Amplatzer™ 9-ASD-MF-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00811806010311), received between Aug 21, 2018 and Feb 13, 2026 — classified as 1 death, 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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.

• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335290 ↗
• MalfunctionMay 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SHEATH. DURING IMPLANT, WHEN THE OCCLUDER WAS DEPLOYED, THE LEFT DISC DEFORMED INTO A TULIP SHAPE. THE OCCLUDER WAS RELOADED, HOWEVER THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. IT WAS EXCHANGED FOR A NEW 35MM AMPLATZER CRIBRIFORM OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038222 ↗
• MalfunctionNov 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER DEFORMED WITH A BULBOUS SHAPE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES AND NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE AND WAS NOT IMPLANTED. NO DEVICE WAS ULTIMATELY IMPLANTED DUE TO NO SPARE STOCK AVAILABLE AT THE HOSPITAL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678435 ↗
• InjuryOct 16, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS IMPLANTED. THE SIZING OF THE DEVICE WAS DETERMINED VIA ECHO. STABILITY CHECK WAS PERFORMED AND NO LEAK WAS OBSERVED. THERE WERE NO REPORTED DIFFICULTIES DURING IMPLANT. ONE HOUR POST-IMPLANT, THE OCCLUDER COMPLETELY DISLODGED FROM THE IMPLANT SITE AND EMBOLIZED TO THE PULMONARY ARTERY. IT IS SUSPECTED THAT INTRA-CARDIAC IMAGING DID NOT SUPPORT FULLY ENSURING THE OCCLUDER WAS FULLY IMPLANTED. THE PATIENT DID NOT EXPERIENCE A RHYTHM CHANGE DURING PROCEDURE, BUT DID EXPERIENCE ARRYTHMIA 1.5 HOURS POST-IMPLANT. THE OCCLUDER WAS SNARED PERCUTANEOUSLY WITH AN 18F SNARE AND REMOVED. A NEW 30MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. OF NOTE, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS MIS-SIZED PRIOR TO THE 35MM CRIBRIFORM. THERE ARE NO ALLEGATIONS OF MALFUNCTION WITH THE 25MM CRIBRIFORM.

  Patient problems: Arrhythmia

  MAUDE report 20463383 ↗
• MalfunctionJul 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING IMPLANT THE LEFT DISC OF THE DEVICE TOOK ON A MUSHROOM SHAPE TWICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH AN UNKNOWN DEVICE. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19732935 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS IMPLANTED IN A PATIENT. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL WITH TACHYCARDIA AND WAS DIAGNOSED WITH PERICARDITIS. THE PATIENT WAS ADMITTED AND MONITORED WITH SERIAL ECHO'S FOR 36 HOURS AND THEN DISCHARGED HOME WITH THE DEVICE STILL WORKING AS INTENDED. PATIENT STABLE.

  Patient problems: Pericarditis; Tachycardia

  MAUDE report 19619681 ↗
• MalfunctionMar 14, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE LEFT DISK WAS BULBUS AND THE LEFT DISK WAS NOT LAYING FLAT. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE CABLE AND TRIED OUTSIDE THE PATIENT BODY AND IT WAS STILL NOT LOOKING FLAT. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. DEVICE WAS REPLACED WITH A NEW 35MM AMPLATZER CRIBRIFORM OCCLUDER THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909376 ↗
• MalfunctionNov 21, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 01 NOVEMBER 2023, A 35MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM CHOSEN FOR IMPLANT USING A AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER FORMED A SPHERICAL 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. THE PHYSICIAN DECIDED TO STOP 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 REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187909 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 35MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR IMPLANT USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. IT WAS NOTED THAT THE PATIENT HAD A COMPLEX FENESTRATED ATRIAL SEPTAL DEFECT. WHEN ATTEMPTING TO PLACE THE DEVICE, IT WAS NOTED THAT THE DEVICE WAS TOO LARGE AND HEART BLOCK OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT BODY BEFORE IT WAS RELEASED FROM THE DELIVERY SYSTEM. THERE WAS NO 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM AVAILABLE FOR IMPLANT. NO REPLACEMENT DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS DISCHARGED.

  Patient problems: Heart Block

  MAUDE report 17282792 ↗
• MalfunctionNov 4, 2022Difficult 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) 2022, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT THE RIGHT ATRIAL DISC OF THE OCCLUDER EXHIBITED A DEFORMATION. IN ADDITION, THE OCCLUDER WAS DIFFICULT TO SCREW ON AND COULD NOT BE DEPLOYED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 35MM AMPLATZER CRIBRIFORM OCCLUDE WITH A NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729160 ↗
• InjuryOct 21, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM AMPLATZER MULTI- FENESTRATED SEPTAL OCCLUDER CRIBRIFORM WAS IMPLANTED INTO A PATIENT. SIZING OF THE DEVICE WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY. DURING THE DEPLOYMENT, THE PATIENT REFLEXIVELY COUGHED, CAUSING PART OF THE RIGHT DISC TO CROSS THE PATENT FORAMEN OVALE TUNNEL. IT WAS ATTEMPTED TO MOVE THE DEVICE BACK INTO POSITION USING A LASSO, BUT THE DEVICE EMBOLIZED INTO THE LEFT VENTRICLE. THE PATIENT WAS BROUGHT TO SURGERY AND THE DEVICE WAS REMOVED, AND THE PATENT FORAMEN OVALE WAS SUTURED. THE PATIENT IS REPORTED TO BE STABLE AND RECOVERING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655182 ↗
• MalfunctionAug 25, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE, FIRST DISC REMAINED ROUNDED AT THE OPENING. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE ATRIAL SEPTUM DURING THE OPENING OF THE DEVICE OR ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NEW 35MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297250 ↗
• DeathApr 11, 2022Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2022, A 35MM AMPLATZER CRIBRIFORM OCCLUDER (7973668) WAS IMPLANTED INTO A VENTRICULAR SEPTAL DEFECT (VSD) AND RELEASED FROM THE DELIVERY CABLE. IT WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) COLOR DOPPLER THAT THERE WAS STILL A LEAK PRESENT. THE DELIVERY SYSTEM WAS ADVANCED THROUGH THE LEAK, AND THE OCCLUDER DISLODGED AND EMBOLIZED AS THE DELIVERY SYSTEM WAS BEING ADVANCED. THE DEVICE TRAVELED TO THE PATIENT'S LEFT VENTRICLE (LV). A 20MM GOOSENECK SNARE WAS OPENED AND ADVANCED INTO THE LV. AFTER TRYING TO SNARE THE DEVICE A COUPLE TIMES, THE PATIENT'S CONDITION WORSENED, SO RETRIEVAL OF THE DEVICE WAS ABANDONED. A 35MM AMPLATZER CRIBRIFORM OCCLUDER (7098008) WAS LOADED ONTO THE CABLE AND WAS ATTEMPTED TO CLOSE THE DEFECT, BUT IT WAS DETERMINED TO BE TOO SMALL. THIS DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND DIED ON (B)(6) 2022. IT WAS THOUGHT THAT THE DEATH WAS DUE TO A COMBINATION OF THE PROCEDURE AND THE PATIENT'S COMORBIDITIES. PRIOR TO PROCEDURE, THE PATIENT HAD A POST-MYOCARDIAL INFARCTION VENTRICULAR SEPTAL DEFECT AND WAS INTUBATED IN THE INTENSIVE CARE

  Patient problems: Cardiac Tamponade; Embolism/Embolus

  MAUDE report 14073429 ↗
• MalfunctionNov 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE DEPLOYING THE DEVICE, THE LEFT DISC PRESENTED IN A BULBOUS DEFORMATION. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT WHERE THE DEVICE WAS TESTED, AND AGAIN PRESENTED AS DEFORMED. THE DEVICE WAS REPLACED WITH ANOTHER ABBOTT DEVICE, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756523 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 6MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. THE PHYSICIAN CROSSED THE ANTERIOR DEFECT AND ATTEMPTED TO DELIVER THE AMPLATZER SEPTAL OCCLUDER HOWEVER, IT DIDN'T OCCLUDE THE 3 DEFECTS AND WAS DEEMED TOO SMALL. THE DEVICE WAS EXCHANGED FOR A 35MM AMPLATZER CRIBRIFORM OCCLUDER AND THE DEVICE COVERED ALL DEFECTS AND THE DEVICE WAS RELEASED. AFTER REMOVING THE DELIVERY SHEATH, COMPRESSION ON THE RIGHT FEMORAL VEIN WERE APPLIED. NO MAJOR BLEEDING WAS NOTED AND THE PATIENT WAS REPORTED TO BE STABLE. LATER, THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFRACTION AND A CODE BLUE WAS CALLED. CHEST DECOMPRESSIONS WERE ATTEMPTED AND THE PATIENT UNDERWENT CARDIAC DEFIBRILLATION. A TRANSTHORACIC ECHOCARDIOGRAPHY AND RAPID ANGIOGRAPHY WAS PERFORMED AND SHOWED NO CARDIAC TAMPONADE, AORTIC PREFORMATION OR RIGHT CORONARY INFRACTS. IT IS THOUGHT THAT THAT THE PATIENT POSSIBLY HAD RIGHT VENTRICLE (RV) FAILURE AND A AN IMPELLA RP HEART PUMP WAS IMPLANTED. ONCE THE PATIENT WAS STABLE, SHE WAS TRANSFERRED TO STANFORD MEDICAL CENTER WHERE SHE MAY BECOME A CANDIDATE FOR HEART TRANSPLANT. IT IS UNKNOWN WHAT CAUSED THE MYOCARDIA INFRACTION, HOWEVER IT IS THO

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 12511831 ↗
• InjuryMay 26, 2021Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON (B)(6) 2021, A 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) PROCEDURE. DURING THE PROCEDURE, THE DEVICE HAD EMBOLIZED INTO THE RIGHT ATRIUM. THE INITIAL ATTEMPT TO RETRIEVE THE DEVICE BY SNARING ON (B)(6) 2021 WAS UNSUCCESSFUL. THE DEVICE WAS LEFT IN THE PATIENTS INFERIOR VENA CAVA (IVC) UNTIL THE SCHEDULED RETRIEVAL VIA SNARING PROCEDURE ON (B)(6) 2021. THE RETRIEVAL WAS SUCCESSFUL AND NO SURGICAL INTERVENTION WAS REQUIRED. THERE WAS ALLEGATION OF CARDIAC ANOMALIES AND THE PATIENT REMAINED STABLE THROUGHOUT BOTH PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884347 ↗
• InjuryMar 18, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IN 2013 TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) IMAGING WAS DONE AND IT REVEALED A PATENT FORAMEN OVALE (PFO). ON (B)(6) 2020, IMAGING DURING THE INTERVENTION WAS INTRA-CARDIAC ECHOCARDIOGRAPHY (VIEWFLEX CATHETER) AND A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED AND SUCCESSFULLY IMPLANTED IN THE PATIENT. THREE MONTHS POST-PROCEDURE, THE PATIENT HAD AN ECHO FOLLOW UP AND THE PHYSICIAN DISCOVERED THE DEVICE HAD EMBOLIZED INTO THE LEFT VENTRICULAR OUTFLOW. THE PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2021. THE PATIENT HAD A SURGICAL INTERVENTION TO REMOVE THE AMPLATZER CRIBRIFORM OCCLUDER. NO OTHER DEVICE WAS IMPLANTED AND THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Foreign Body Embolism

  MAUDE report 11520514 ↗
• MalfunctionJan 12, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ON (B)(6) 2020, A 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. WHILE ATTEMPTING TO IMPLANT THE DEVICE THERE WAS A DEPLOYMENT FAILURE. WHILE DOING A TEST DEPLOYMENT ON THE DEVICE, THE OCCLUDER WAS FOUND TO BE DEFORMED. THE DEVICE WAS REMOVED AND REPLACED WITH A 30 MM AMPLATZER CRIBRIFORM OCCLUDER TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11154795 ↗
• MalfunctionJan 5, 2021Material Deformation; Material Deformation

  ON (B)(6) 2020, A 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. WHILE DEPLOYING, THE DEVICE WOULDN'T RETURN TO ITS NORMAL SHAPE. THE OCCLUDER WAS RECAPTURED AND REMOVED TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11120209 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, DURING PFO PROCEDURE, THE OCCLUDER CLOSURE SYSTEM DID NOT ALLOW A PROPER DEPLOYMENT OF THE PROTHESIS. THE DEVICE WAS IN CONTACT WITH THE PATIENT AND THE DEFORMATION WAS NOTICED DURING THE DEPLOYMENT OF THE LEFT AND RIGHT DISCS BEFORE THE DEVICE WAS RELEASED. THE LEFT DISC APPEARED SWOLLEN AND THE HUB TWISTED. THE DEVICE WAS EXCHANGED WITH A NEW AMPLATZER OCCLUDER DEVICE, 9-ASD-MF-035. NO CLINICAL CONSEQUENCES WERE OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11057763 ↗
• MalfunctionApr 14, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 30MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING AN AMPLATZER TORQVUE DELIVERY SYSTEM (9-ITV10F45/80). DURING THE PROCEDURE THE DEVICE COULD NOT CATCH THE AORTIC RIM AS THE DIRECTION OF THE DISC WAS PERPENDICULAR TO THE AORTIC RIM, SO THE PHYSICIAN ADJUSTED THE DIRECTION OF THE DELIVERY SYSTEM AND RE-DEPLOYED THE DEVICE. UPON DEPLOYMENT BOTH THE LA AND RA DISCS FORMED A DOUGHNUT SHAPE. THE DEVICE WAS RE-SHEATHED AND REMOVED FROM THE PATIENT. THE PHYSICIAN DEPLOYED THE DEVICE OUTSIDE THE PATIENT AND AGAIN THE DISCS FORMED A DOUGHNUT SHAPE. THE PHYSICIAN DECIDED TO UPSIZE TO A 35MM AMPLATZER CRIBRIFORM OCCLUDER BECAUSE THE 30MM DEVICE DID NOT SEEM BIG ENOUGH. USING THE 10F DELIVERY SYSTEM, THE FIRST DEPLOYMENT WAS UNSUCCESSFUL, DURING THE SECOND ATTEMPT THE DISCS FORMED A DOUGHNUT SHAPE AGAIN, BUT AFTER THE WIGGLE TEST THE DISC BECAME ACCEPTABLE. THE 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. REFERENCE MANUFACTURING REPORT NUMBER 2135147-2020-00147.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960250 ↗
• InjuryMar 19, 2020Biocompatibility; Human-Device Interface Problem; Biocompatibility; Human-Device Interface Problem

  ON (B)(6) 2020, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT WITH A MULTIFENESTRATED ASD. THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE ACCORDING TO THE IFU, BUT AFTER THE DEVICE WAS DEPLOYED A SMALL SHUNT ACROSS THE SEPTUM WAS NOTED THROUGH TEE. THE PHYSICIAN DECIDED TO RETRACT THE DEVICE AND REMOVE THE DEVICE FROM THE PATIENT. ONCE THE 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS REMOVED IT WAS FOUND TO HAVE WHAT APPEARED TO BE A CLOT ON THE DEVICE. THE PHYSICIAN ORDERED ADDITIONAL HEPARIN AND RECHECKED THE ACT. THE ACT WAS CONFIRMED AT 270. A NEW 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT AND THROUGH TEE IT WAS CONFIRMED TO HAVE SUCCESSFULLY OCCLUDED THE MULTIFENESTRATED ASD. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 9856279 ↗
• InjuryNov 18, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F DELIVERY SYSTEM (LOT NUMBER: UNKNOWN). UPON DEPLOYMENT, THE PHYSICIAN REPORTED ONE OF THE DISC TO BE BOLUS. THE DEVICE WAS EXCHANGED FOR ANOTHER 35MM AMPLATZER CRIBRIFORM OCCLUDER (LOT NUMBER: UNKNOWN) AND THE SAME ISSUE OCCURRED. A 18MM SIZING BALLOON WAS USED TO SIZE THE DEFECT AND A 22MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6087998) WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339040 ↗
• InjuryNov 18, 2019Defective Component

  ON (B)(6) 2019, A 35 MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F DELIVERY SYSTEM (LOT NUMBER: UNKNOWN). UPON DEPLOYMENT, THE PHYSICIAN REPORTED ONE OF THE DISC TO BE BOLUS. THE DEVICE WAS EXCHANGED FOR ANOTHER 35 MM AMPLATZER CRIBRIFORM OCCLUDER (LOT NUMBER: UNKNOWN) AND THE SAME ISSUE OCCURRED. A 18 MM SIZING BALLOON WAS USED TO SIZE THE DEFECT AND A 22 MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6087998) WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9339027 ↗
• MalfunctionNov 1, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, A 35MM AMPLATZER CRIBRIFORM OCCLUDER (LOT/BATCH #: 6547232) WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION A "SOMBRERO-LIKE" DEFORMATION WAS NOTED. THE DEVICE WAS EXCHANGED FOR ANOTHER 35MM AMPLATZER CRIBRIFORM OCCLUDER (LOT/BATCH #: 5967154 ). DURING DEPLOYMENT OF THE SECOND DEVICE A COMBINATION OF A "SOMBRERO" AND "COBRA-LIKE" DEFORMATION WAS NOTED. THE DEVICE WAS RESHEATHED AND REMOVED. THE PHYSICIAN DECIDED TO SEND THE PATIENT TO SURGERY. AFTER FINISHING THE PROCEDURE A PERICARDIAL EFFUSION WAS NOTED BUT NOT PRODUCT RELATED. THE PATIENT UNDERWENT EMERGENCY SURGERY. THE PATIENT WAS REPORTED TO BE STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2135147-2019-00361.

  Patient problems: Pericardial Effusion

  MAUDE report 9266057 ↗