Amplatzer™ Trevisio™ 9-ATV10F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067030948), received between Jan 13, 2021 and Dec 1, 2025 — classified as 1 death, 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. ITHE INTENDED PROCEDURE WAS PERCUTANEOUS POST MI VSD CLOSURE. IT WAS NOTED THAT THE PATIENT DECOMPENSATED DURING THE ADVANCEMENT OF THE DELIVERY SHEATH DUE TO AN INCREASE IN RIGHT HEART OVERLOAD. PRIOR TO THE PROCEDURE, THE PATIENT WAS UNSTABLE, ON MULTIPLE LIFE-SUPPORTING INOTROPIC AGENTS, INTUBATED, AND SEDATED. THE PATIENT HAD SEVERE HEART FAILURE WITH VENTRICULAR DYSFUNCTION AND CARDIOGENIC SHOCK POST-MI, ALONG WITH MULTI-SYSTEM ORGAN FAILURE. THERE WAS NO PRODUCT CONCERN AND NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR THE PROCEDURE. THE DEVICE WAS NEVER IMPLANTED. THE INCREASE IN RIGHT HEART OVERLOAD WAS THOUGHT TO HAVE OCCURRED BECAUSE, DURING ADVANCEMENT OF THE DELIVERY SHEATH, THE TRICUSPID VALVE AND INFARCT AREA WERE HELD OPEN BY THE SHEATH, WHICH CAN EXACERBATE LEFT-TO-RIGHT SHUNTING AND RV OVERLOAD. THE DELIVERY SHEATH ADVANCEMENT WAS SLOW AS IT WAS MANIPULATED OVER THE AV LOOP WIRE AND CROSSED INTO THE LV. THE PATIENT DID NOT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AS DECOMPENSATION OCCURRED DURING THE ATT

  Patient problems: Cardiac Arrest

  MAUDE report 23687553 ↗
• MalfunctionMay 23, 2025Material Invagination; Retraction Problem; Material Invagination; Retraction Problem

  IT WAS REPORTED ON (B)(6) 2025 AN AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE THE OCCLUDER WAS DEPLOYED. AN ATTEMPT WAS MADE TO PARTIALLY RE-SHEATH THE OCCLUDER, HOWEVER IT WAS NOTED THAT THE OCCLUDER COULD NOT BE RE-SHEATHED. THE OCCLUDER AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND INSPECTED. IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS ENFOLDED INTO ITSELF. THE PROCEDURE WAS ABORTED AND THE DECISION WAS MADE TO REFER THE PATIENT TO SURGERY ON A FUTURE DATE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080313 ↗
• MalfunctionMar 19, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644607 ↗
• MalfunctionJan 16, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) AND AN ATRIAL SEPTAL ANEURYSM USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE ORIGINAL SIZING WAS 20×18 MM, AND A 34 MM SIZING BALLOON WAS USED, MAXIMUM MEASURED SIZE WAS 22 MM. BOTH THE AORTIC RIM AND THE SUPERIOR RIM WERE SHORT, CAUSING THE LEFT ATRIAL (LA) DISC TO REPEATEDLY FALL INTO THE RIGHT ATRIUM (RA). ATTEMPTS WERE MADE TO PLACE THE DEVICE FROM THE RIGHT PULMONARY VEIN (PV) USING A FOOTBALL MANEUVER, BUT IT WAS DIFFICULT TO POSITION. AFTER SEVERAL ATTEMPTS TO CORRECT THE COBRA HEAD SHAPE, THE DEVICE WAS FINALLY POSITIONED, BUT THE LA DISC OF THE CS RIM FELL INTO THE RA ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND IT WAS POORLY ALIGNED WITH THE AORTA. WHEN ATTEMPTING TO RETRIEVE AND UPSIZE THE DEVICE, THE DELIVERY CABLE DETACHED AND A NEW 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN. A SNARE WAS USED TO RETRIEVE IT, BUT IT DISLODGED FROM THE SEPTUM AND FLEW INTO THE PV. IT WAS NOTED THAT THE 12F SHEATH WAS KINKED, A NEW 18F NON-ABBOTT LONG SHEATH AND A DOUBLE SNARE WAS USED FOR RETRIEVAL. THE DEVICE WAS SUCCESSFULLY RETRIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173278 ↗
• MalfunctionDec 13, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD) USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS PREPARED BY THE PHYSICIAN AND LOADED INTO THE DELIVERY SYSTEM. BEFORE THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT, THE DEVICE COULD SAFELY EXIT THE LOADER AND WAS THEN REINSERTED INTO THE LOADER. ONCE THE DEVICE WAS INSIDE THE PATIENT, THE LEFT DISC WAS DEPLOYED IN THE LEFT ATRIUM AND THE RIGHT DISC WAS RELEASED IN THE RIGHT ATRIUM. THE POSITIONING WAS NOT SATISFACTORY, SO THE DEVICE WAS RECAPTURED TWICE. ONCE THE LEFT DISC WAS DEPLOYED AGAIN, IT OPENED WITH THE DISTAL NOSE PORTION TOWARDS THE WAIST, ALMOST RESEMBLING A FLOWER SHAPE. WHEN THE DEVICE WAS ATTEMPTED TO BE RECAPTURED, THE DEVICE WOULD NOT RECAPTURE INTO THE SHEATH. THE DEVICE WAS MOSTLY RECAPTURED BUT NOT ENTIRELY. A WIRE WAS USED TO REMOVE THE SHEATH AND THE DEVICE FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICES WERE REPLACED WITH A NEW 28MM AMPLATZER SEPTAL OCCLUDER AND 10F AMPLATZER TREVISIO INTRAVASCULAR D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925791 ↗
• MalfunctionOct 21, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 35MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS MANUALLY ATTACHED AND TURNED 1/8 COUNTERCLOCKWISE AS PER IFU DURING DEVICE PREPARATION. THE OCCLUDER WAS ADVANCED THROUGH THE DELIVERY CABLE "AS PER NORMAL." THE CABLE CONNECTION WAS NOT CHECKED PRIOR TO DEPLOYMENT. DURING DEPLOYMENT, THE OCCLUDER "CAME OFF THE DELIVERY CABLE ON ITS OWN WHILES BEING DEPLOYED. IT WAS IN THE CORRECT POSITION AT THE TIME IT BECAME DETACHED." THEREFORE, NO ATTEMPTS WERE MADE TO RECONNECT THE DEVICE. THE OCCLUDER ULTIMATELY SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495567 ↗
• MalfunctionFeb 23, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN TO CLOSE A POST-INFARCTION VENTRICULAR SEPTAL DEFECT (VSD) IN A HEMODYNAMICALLY UNSTABLE PATIENT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE VSD DIAMETER WAS APPROXIMATELY 18 MM AND A DECISION WAS TO USE A 22 MM OCCLUDER. THE PATIENT HAD AN IMPELLA SUPPORTED AND ONGOING CATECHOLAMINE-THERAPY. DURING PROCEDURE, WHEN THE SHEATH WAS INTRODUCED FROM FEMORAL VEIN, THE WAIST AND RIGHT VENTRICULAR DISC OF THE DEVICE WAS DEFORMED INTO A COBRA HEAD. THE PHYSICIAN TRIED TO RECAPTURE THE DEFORMED OCCLUDER, BUT IT COULD NOT BE WITHDRAWN INTO THE SHEATH. THE SHEATH AND THE PARTIALLY ENFOLDED OCCLUDER HAD TO BE PULLED BACK THROUGH THE PATIENT¿S VSD (BACK INTO THE RIGHT VENTRICLE) AND AT LAST OUT OF THE FEMORAL VEIN. THERE WAS STRONG ANGULATION OF THE SHEATH. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NOT AVAILABLE IN INVENTORY ANOTHER 22 MM OR 24 MM POST-INFARCT VSD OCCLUDER. THEREFORE, A DECISION WAS MADE TO REPLACE THE EXPLANTED 22 MM OCCLUDER WITH A NEW 20MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER AND A NEW 12F A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768432 ↗
• InjuryDec 19, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON 15 NOVEMBER 2023, A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CASE USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, PATIENT WAS UNDER GENERAL ANESTHESIA (GA), DURING THE DEPLOYMENT OF 30MM CRIBRIFORM, THE DEVICE HAD A BULBOUS APPEARANCE. THE 30MM CRIBRIFORM WAS RE-PREPARED AND PUT IN THE PLACE FOR THE SECOND TIME, THERE WAS APPROXIMATELY 4-5 SCREENS/ 30-45 SECONDS OF ST ELEVATION FROM AIR IN THE RIGHT CORONARY ARTERY (RCA). THE IMPLANTER SUSPECTED THE CAUSE OF ST ELEVATION WAS AIR EMBOLUS AND THERE WAS A PERSISTENT LEAK AROUND THE DISTAL END OF THE DEVICE AND THROUGH THE DEVICE. THE CASE OF AIR EMBOLUS WAS THE RESIDUAL AIR FROM FLUSHING THE SYSTEM. THERE WAS NO INTERVENTION FOR THE ST ELEVATION. ALL OTHER VITAL REMAINED STABLE. PATIENT REMIND HEMODYNAMICALLY STABLE AND ECG (ELECTROCARDIOGRAM) RETURNED TO NORMAL WITHIN 1-2 MINUTES. DURING THE DEPLOYMENT, THE DEVICE HAD A BULBOUS APPEARANCE. 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. THE WA

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 18358715 ↗
• MalfunctionSep 1, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023 A 22MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION INTO AN ATRIAL SEPTAL DEFECT (ASD) UTILIZING AN AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFECT WAS MEASURED AS 18MM USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). WHEN ATTEMPTING TO IMPLANT THE DEVICE, THE LEFT DISC FORMED A COBRA HEAD DEFORMITY. THE DEVICE WAS RECAPTURED AND ATTEMPTED TO BE IMPLANTED AGAIN, BUT THE COBRA HEAD DEFORMITY CONTINUED. THE DEVICE WAS ATTEMPTED TO BE RECAPTURED BUT IN THE PROCESS DETACHED FROM THE DELIVERY SYSTEM. THE OCCLUDER TRAVELED TO THE ASCENDING AORTA AND CAUSED A PARTIAL OBSTRUCTION OF BLOOD FLOW. THE DEVICE COULD NOT BE SNARED SO THE PATIENT WAS TRANSFERRED TO OPEN SURGERY IMMEDIATELY TO RETRIEVE THE DEVICE. THE PATIENT WAS REPORTED TO HAVE PROLONGED HOSPITALIZATION DUE TO OPEN HEART SURGERY RECOVERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669725 ↗
• MalfunctionNov 23, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS SELECTED FOR USE TO IMPLANT AN UNKNOWN DEVICE. IT WAS NOTED DURING PROCEDURE THAT THE UNKNOWN DEVICE PREMATURELY DETACHED FROM THE DELIVERY CABLE. THE DECISION WAS MADE TO SNARE THE UNKNOWN DEVICE USING A GOOSE NECK SNARE. THE 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS REPLACED AND THE SAME UNKNOWN DEVICE WAS DEPLOYED USING THE NEW DELIVERY CABLE. 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 15854818 ↗
• InjuryDec 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE. DURING PROCEDURE, AFTER SEVERAL ATTEMPTS AT POSITIONING THE DEVICE (THE DEVICE WAS RE-SHEATHED 4 TIMES), THE DEVICE DISCONNECTED FROM THE DELIVERY CABLE (IN THE ABSENCE OF THE NECESSARY MANEUVERS FOR RELEASE). THE DEVICE MIGRATED INTO THE LEFT VENTRICLE. ATTEMPTS WERE MADE TO RECAPTURE DEVICE IN THE CATH LAB BUT WERE UNSUCCESSFUL. THE STABLE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR SURGICAL REMOVAL OF THE DEVICE AND SURGICAL REPAIR OF THE DEFECT. ALTHOUGH THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, THE EVENT DID CAUSE A PROLONGED HOSPITALIZATION, A STAY IN THE INTENSIVE CARE AND MECHANICAL VENTILATION. THE PATIENT HAS SINCE BEEN DISCHARGED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085749 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00017. ON (B)(6) 2020, A 24 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEVICE PLACEMENT, WHILE THE LEFT DISC WAS DEPLOYED, THE PHYSICIAN WANTED TO CHANGE THE ORIENTATION OF THE DEVICE. WHILE THE PHYSICIAN ATTEMPTED TO RECAPTURE THE DEVICE, IT WAS REALIZED THAT THE OCCLUDER HAD BECAME DISCONNECTED FROM THE AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM DELIVERY CABLE. THE DELIVERY CABLE WAS ABLE TO SCREWED BACK ONTO THE OCCLUDER AND WAS SUBSEQUENTLY RECAPTURED AND REMOVED. A NEW AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM WAS THEN USED TO SUCCESSFULLY IMPLANT A NEW 24 MM AMPLATZER SEPTAL OCCLUDER. 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; No Known Impact Or Consequence To Patient

  MAUDE report 11165623 ↗