Amplatzer™ Talisman™ 9-PFO-3025Recalls & reported problems

Summary

The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 05415067033321), received between Jan 12, 2022 and Sep 25, 2026 — classified as 1 death, 50 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (137 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 193 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903204 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903154 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902419 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50848511 ↗
• MalfunctionSep 21, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848509 ↗
• InjurySep 17, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant. During the procedure, Heparin was administered and the patient's activated clotting time (ACT) was reported to be just below 250 seconds. Intracardiac echocardiography (ICE) was used for imaging guidance. Prior to device release, an acute, soft thrombus was observed on the distal cable. The thrombus was captured and pulled back with the device, and the device was subsequently removed. At the time of the procedure, no known hematologic disorder or systemic illness contributing to hypercoagulability had been identified, although a hematology workup was initiated. The procedure was aborted to allow for further hematologic evaluation. The patient remained stable and was subsequently discharged.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50801575 ↗
• MalfunctionAug 28, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6)2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant using a 9F Amplatzer Talisman Delivery Sheath. During device positioning within the patient, it was observed that the right atrial disc appeared puffed up, resembling a cushion. This did not change after applying forward pressure with the delivery cable. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was interaction with only septum during deployment. A new 30-25mm Amplatzer Talisman PFO Occluder was used to complete the procedure. 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 50506548 ↗
• MalfunctionAug 28, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506434 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for an implant. During the patent foramen ovale (PFO) closure procedure, there was no reported difficulty implanting the device itself; however, the physician experienced difficulty crossing the PFO defect. To facilitate crossing, an SL1 sheath was used to support a guidewire. Multiple wire and delivery sheath exchanges were performed during attempts to cross the PFO defect. The physician successfully crossed the PFO without any signs of issues. During the procedure, heparin was administered; however, the amount was unknown. The valve was not re-sheathed more than two times. The 25 mm Amplatzer Talisman PFO Occluder was subsequently delivered and released. Following device release, all delivery sheaths and wires were removed from the patient, and the venous access site was closed. While the patient was being transferred to a transport bed, the patient was noted to be unresponsive to nursing staff and was found to have a blood pressure of approximately 60/25 mmHg. The patient was returned to the catheterization laboratory table, where a circumferential pericardial effusion was identified. A pericard

  Patient problems: Pericardial Effusion

  MAUDE report 50261814 ↗
• MalfunctionAug 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216439 ↗
• InjuryJul 31, 2026Migration or Expulsion of Device

  It was reported on 07 July 2026 that a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant using a 9F Amplatzer Talisman Delivery System. The defect was reported to be large Patent Formen Ovale (PFO) with a width of approximately 8mm and a septum primum aneurysm. Transesophageal Echocardiogram (TEE) was used during the procedure. A stability check was reported to have been performed, with no leak detected around the device. No difficulty with implantation, including multiple recaptures or repositioning, was reported, and no rhythm change occurred during the procedure. The device was successfully deployed and released. A few minutes after release, the device embolized and migrated to the ascending aorta. A transthoracic echocardiogram (TTE) reportedly identified the embolization. No partial or complete obstruction of blood flow was reported, and the patient reportedly experienced no clinical signs or symptoms associated with the event. It was reported that a percutaneous retrieval attempt was unsuccessful and was followed by surgical retrieval via vascular surgery.

  Patient problems: Embolism/Embolus

  MAUDE report 50106009 ↗
• MalfunctionMay 8, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS NOTED THAT THE DEVICE CONFORMED INTO A CUP-LIKE DEFORMATION FROM THE RIGHT ATRIAL DISC. THE PROCEDURE WAS COMPLETED USING A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER. 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 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 25129832 ↗
• MalfunctionApr 27, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant using an 9F Talisman delivery system. During the procedure , it was observed that right atrial disc of the occluder took form into bulging deformation. It was also noted that the device was not explanted. The deformed device was released from the delivery cable while inside the patient. There was no interaction with the cardiac structures during deployment and there was no angulation or kink noted in the 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 25010359 ↗
• MalfunctionApr 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE. ON INITIAL PREPARATION, THE TUOHY WOULD NOT TIGHTEN AROUND THE DELIVERY SYSTEM AND KEPT LEAKING. THE TUOHY REPLACED WITH THE OTHER ON THE COME WITH THE TREVISIO AND IT WORKED/SEALED. THEY COMPLETED THE PREPARATION OF THE 30 TALISMAN AND THEN ATTEMPTED TO INTRODUCED IT INTO THE TREVISIO SHEATH. THE DEVICE WOULD NOT PASS THROUGH THE HUB, TOOK THE DEVICE OUT REPRESSED, AND REATTEMPTED TO INTRODUCE INTO THE SHEATH. BUT STILL WOULD NOT PASS THROUGH THE HUB OF THE TREVISO SHEATH HUB. THE TREVISO SHEATH WAS REPLACED WITH A NEW 9F TREVISIO AND INSERTED THE DEVICE IT INTO THE SHEATH WITHOUT DIFFICULTY. THE DEVICE GOT DEPLOYED THE LEFT ATRIAL (LA) DISC, BUT WHEN TRYING TO DEPLOY THE RIGHT ATRIAL (RA) DISC THE DEVICE PULLED ACROSS THE SEPTUM INTO THE RA. THEY TOOK THE DEVICE OUT AND RE-PREPPED IT. THEY RE-INSERTED AND DEPLOYED WITHOUT DIFFICULTY. UPON DISC DEPLOYMENT, BOTH THE RA AND OA DISC WERE BULBOUS IN APPEARANCE. THE DEVICE WAS REPLACED WITH A NEW 30MM TALISMAN. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911125 ↗
• MalfunctionApr 14, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHEN THEY IMPLANT THE DEVICE IT BECAME WITH A ROUNG SHAPE AND THEY TRIED TO PUCH BUT THE DEVICE HAD A STRANGE SHAPE AND THE DOCTOR PREFER TO IMPLANT A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877556 ↗
• MalfunctionApr 10, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. THE OCCLUDER WAS PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE LEFT DISK OPENED NORMALLY BUT WHEN THEY OPENED THE RIGHT DISK IT FORMED LIKE A MUSHROOM. IT WAS NOT POSSIBLE TO RESHAPE THE DISK SO THEY REMOVED IT AND REPLACED IT WITH ANOTHER TALISMAN PFO 30MM WHICH WAS IMPLANTED WITHOUT ANY PROBLEMS WITH THE SAME 9F TALISMAN SHEATH. 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 THAT REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845545 ↗
• MalfunctionApr 10, 2026Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEVICE WAS INSPECTED UPON PREPARATION BY THE OPERATOR AND SCRUB PERSONNEL AND FLUSHED PER IFU, WITH NO DAMAGE, KINKS, CRACKS, LEAKS, OR OBSTRUCTIONS NOTED. THE DEVICE WAS PREPPED APPROPRIATELY, AND A WET-TO-WET CONNECTION WAS COMPLETED BEFORE ADVANCEMENT INTO THE SHEATH, AT WHICH TIME AIR WAS NOTED IN THE SYSTEM AFTER THE DEVICE ENTERED THE SHEATH, WITH A LARGE AMOUNT OF AIR OBSERVED AT THE BACK END OF THE LOADER. THE PHYSICIAN WAS INSTRUCTED TO REMOVE THE DEVICE, AFTER WHICH THE DEVICE WAS REASSEMBLED AND RE-PREPPED IN ACCORDANCE WITH THE IFU; FOLLOWING RE-PREPARATION, NO AIR WAS PRESENT AND NO ABNORMAL DRIPPING WAS NOTED, AND THE WET-TO-WET CONNECTION WAS REPEATED. UPON ADVANCEMENT OF THE DEVICE INTO THE SHEATH AGAIN, A LARGE AMOUNT OF AIR WAS AGAIN OBSERVED AT THE BACK END OF THE LOADER, PROMPTING REMOVAL OF THE DEVICE AND SELECTION OF A NEW 30-25 MM AMPLATZER TALISMAN PFO OCCLUDER. DURING PREPARATION OF THE SECOND DEVICE, AIR WAS ALSO OBSERVED AT THE BACK END OF THE LOADER; HOWEVER, THE PHYSICIAN DISCONNECTED THE LOADER FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845536 ↗
• MalfunctionApr 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2026 A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEVICE PREPARATION THE RIGHT DISC OF THE OCCLUDER TOOK ON A BULBOUS SHAPE. THE RIGHT DISC WAS ABLE TO BE FLATTENED. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE OCCLUDER, THE RIGHT DISC TOOK ON A BULBOUS SHAPE AGAIN. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND RE-PREPARED. THE OCCLUDER CONFORMED BACK TO ITS ORIGINAL SHAPE. THE OCCLUDER WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS TO 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 24792425 ↗
• MalfunctionApr 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE OPENING THE OCCLUDER, IT WAS NOTED THAT THE OCCLUDER TOOK FORM OF DONUT SHAPE AND DID NOT CONFORM TO ITS DESIRED SHAPE EVEN AFTER THE OPERATOR TOOK THE DEVICE OUT AND MANUALLY TRIED TO FIX THE DISC. ANOTHER ATTEMPT TO IMPLANT THE DEVICE WAS MADE BUT THE DISC DID NOT CONFORM TO ITS DESIRED SHAPE. THE PROCEDURE WAS COMPLETED USING A NEW REPLACEMENT DEVICE. 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 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 24780441 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F TALISMAN DELIVERY SYSTEM. DURING THE IMPLANT, THE PATIENT WAS IN SINUS RHYTHM (SINUSAL), AND HEPARIN WAS ADMINISTERED (REPORTED AS 7,200 UNITS). NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. IN (B)(6) 2026, APPROXIMATELY NINE MONTHS AFTER THE IMPLANTATION, THE PATIENT DEVELOPED CHEST PAIN, AND SUBSEQUENT EVALUATION IDENTIFIED A PERICARDIAL EFFUSION LOCATED WITHIN THE PERICARDIUM. AT THE TIME THE EFFUSION WAS DETECTED, HEPARIN WAS ADMINISTERED, AND THE PATIENT LATER UNDERWENT OPEN-HEART SURGERY INVOLVING THE AORTA AND RIGHT ATRIUM. THE OCCLUDER DEVICE WAS NOT EXPLANTED, AS ITS POSITION WAS CONSIDERED APPROPRIATE AND IT HAD BECOME ENDOTHELIALIZED. THE USER DID NOT BELIEVE THE ABBOTT DEVICE CAUSED THE PERICARDIAL EFFUSION, NOTING THAT THE DEVICE REMAINED IN PLACE. THE PERICARDIAL EFFUSION WAS RESOLVED BY OPEN-HEART SURGERY.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 24536201 ↗
• MalfunctionMar 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE USING 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, IN RIGHT ATRIUM, THE DEVICE TOOK INCORRECT BULBOUS SHAPE MULTIPLE TIMES. 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 DEVICE WAS REMOVED AND A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN. 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531537 ↗
• InjuryFeb 27, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING 9F AMPLATZER TALISMAN DELIVERY SYSTEM. THE TUNNEL DIMENSION WAS REPORTED AS 11 MM. THE SIZING OF THE DEVICE WAS DETERMINED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE), AND TOE ALONG WITH FLUOROSCOPY WERE USED AS THE IMAGING MODALITIES DURING THE PROCEDURE. THE 30¿25 MM AMPLATZER TALISMAN PFO OCCLUDER WAS IMPLANTED, AND THE TOE IMAGES WERE REVIEWED BY THE PHYSICIAN. THE DEVICE APPEARED STABLE DURING THE TUG TEST, AND NO LEAK WAS OBSERVED AROUND THE LOBE OF THE DEVICE. THERE WAS NO DIFFICULTY WITH THE IMPLANTATION, INCLUDING NO MULTIPLE RECAPTURES OR REPOSITIONING, AND NO RHYTHM CHANGE OCCURRED DURING THE PROCEDURE. DURING A ROUTINE TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED THE FOLLOWING MORNING, THE DEVICE WAS FOUND TO HAVE EMBOLIZED, AND THIS FINDING WAS ALSO IDENTIFIED ON CT IMAGING. IT WAS REPORTED THAT THE DEVICE HAD COMPLETELY DISLODGED FROM THE IMPLANT SITE AND HAD MIGRATED TO THE DISTAL AORTA AT THE LEVEL OF THE COELIAC ARTERY, WHERE IT WAS POSITIONED VERTICALLY. THE EMBOLIZED DEVICE DID NOT CAUSE PARTIAL OR COMPLETE OBSTRUCTION OF BLOOD FLOW. THE IMPLANTER BELIEVES

  Patient problems: Angina

  MAUDE report 24475443 ↗
• MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026 A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. IT WAS NOTED THAT THE OCCLUDER WAS PREPPED AND RE PREPPED MULTIPLE TIMES, BUT IT DIDN'T CONFORM TO ITS DESIRED SHAPE. THE PROCEDURE WAS COMPLETED USING A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER. 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 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 24370447 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT THE FOSSA. DURING THE CASE, MULTIPLE MANIPULATIONS AND MULTIPLE WIRE EXCHANGES OCCURRED, WITH THE WIRE POSITIONED WITHIN THE RIGHT ATRIUM. THE PATIENT WAS IN SINUS RHYTHM AT THE TIME, OF THE PROCEDURE. THE PATIENT HAD BEEN TAKING ASPIRIN (APT) PRIOR TO THE PROCEDURE AND CONTINUED ON ASPIRIN AT THE TIME THE EFFUSION WAS DETECTED. THE PATIENT ALSO RECEIVED ENOXAPARIN 0.5 MG/KG DURING THE PROCEDURE, AND NO PROTAMINE OR OTHER REVERSAL AGENTS WERE ADMINISTERED. A PERICARDIAL EFFUSION WAS SUBSEQUENTLY IDENTIFIED AND WAS LOCATED WITHIN THE PERICARDIUM, MEASURING 14 MM IN ITS LARGEST DIMENSION AND CHARACTERIZED AS CIRCUMFERENTIAL. THE EFFUSION WAS MANAGED WITH PERICARDIOCENTESIS, AND THE USER DID NOT BELIEVE THE EVENT WAS CAUSED BY AN ABBOTT DEVICE.

  Patient problems: Pericardial Effusion

  MAUDE report 24283538 ↗
• MalfunctionFeb 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE RIGHT AND LEFT DISCS OF THE OCCLUDER WAS NOT CONFORMING TO THEIR DESIRE SHAPE AND TAKE BULBOUS DEFORMATION. THE PROCEDURE WAS COMPLETED USING A 25 - 18MM AMPLATZER TALISMAN PFO OCCLUDER. 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 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 24283537 ↗