOPPY POSTERIOR AND INFERIOR RIMS. A NEW 20MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY REPLACED WITH THE SAME DELIVERY SYSTEM AND THE CLOSURE WAS COMPLETED. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369193 ↗
• InjuryJan 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER DEPLOYING THE LEFT ATRIAL DISC AND PULLING IT TOWARDS THE SEPTUM, THE OCCLUDER WAS OBSERVED TO HAVE PRE-MATURELY DISCONNECTED FROM THE DELIVERY CABLE WHILE ATTEMPTING TO RETRACT THE OCCLUDER BACK TO THE RIGHT ATRIUM. ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) A COMPRESSION OF THE AORTIC ROOT WAS SEEN. THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 12F NON-ABBOTT GUIDING SHEATH. THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. THE SAME OCCLUDER WAS ATTEMPTED TO BE CONNECTED TO THE 12F SHEATH, BUT IT DISCONNECTED WHILE ATTEMPTING TO PULL IT INTO THE SHORT SHEATH. THE OCCLUDER WAS REPLACED WITH A NEW 20MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 21069273 ↗
• InjuryJul 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN A PATIENT. DURING SURGERY PERFORATION WAS DESCRIBED BY A HOLE 1MM PUNCTIFORM NEAR THE NON CORONARY SINUS. IT IS UNKNOWN IF ANY INTERVENTION WAS PERFORMED AT THAT TIME. ON (B)(6) 2024, THE PATIENT HAD AORTA PERFORATION EROSION POST PROCEDURE. THE PATIENT WAS TRANSFERRED TO SURGERY TO CLOSE HOLE IN THE AORTA. THE PATIENT IS STABLE.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 19751399 ↗
• DeathApr 16, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT WAS IN SINUS RHYTHM DURING PROCEDURE. THE DEFECT MEASURED AS 1.6MM ON ECHOCARDIOGRAPHY. ECHOCARDIOGRAPHIC AND FLUOROSCOPIC GUIDANCE WERE USED DURING PROCEDURE. THERE WAS DIFFICULTY IMPLANTING THE DEVICE. THE DEVICE WAS REPOSITIONED SEVERAL TIMES, AND THE EDGE OF THE INFERIOR VENA CAVA WAS LEFT OUT. FINALLY THE EDGES INSIDE THE DEVICE WERE VISUALIZED. A STABILITY CHECK WAS PERFORMED, AND THE DEVICE WAS IMPLANTED. APPROXIMATELY 12 HOURS AFTER IMPLANTATION, THE DEVICE EMBOLIZED TO THE PATIENT'S LEFT ATRIUM. ON (B)(6) 2024, THE PATIENT WAS TAKEN TO THE PROCEDURE ROOM TO REMOVE THE DEVICE, AND ATTEMPTS WERE MADE TO REMOVE THE DEVICE FROM THE PATIENT'S HEART VIA TRANSCATHETER SNARE. VENOUS ACCESS WAS MADE, AND A TEMPORARY PACEMAKER WAS PLACED AND RESUSCITATED. THE DEVICE HAD INTERACTION WITH THE MITRAL VALVE AND TRAVELLED TO THE LEFT VENTRICULAR OUTLET. THE DEVICE CAUSED AN OBSTRUCTION TO BLOOD FLOW AT THE LEFT VENTRICULAR OUTLET. THE DEVICE WAS ATTEMPTED TO BE EXTRACTED BUT WAS NOT ABLE TO BE RECOVERED. THE PATIENT ENTERED

  Patient problems: Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 19115552 ↗
• MalfunctionApr 1, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6)2024, A 19MM AMPLATZER SEPTAL OCCLUDER (LOT: 8727221) WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN 9F DELIVERY SYSTEM. WHEN DEPLOYING WITHIN THE LEFT ATRIUM, THE OCCLUDER FORMED A COBRA DEFORMATION. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND WAS WASHED IN HEPARINIZED SALINE WHICH RETURNED THE OCCLUDER TO THE CORRECT SHAPE. THE OCCLUDER WAS REINSERTED AND ATTEMPTED TO DEPLOY, BUT THE COBRA DEFORMATION OCCURRED AGAIN. THE OCCLUDER WAS REMOVED AND A REPLACEMENT 19MM AMPLATZER SEPTAL OCCLUDER (LOT: 7266961) WAS IMPLANTED SUCCESSFULLY UTILIZING THE SAME DELIVERY SYSTEM. THE DEVICE DID NOT INTERACT WITH CARDIAC STRUCTURES AND THERE WERE NO ANGULATION OR BENDS IN THE DELIVERY SYSTEM. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014553 ↗
• MalfunctionJan 16, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AA UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE HAD A COBRA DEFORMATION AND IT WAS NOT SITTING PROPERLY IN THE DEFECT. 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 20MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN. DURING DEVICE PREPARATION, THE DEVICE HAD A COBRA DEFORMATION. THE DOCTOR FINALLY USED A 20MM NON-ABBOTT DEVICE AND CLOSED THE DEFECT. 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. THERE WAS NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518051 ↗
• MalfunctionDec 27, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE. DURING DEVICE PREPARATION, IT WAS NOTICED THE DEVICE HAD LONG POLYESTER STRANDS EXTENDING OUT OF THE LEFT ATRIAL DISC AND THE WAIST OF THE DEVICE. A DECISION WAS MADE TO REPLACE THE DEVICE WITH A SECOND 19MM AMPLATZER SEPTAL OCCLUDER. WHEN THE SECOND DEVICE WAS OPENED DURING DEVICE PREPARATION, IT WAS ALSO NOTED THERE WAS A STRAND OF FIBER STICKING OUT OF THE LEFT ATRIAL DISC. THE PHYSICIAN PUSHED THE STRAND BACK INTO THE DEVICE AND CONTINUED WITH DEVICE PREPARATION. THE SECOND DEVICE WAS SUCCESSFULLY DEPLOYED AND IMPLANTED WITH A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM IN THE PATIENT'S ATRIAL SEPTAL DEFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399629 ↗
• MalfunctionNov 15, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT ON(B)(6) 2023 USING A 10F MULLINS GUIDING SHEATH. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT BEFORE IT WAS RELEASED FROM THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS IN THE DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS IS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145599 ↗
• InjurySep 21, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. THE DEVICE WAS SIZED USING SIZING BALLOON AND ECHOCARDIOGRAM. DEVICE WAS DEPLOYED WITH MINIMUM ISSUES, HOWEVER IT EMBOLIZED THE NEXT DAY INTO THE PATIENTS DESCENDING ABDOMINAL AORTA. IT WAS SAFELY RETRIEVED LATER THAT DAY ON (B)(6) 2023. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788985 ↗
• MalfunctionAug 3, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT TO TREAT ATRIAL SEPTAL DEFECT (ASD), USING 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE ASD WAS MEASURED TO BE 1.7X1.3MM USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE). THE CASE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CONTROL. A 24MM SIZING BALLOON WAS INFLATED TO 17ML TO STOP FLOW ON ICE IMAGES. WAIST OF BALLOON WAS MEASURED TO BE 15.9MM ON FLUOROSCOPY. ICE IMAGE MEASURES 16.2MM. SIZING PLATE USED WITH BALLOON INFLATED TO 17ML. BALLOON WAS TIGHT AT 18MM MEASURING HOLE. DURING DEPLOYMENT OF THE DEVICE, THE LEFT DISC IMMEDIATELY FORMED A COBRA HEAD. THE DEVICE WAS RE-SHEATHED AND REMOVED, AND IT REMAINED IN A COBRA HEAD DEFORMITY OUTSIDE THE PATIENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. A REPLACEMENT 20MM AMPLATZER SEPTAL OCCLUDER WAS DEPLOYED WITH NO REPORTED ISSUE. THE PATIENT WAS REPORTED TO BE STABLE AND RECOVERING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THIS ISSUE REPORTEDLY CAUSED A CLINICALLY SIGNIFICANT DELAY, BUT THE DELAY DID NOT RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454856 ↗
• InjuryJul 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE ASO HAD BEEN SIZED USING A 24MM AMPLATZER SIZING BALLOON AND ICE EXAMINATION IT WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT 15 SECONDS AFTER RELEASE THE ASO EMBOLIZED INTO THE LEFT ATRIUM. IN ADDITION, THE PATIENT WAS FOUND TO HAVE PERICARDIAL EFFUSION. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE VIA SNARE, HOWEVER WAS UNSUCCESSFULLY. THE PATIENT THEN UNDERWENT EMERGENT OPEN HEART SURGERY TO HAVE THE ATRIAL SEPTAL DEFECT REPAIRED, ASO REMOVED, PERICARDIAL EFFUSION DRAINED, AND PERFORATION REPAIRED. IT WAS NOTED DURING THE EXPLANT PROCEDURE THAT AT AN UNKNOWN POINT, THE PATIENT'S MITRAL VALVE HAD SUSTAINED AN INJURY. THE PATIENT WAS SENT TO ANOTHER HOSPITAL AND PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO); THE PATIENT IS WAITING TO UNDERGO SURGERY TO TREAT THE INJURED MITRAL VALVE.

  Patient problems: Cardiac Perforation; Mitral Perforation; Pericardial Effusion

  MAUDE report 15099426 ↗
• MalfunctionApr 3, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, THE DEVICE PRESENTED IN A COBRA DEFORMATION WHILE BEING DEPLOYED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 19 MM AMPLATZER TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE EVENT REPOSTED. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992386 ↗
• InjuryFeb 24, 2022Migration or Expulsion of Device; Positioning Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Positioning Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DEVICE WAS SIZED USING AN 18MM UNKNOWN MANUFACTURER BALLOON SIZING. DURING THE DEPLOYMENT OF THE DEVICE, THE DEVICE SHIFTED POSITION WITHIN THE INTENDED SITE AND OBSTRUCTED THE FLOW OF THE AORTA; THE PATIENT HAD SEVERE SEPTAL ANEURYSMS AND THE ATRIOVENTRICULAR (AV) RIM WAS PRESSED BY THE DEVICE. THE PATIENT WENT INTO CARDIAC ARREST AND WAS SENT TO SURGERY. THE DEVICE CAME OUT OF THE PATIENT WITHOUT BEING DETACHED FROM THE DELIVERY CABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS THE RESULT OF SEVERE SEPTAL ANEURYSMS AND ATRIOVENTRICULAR (AV) RIM WAS PRESSED BY THE DEVICE. PATIENT STABLE, THE PATIENT DID NOT HAVE A HISTORY OF ANEURYSMS, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 13592156 ↗
• MalfunctionDec 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2021, A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. UPON DEPLOYMENT, A COBRA DEFORMATION ON THE DISTAL DISC WAS NOTED. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PATIENT WAS REFEREED TO SURGICAL REPAIR. THE PATIENT STATUS IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13045936 ↗
• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 19 AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEVICE PREP, A DEFORMATION WAS NOTED BUT THE DEVICE WAS USED ANYWAY. DURING THE IMPLANT PROCEDURE, THE DEVICE WAS POSITIONED AND AGAIN DEPLOYED IN A COBRA DEFORMATION. THE DEVICE WAS REMOVED AND REPLACED WITH A 18 MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THOUGH. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866083 ↗
• MalfunctionDec 18, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE LEFT ATRIAL DISC FORMED A COBRA SHAPE, AND THE DEVICE HAD DIFFICULTY BEING RE-SHEATHED TO BE RECAPTURED. THE PHYSICIAN SUCCESSFULLY RECAPTURED THE DEVICE, AND IT WAS REMOVED FROM THE PATIENT WITHOUT FURTHER INCIDENT. THEN, THE PATIENT WAS REFERRED FOR SURGERY FOR SURGICAL CLOSURE. OF NOTE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC ARREST DURING THE SECOND SURGERY AND ON (B)(6) 2020, THE PATIENT PASSED AWAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11037171 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A 19MM AMPLATZER SEPTAL OCCLUDER(ASO) WAS SELECTED FOR IMPLANT. WHEN DEPLOYING THE ASO IN THE LEFT ATRIUM, THE ASO BECAME DETACHED FROM THE DELIVERY CABLE. THE PHYSICIAN ATTEMPTED TO REMOVE THE ASO PERCUTANEOUSLY BY A SNARE CATHETER BUT FAILED. AN EMERGENCY SURGERY WAS PERFORMED ON THE SAME DATE. IT WAS THOUGHT THAT THE ASO HAD NOT BEEN CONNECTED FIRMLY ENOUGH TO THE DELIVERY CABLE DURING PREPARATION; THE PHYSICIAN ATTRIBUTES THE ISSUE TO HIS PROCEDURE AND NOT DUE TO THE ASO FAILURE. THERE WAS A DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317624 ↗