Amplatzer™ Trevisio™ 9-ATV09F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05415067030931), received between Mar 11, 2021 and Aug 28, 2026 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Fluid/Blood Leak

  It was reported on (b)(6) 2025, a 9F Amplatzer Trevisio Intravascular Delivery System was chosen for a procedure. During the device preparation, while flushing the device, it was noted that a leak was observed at the Y-connector thread. The flushing of the device was performed according to the Instructions for Use (IFU). The delivery system had been inspected prior to use, and no cracks or other abnormalities were observed. No damage to the product packaging was noted before opening, and no cracks or damage were observed on the delivery system. The device had not been handled or manipulated prior to the observation of the leakage. The reported leakage was less than 200 mL and did not result in any blood loss. Despite the leakage, the procedure was completed successfully using the same device. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505779 ↗
• MalfunctionAug 12, 2026Fluid/Blood Leak; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229620 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING DEVICE PREPARATION AND FLUSHING PERFORMED IN ACCORDANCE WITH THE IFU, IT WAS NOTED THAT THE DELIVERY SHEATH AND TOUHY WERE LEAKING, WITH A CONSTANT SALINE LEAK OBSERVED DURING FLUSHING. AIR WAS ALSO NOTED WITHIN THE SYSTEM DURING THE DE-AIRING PROCESS, WHICH MADE PREPARATION CHALLENGING. THE DEVICE WAS INSPECTED PRIOR TO USE, NO CRACK, DAMAGE, OR ABNORMALITIES WERE NOTED, AND THERE WAS NO DAMAGE OBSERVED TO THE PRODUCT PACKAGING PRIOR TO OPENING. THE DEVICE DID NOT INITIALLY COME IN DIRECT CONTACT WITH THE PATIENT; HOWEVER, A FLUSH BAG OF SALINE WAS ATTACHED TO THE SHEATH TO PROVIDE FORWARD PRESSURE AND PREVENT FURTHER AIR INGRESS, AFTER WHICH BLOOD LEAKAGE WAS OBSERVED WHEN THE SYSTEM WAS CONNECTED TO THE PATIENT. THE LEAKAGE WAS DESCRIBED AS A CONTINUOUS DRIP, NOT EXCEEDING 200 ML, AND NO CLINICALLY SIGNIFICANT BLOOD LOSS OCCURRED. NO DAMAGED COMPONENTS OR CRACKS WERE IDENTIFIED IN THE DELIVERY SYSTEM. THE DEVICE WAS SUBSEQUENTLY RESIZED AND EXCHANGED, AND THE PROCEDURE WAS COMPLETED USING A NEW TALISMAN DEVICE, WITH THE TALISMAN DELIVERY WIRE AND TOUHY USED IN PLACE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010358 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR THE PROCEDURE. DURING DEVICE PREPARATION, IT WAS NOTED THAT THE THERE WAS A LEAK OBSERVED AT THE LEVEL OF THE STOPCOCK. THE LEAK WAS NOTED TO BE SALINE WHICH WAS USED FOR FLUSHING. THERE WAS NO DAMAGE OBSERVED ON THE PRODUCT PACKAGING. IT WAS ALSO REPORTED THAT THE STOPCOCK SCREW THREAD APPEARED DAMAGED WHICH LED TO THE LEAK AT THE LEVEL OF THE STOPCOCK. THERE WAS NO CRACK OR MATERIAL DEFORMATION OBSERVED. THE PROCEDURE WAS COMPLETED USING A NEW 8F AMPLATZER TREVISIO DELIVERY SYSTEM. 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 24718765 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING DEVICE PREPARATION, THE DEVICE WAS INSPECTED WITH NO CRACK NOTED AT THAT TIME. WHILE FLUSHING THE SIDE ARM IN ACCORDANCE WITH THE IFU, A LEAK WAS OBSERVED FROM THE SIDE ARM, AND A CRACK AT THE CONNECTION WAS SUBSEQUENTLY IDENTIFIED AT THE TIME, OF FLUSHING. THE LEAK OCCURRED DURING THE FIRST 30 ML SYRINGE FLUSH, WITH APPROXIMATELY 15 ML INFUSED WHEN THE LEAK WAS NOTED. NO HANDLING OR MANIPULATION BEYOND STANDARD PREPARATION OCCURRED PRIOR TO THE OBSERVATION, AND NO ADDITIONAL COMPONENTS OF THE DELIVERY SYSTEM WERE OBSERVED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A 9F AMPLATZER TORQVUE EXCHANGE SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY OR ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651801 ↗
• InjuryDec 30, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE INITIAL PREPARATION OF THE PFO OCCLUDER DEVICE WAS PERFORMED CORRECTLY, ENSURING ALL AIR WAS REMOVED FROM THE LOADER AND SYSTEM. ONCE THE DEVICE WAS ATTACHED AND INSERTED INTO THE DELIVERY SYSTEM AND ADVANCED APPROXIMATELY HALFWAY THROUGH THE SHEATH, THE PATIENT EXHIBITED ST ELEVATIONS DUE TO AN AIR EMBOLISM. THE PHYSICIAN RETRACTED THE DEVICE BACK INTO THE LOADER, DETACHED IT, AND REMOVED IT FROM THE PATIENT. ON THE BACK TABLE, WHILE ATTEMPTING TO FLUSH AND RE-PREPARE THE DEVICE, THE TUOHY ATTACHED TO THE LOADER DID NOT FULLY SEAL. THE TECHNICIAN ATTEMPTED TO TROUBLESHOOT THE TUOHY TIGHTNESS; HOWEVER, EVEN WHEN TIGHTENED AS MUCH AS POSSIBLE, THE TUOHY CONTINUED TO LEAK SALINE. THE PROCEDURE WAS COMPLETED USING A NEW 30¿25 MM AMPLATZER TALISMAN PFO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, AND NO ADVERSE EFFECTS WERE OBSERVED.

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

  MAUDE report 23927239 ↗
• MalfunctionNov 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660523 ↗
• MalfunctionNov 25, 2025Retraction Problem; Retraction Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649423 ↗
• MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2025 A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, WHILE PUSHING THE DELIVERY SYSTEM OVER THE NON-ABBOTT GUIDEWIRE, THE TIP OF THE DILATOR SPLIT. THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DELIVERY SYSTEM DID NOT MAKE CONTACT WITH THE PATIENT. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS TO THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646865 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8F AND 9F AMPLATZER TREVISIO DELIVERY SYSTEMS WERE SELECTED FOR A PROCEDURE. DURING PROCEDURE ISSUES WERE OBSERVED SEQUENTIALLY WITH BOTH SYSTEMS. THE EXTENSION TUBING WERE SPRAYING AND LEAKING BELOW THE LOCKS. SPECIFICALLY, THE EXTENSION TUBING ON EACH SYSTEM EXHIBITED LEAKAGE IN THE FORM OF A SALINE SPRAY, WITH AN ESTIMATED VOLUME OF APPROXIMATELY 20 ML. BOTH DELIVERY SYSTEMS ENTERED THE PATIENT'S ANATOMY. IT WAS REPORTED THAT THEY WERE CONSIDERED AS THE ISSUE. THE EXTENSION TUBING WAS REPORTED TO BE THE ONE WITH THE ISSUE. NO VISIBLE DAMAGE WAS NOTED ON THE TUBING OR OTHER COMPONENTS. A PRE-USE INSPECTION OF BOTH DELIVERY SYSTEMS WAS PERFORMED, AND NO ABNORMALITIES WERE IDENTIFIED AT THAT TIMETHE PROCEDURE WAS COMPLETED USING A 12 F AMPLATZER TREVISIO DELIVERY SYSTEM. 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 23570366 ↗
• MalfunctionSep 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEFECT BEING TREATED WAS CONFIRMED TO BE AN ATRIAL SEPTAL DEFECT. IT WAS NOTED THAT DURING THE PREPARATION OUTSIDE THE BODY, THE OCCLUDER TRANSFORMED INTO A COBRA HEAD. IT IS REPORTED THAT THE DELIVERY SYSTEM AND THE OCCLUDER MADE CONTACT WITH THE PATIENT THERE WAS NO CONTACT WITH THE INTRACARDIAC TISSUE DURING DEPLOYMENT OR NO BEND OR KINK WAS OBSERVED IN THE DELIVERY SHEATH. IT IS NOTED THAT DEFORMED DEVICE WAS RETRIEVED BEFORE IT WAS RELEASED FROM THE DELIVERY CABLE AND THERE WAS NO HARM TO THE PATIENT. A NEW REPLACEMENT 18MM AMPLATZER SEPTAL OCCLUDER WITH 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059849 ↗
• MalfunctionAug 15, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM (DS). DURING THE PROCEDURE, IT WAS NOTED THAT THE FRONT END OF THE DS WAS OUT OF SHAPE AND WAS BLOCKED MAKING IT UNABLE TO RELEASE THE OCCLUDER. THE DS WAS REPLACED TO RESOLVE THE EVENT. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819410 ↗
• InjuryJun 27, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS SELECTED FOR A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE. THE PATIENT WAS UNDER CONSCIOUS SEDATION FOR PROCEDURE. A STANDARD NON-ABBOTT GUIDEWIRE AND SOFT NON-ABBOTT J GUIDEWIRE WERE PLACED INTO THE UPPER PULMONARY VEIN. IT WAS NOTED ON A 12 LEAD ELECTROCARDIOGRAM AFTER EXCHANGING FOR THE DELIVERY SYSTEM, THAT THE PATIENT HAD AN ST ELEVATION. ASPIRATION WAS ATTEMPTED WITH A SYRINGE ON THE LEUR LOCK OF THE 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT'S HIGHLY SUSPECTED THAT THERE WAS AIR INGRESS FROM THE 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WAS NOT A CONTINUOUS FLUSH ATTACHED. THE DILATOR AND GUIDEWIRES WERE NOT REMOVED TOO QUICKLY OR TOO SLOWLY. THE LOADER WAS NOT IMMEDIATELY CONNECTED TO THE DELIVERY SYSTEM AFTER THE REMOVAL OF THE DILATOR OR GUIDEWIRE. IT WAS ALSO NOTED THAT PATIENT WAS SNORING THROUGHOUT THE PROCEDURE. THE PATIENT HAD CARDIOPULMONARY RESUSCITATION PERFORMED FOR 30 SECONDS, WAS PLACED ON HIGH FLOW OXYGEN, AND ADMINISTERED UNKNOWN MEDICATION. THE PROCEDURE WAS ABORTED. THE PATIENT DID HAVE A PROLONGED HOSPITALIZATION DUE TO THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22350418 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT THE PATENT FORAMEN OVALE (PFO). THE PATIENT STATUS WAS IN SINUS RHYTHM. TRANSSEPTAL ACCESS WAS THROUGH THE PFO. DURING THE PROCEDURE A CIRCUMFERENTIAL PERICARDIAL EFFUSION, WHICH DEVELOPED INTO A CARDIAC TAMPONADE, WAS NOTED IN THE LEFT ATRIUM ON THE RIGHT SIDE NEAR THE SUPERIOR VENA CAVA (SVC) WHILE MANIPULATING THE DELIVERY SYSTEM ACROSS THE SEPTUM. A SMALL NICK WAS NOTED ON THE END OF THE LEFT ATRIAL APPENDAGE (LAA). THE OCCLUDER WAS PARTIALLY RE-CAPTURED ONCE. THE OCCLUDER WAS IMPLANTED. THE PERICARDIAL EFFUSION DEVELOPED INTO A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE NICK WAS SURGICALLY REPAIRED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 22195886 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2024, AN 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS SELECTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED THAT THERE WAS NO PERFORMANCE ISSUES WITH THE DELIVERY SYSTEM. POST-PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A RIGHT INGUINAL HEMATOMA AT THE ACCESS OF THE DELIVERY SYSTEM. THE HEMATOMA RESOLVED WITH MANUAL COMPRESSION AND THE PATIENT DID NOT REQUIRE A TRANSFUSION. THE CAUSE OF THE PATIENT'S RIGHT INGUINAL HEMATOMA IS ATTRIBUTED TO SUBOPTIMAL PUNCTURE SITE COMPRESSION. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Hematoma

  MAUDE report 21509967 ↗
• MalfunctionDec 5, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9F AMPLATZER TREVISIO DELIVERY SYSTEM (DS) WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. WHILE THE DS WAS BEING INSERTED OVER THE WIRE INTO THE VESSEL, THE PASSAGE OF THE DS WAS IMPEDED. THE DS WAS REMOVED AND IT WAS NOTED THAT THE TIP HAD BECAME BURRED. IT WAS REPLACED WITH A 10F AMPLATZER TREVISIO DS TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854608 ↗
• MalfunctionMay 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM FOR A PATENT FORAMEN OVALE (PFO) CLOSURE. THE DELIVERY SYSTEM WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). THE OCCLUDER WAS ATTACHED TO THE DELIVERY CABLE. THE DELIVERY SHEATH AND DILATOR WERE INSERTED ACROSS THE PFO. THE WIRE AND DILATOR WERE REMOVED. THE DEVICE WAS ABOUT TO BE FLUSHED WHEN IT WAS NOTED THAT THE BLUE STOPCOCK LEVER WAS OUT OF THE STOPCOCK. THE LUER WAS QUICKLY EXCHANGED FOR A 3-WAY STOPCOCK. THE DEVICE WAS FLUSHED WITH 60CC OF STERILE SALINE TO ENSURE THAT THE DEVICE WAS AIR FREE PRIOR TO WET TO WET CONNECTION. NO AIR WAS SEEN IN THE DEVICE OR IN THE PATIENT. THE REMAINDER OF THE CASE WAS PERFORMED SUCCESSFULLY WITHOUT INCIDENT. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19394249 ↗
• MalfunctionJul 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT, USING 09F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT OF THE DEVICE, THE LEFT ATRIAL DISK DEFORMED. THE DEVICE WAS RECAPTURED AND REMOVED. THE TIP OF THE DELIVERY SYSTEM WAS NOTED TO BE DEFORMED. A REPLACEMENT 09F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM AND OCCLUDER WERE USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS SUCCESSFULLY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342287 ↗
• MalfunctionMay 10, 2023Premature Separation; Premature Separation

  IT WAS REPORTED ON (B)(6) 2023, A 30MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT. SIZING OF THE DEVICE WAS DETERMINED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND IT WAS REPORTED THE SHORTEST DISTANCE FROM PATIENT DEFECT TO THE AORTIC ROOT WAS 16.4MM. DURING PROCEDURE, IT WAS REPORTED THE DEVICE HAD PRE-RELEASED FROM THE DELIVERY CABLE AND EMBOLIZED IN THE RIGHT ATRIUM THROUGH TO THE RIGHT VENTRICLE TOWARDS THE APEX. IT WAS REPORTED THERE WAS NO PARTIAL OR COMPLETE OBSTRUCTION OF BLOOD FLOW CAUSED BY THE DEVICE. AN ATTEMPT WAS MADE TO SNARE THE DEVICE BUT WAS UNSUCCESSFUL. A DECISION WAS MADE TO TRANSFER THE PATIENT FOR OPEN HEART SURGERY IMMEDIATELY AND THE DEVICE WAS REMOVED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THEIR STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900379 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS SELECTED FOR A PFO CLOSURE PROCEDURE. DURING THE PROCEDURE, WHILE THE DELIVERY SYSTEM WAS IN THE LEFT ATRIUM, IT WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THERE WAS AIR BUBBLES IN THE LEFT ATRIUM. THE PATIENTS ELECTROCARDIOGRAM (EKG) HAD ABNORMAL READINGS. A CORONAROGRAPHY WAS PERFORMED SHOWING AIR IN THE CORONARY ARTERY. THE PATIENT SUBSEQUENTLY DEVELOPED CARDIAC ARREST. THE PATIENT WAS THEN STABILIZED.

  Patient problems: Cardiac Arrest

  MAUDE report 16130901 ↗
• InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD BEEN EXPERIENCING NUMBNESS AND TINGLING ON UPPER THIGH. A DUPLEX ULTRASOUND WAS DONE AND THE PATIENT WAS ADMITTED INTO THE HOSPITAL. VASCULAR SURGEON PERFORMED ANOTHER ULTRASOUND AND IT CONFIRMED A 1CM PSEUDOANEURYSM. SURGICAL INTERVENTION WAS NOT NEEDED. PATIENT STABLE.

  Patient problems: Pseudoaneurysm

  MAUDE report 14903388 ↗
• MalfunctionJun 14, 2022Break

  EARLY 80¿S FEMALE WITH HISTORY OF ATRIAL SEPTAL DEFECT. PROCEDURE: ATRIAL SEPTAL DEFECT CLOSURE. DURING THE PROCEDURE, THE SHEATH DILATOR HUB BROKE OFF IN THE SHEATH HUB, MAKING IT SO THE DEVICE COULD NOT FIT THROUGH. PRODUCTS REMOVED WITHOUT KNOWN HARM TO PATIENT- OTHER REPLACEMENT PRODUCTS USED SUCCESSFULLY. MANUFACTURER RESPONSE FOR CATHETER, PERCUTANEOUS, AMPLATZER¿ TREVISIO¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684386 ↗
• InjuryNov 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2021, A 9 F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM WAS BEING USED FOR A PFO-OCCLUSION PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS PREPARED AND THE DELIVERY SYSTEM WAS INTRODUCED INTO PATIENTS LEFT ATRIUM. THE AMPLATZER PFO OCCLUDER WAS THEN INTRODUCED THROUGH THE DELIVERY SYSTEM AND PUSHED FORWARD, WHILE THE LEFT ATRIAL DISC WAS ENFOLDED IN THE LEFT ATRIUM THE PATIENT STARTED TO BECOME HEMODYNAMICALLY UNSTABLE (HYPOTENSION, BRADYCARDIA) WITH AN ST ELEVATION SEEN ON ECG. A CORONARY ANGIOGRAPHY WAS PERFORMED AND SMALL AIR BUBBLES WERE NOTED IN THE RIGHT CORONARY ARTERY (RCA) WAS SEEN. CATECHOLAMINES AND ADRENALINE WERE ADMINISTERED DUE TO THE HEMODYNAMIC INSTABILITY AND THE RCA WAS FLUSHED TO REMOVE THE AIR BUBBLES. AFTER THE PATIENT WAS STABILIZED, THE PROCEDURE WAS CONTINUED. THE DELIVERY SYSTEM AND OCCLUDER WERE REPLACED FOR ANOTHER DELIVERY SYSTEM AND OCCLUDER AND THE IMPLANTATION WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS EXTENDED LONGER THAN IS CLINICALLY SIGNIFICANT. THE PATIENT IS STABLE. THE PHYSICIAN STATED THAT DURING THE DEVICE PREPARATION, THE AMPLATZER PFO OCCLUDER MAY NOT HAVE BEEN FULLY DE-AIRED (MAYBE A FEW BUBBLES ST

  Patient problems: Air Embolism; Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 12847873 ↗
• InjuryAug 13, 2021Biocompatibility; Biocompatibility

  RELATED MANUFACTURING REFERENCE NUMBER: 2135147-2021-00320. IT WAS REPORTED THAT AN 18MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT IN THE PATIENT ON (B)(6) 2021. THE PATIENT WAS PRESCRIBED THE ANTICOAGULANT HEPARIN AND WAS REPORTED TO BE IN COMPLIANCE WITH THE MEDICATION. THE PHYSICIAN PERFORMED THE PROCEDURE STEP BY STEP AND USED A 9F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM TOGETHER WITH A 002 AMPLATZER GUIDEWIRE. THE SYSTEM WAS INTRODUCED INTO THE PATIENT AND AT THE MOMENT OF POSITIONING THE SHEATH TO RELEASE THE PROSTHESIS, IT WAS NOTED WHEN ANALYZING THE ECHOCARDIOGRAM AND SCOPY IMAGES THAT THERE WAS A THROMBUS. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND IT WAS VERIFIED THAT THERE WAS A THROMBUS THROUGH THE SYSTEM. THE PHYSICIAN REPLACED THE DELIVERY SYSTEM WITH A 10F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM, REPLACED THE GUIDEWIRE WITH ANOTHER 002 AMPLATZER GUIDEWIRE AND SELECTED A 19MM AMPLATZER SEPTAL OCCLUDER FOR IMPLANT. THE 19MM AMPLATZER SEPTAL OCCLUDER WAS PLACED WITHOUT COMPLICATION UNTIL THE END OF THE PROCEDURE IN HEMODYNAMICS. THERE IS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INF

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12319621 ↗
• InjuryMar 11, 2021Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  ON (B)(6) 2021, A 18MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING PLACEMENT, IT WAS DEEMED TOO SMALL. WHILE ATTEMPTING TO RE SHEATH THE 18MM AMPLATZER CRIBRIFORM OCCLUDER THE DEVICE WOULD NOT ENTER DESPITE STRONG FORCE. IT WAS THOUGHT THAT THE DISTAL TIP OF THE AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM SHEATH SOMEHOW FOLDED-IN ON ITSELF CAUSING ISSUES WITH RETRIEVING THE DEVICE. THE HOSPITAL HAD NO EXCHANGE DELIVERY SYSTEM SO THE PHYSICIAN CUT THE TAPERED END OF THE DILATOR IN ORDER TO PASS IT OVER THE DELIVERY CABLE AND STRAIGHTEN THE DISTAL TIP OF THE SHEATH, HOWEVER, THEY COULD NOT GET THE CUT DILATOR OVER THE DELIVERY CABLE. IT WAS THEN DECIDED TO USE A 6F DELIVERY SHEATH TO PUSH OUT THE TIP OF THE 9F DELIVERY SHEATH. THE 9F SHEATH WAS CUT TO REMOVE ENOUGH OF THE PROXIMAL END TO ALLOW THE 6F SHEATH TO REACH THE END. THIS STRATEGY WORKED AND THE DEVICE WAS RECAPTURED WITHOUT ISSUE. THE DEVICE WAS INSPECTED AND PROFILE THE RIGHT DISC APPEARED OVAL INSTEAD OF FLATTENED. A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS SIGNIFICANTLY DELAYED BECAUSE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466350 ↗