Amplatzer™ Trevisio™ 9-ATV12F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05415067030955), received between Aug 9, 2022 and Dec 13, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Positioning Problem; Patient Device Interaction Problem; Positioning Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 34MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON(B)(6) 2024 USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE DIAMETER OF THE ASD WAS MEASURED AT 27X30MM. THE INFERIOR AND POSTERIOR RIMS WERE MORE THAN 5MM. THE PATIENT HAD A SMALL SUPERIOR RIM AND NO AORTIC RIM. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 248 SECONDS AT THE START OF THE PROCEDURE. DURING THE PROCEDURE POSITIONING WAS DIFFICULT AND THE OCCLUDER WAS PARTIALLY RE-CAPTURED MULTIPLE TIMES. THE OCCLUDER WAS FULLY RE-CAPTURED AND REMOVED FROM THE PATIENT AND DEPLOYED TO CONFIRM THE OCCLUDER WAS STILL FIRMLY ATTACHED TO THE DELIVERY CABLE. THE OCCLUDER WAS WASHED WITH HEPARINIZED SALINE. THE OCCLUDER WAS RE-LOADED AND RE-INSERTED INTO THE PATIENT. DURING DEPLOYMENT A CLOT WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WHILE THE LEFT DISC OF THE OCCLUDER WAS PARTIALLY DEPLOYED. IT WAS UNKNOWN IF THE CLOT WAS ATTACHED TO THE OCCLUDER, OR THE TIP OF THE DELIVERY SHEATH, OR IN-BETWEEN BOTH DEVICES. LATER IN THE PROCEDURE A THROMBUS WAS NOTED IN THE LEFT ATRIAL APPENDAGE (LAA). IT WAS UNKNOWN IF IT WAS THE SAME CLOT THAT WAS PRE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20928200 ↗
• MalfunctionJul 26, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT IT WAS NOTED THAT THERE WAS AIR ENTRAPPED IN THE LOADER OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE USER BELIEVED THE CONNECTION BETWEEN THE TOUHY-BORST AND THE LOADER WAS NOT SEALING CORRECTLY, WHICH ALLOWED AIR TO ENTER INTO THE SYSTEM IN THAT LOCATION. THERE WAS NO LEAK NOTED IN THE DELIVERY SYSTEM. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839334 ↗
• InjuryJan 29, 2024Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON 04 JANUARY 2024, A 36MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION AFTER FULL DEPLOYMENT. THE LEFT DISC OPENED WELL, BUT THE RIGHT DISC COULD NOT OPEN AND FORMED A COBRA SHAPE. 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. WHEN THE IMPLANTER TRIED TO PULL IN THE DEVICE AND RETRIEVE THE SHEATH, THE LEFT DISC WAS NOT ABLE RE-SHEATH. THE IMPLANTER USED GREAT FORCE TO PULL DEVICE INTO SHEATH, WITH THE DISTAL PART STILL PARTIALLY EXPOSED OUTSIDE THE SHEATH WHILE REMOVING THE WHOLE SYSTEM. THIS CAUSED A TEAR IN THE FEMORAL VEIN, BUT NO MAJOR BLEEDING OCCURRED. UPON INSPECTION, THE DELIVERY SYSTEM HAD CRUMBLED DUE TO THE FORCE USED TO RETRACT THE DEVICE. A NEW 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18596627 ↗
• MalfunctionOct 3, 2023Material Invagination; Retraction Problem; Material Deformation; Material Invagination; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 38MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION INTO AN ATRIAL SEPTAL DEFECT (ASD) UTILIZING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. AFTER POSITIONING THE RIGHT DISC OF THE OCCLUDER, THE LEFT DISC HAD A BULBOUS SHAPED DEFORMITY. IT WAS DECIDED TO RETRIEVE THE DEVICE AND REMOVE FROM ANATOMY. HOWEVER, THE LEFT DISC WOULD NOT REENTER THE SHEATH AS IT WAS IN A SMALL BALL SHAPE. AFTER SEVERAL ATTEMPTS AND "UNTWISTING" THE CABLE, THE DEVICE WAS ABLE TO ENTER THE SHEATH. WHEN REMOVING THE SHEATH, THE BLUE TIP OF THE SHEATH WAS OBSERVED TO BE FOLDED IN. OUTSIDE OF THE BODY, THE OCCLUDER HELD THE BULBOUS SHAPE. THERE WAS NO KINK OR ANGULATION IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES. THERE WAS NO REPORTED PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861325 ↗
• MalfunctionJun 13, 2023Premature Separation; Premature Separation

  THIS REPORT IS RELATED TO THE PREMATURE SEPARATION THAT OCCURRED DURING THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2023, A 40MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. PRIOR TO THE PROCEDURE, THE SEPTAL DEFECT WAS MEASURED TO BE 39MM AND IT WAS NOTED THAT THE PATIENT HAD A COMPLEX SEPTUM ANATOMY. THE DEVICE WAS ATTEMPTED TO IMPLANT IN THE DEFECT, BUT DIFFICULTY WAS ENCOUNTERED DUE TO PATIENT ANATOMY. THE DEVICE WAS DEPLOYED AND RECAPTURED MULTIPLE TIMES. DURING THESE MANIPULATIONS, THE DEVICE DETACHED FROM THE DELIVERY CABLE AND EMBOLIZED TO THE RIGHT VENTRICULAR OUTFLOW TRACT. THE DEVICE WAS SNARED AND ATTEMPTED TO RECAPTURE INTO A 16F INTRODUCER, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WENT TO EMERGENCY SURGERY, THE DEVICE WAS REMOVED, AND THE SEPTAL DEFECT WAS REPAIRED. THE PATIENT WAS DISCHARGED. RELATED MANUFACTURER REFERENCE NUMBER: 2135147-2023-00998 RELATED TO THE EMBOLIZATION OF THE 40MM AMPLATZER SEPTAL OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122244 ↗
• MalfunctionJun 2, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12F TREVISIO DELIVERY SYSTEM WAS SELECTED TO IMPLANT A 32 MM AMPLATZER SEPTAL OCCLUDER. DURING THE PROCEDURE, THE DEVICE WAS COMPLETELY RELEASED FROM THE CABLE WHILE NOT INTENDED, DEPLOYING THE DEVICE PREMATURELY IN THE LEFT ATRIUM. IT NEEDED TO BE SNARED AND REMOVED FROM THE PATIENT. THE PHYSICIAN ALLEGED THAT OVER TORQUEING OF THE DELIVERY CATHETER TO SET THE SEPTAL OCCLUDER INTO POSITION CAUSED THE DELIVERY CABLE TO UNSCREW FROM THE DEVICE PREMATURELY. THERE WAS NO DEVICE IMPLANTED. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056229 ↗
• InjuryAug 9, 2022Positioning Problem; Positioning Problem

  THIS IS BEING FILED TO REPORT THE PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A PATIENT DEATH WAS REPORTED BUT IS RELATED TO THE PATIENT'S HEALTH CONDITION PRIOR TO THE IMPLANT THAT OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT REQUIRED POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD) OCCLUSION. THE PATIENT WAS ADMITTED ON THE (B)(6) 2022 FOR AN MYOCARDIAL INFARCTION (MI). IT WAS DISCOVERED THAT THE MI CAUSED A SIGNIFICANT VSD. THE PATIENT WAS NOT A SURGICAL CANDIDATE DUE TO THEIR POOR CHANCE SURGICAL SURVIVAL. IT WAS DECIDED TO IMPLANT A 24MM AMPLATZER MUSCULAR VSD OCCLUDER. THE PATIENT RECEIVED HEPARIN AND ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED ABOVE 250 SECONDS BY ANESTHESIA. FEMORAL ACCESS WAS OBTAINED. IT WAS DECIDED TO IMPLANT THE DEVICE FROM THE RIGHT VENTRICLE. USING A NON-ABBOTT GUIDEWIRE A RAIL WAS CREATED FOR IMPROVED SUPPORT AND DEVICE DELIVERY. THE 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS PREPARED AS PER INSTRUCTION FOR USE (IFU) AND BROUGHT UP THE RAIL, INTO THE RIGHT ATRIUM, ACROSS TRICUSPID VALVE INTO THE RIGHT VENTRICLE, BUT COULD NOT CROSS THE VSD DUE TO SLACK IN THE RAIL. THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED. A UNKNOWN STIFFE

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 15194761 ↗