Amplatzer™ PFO Occluder (REF 9-PFO-018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00811806011271), received between Dec 17, 2019 and Mar 2, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 18MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR A PROCEDURE USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE DO NOT TAKE PROPER 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 AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM THE PROCEDURE GOT ABORTED. 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 24482946 ↗
• MalfunctionOct 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18 MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9 F AMPLATZERTORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT, IT WAS OBSERVED THAT THE DEVICE WAS NOT TAKING THE PROPER SHAPE, THE RIGHT DISC OF THE DEVICE WAS BULGING AND NOT CONFORMING TO THE SEPTUM. SO, THE PHYSICIAN HAD TO REMOVED THE DEVICE AND THE PROCEDURE WAS ABORTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTIONS WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. IT WAS ALSO REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352791 ↗
• MalfunctionOct 4, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, THE RIGHT DISC HAD A BULBOUS DEFORMATION. THE PHYSICIAN TRIED THREE TIMES, BUT IT DIDN'T WORK. 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. A NEW 4MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. 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 AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871030 ↗
• InjuryJul 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT ON AN ATRIAL SEPTAL DEFECT (ASD) USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT HAD A COMPLEX ANATOMY DUE TO A CONGENITAL MALFORMATION OF CARDIAC CHAMBERS AND CONNECTIONS. THE 12MM AMPLATZER SEPTAL OCCLUDER WAS ATTEMPTED TO BE PLACED, BUT THE DEVICE DID NOT PROVIDE A COMPLETE CLOSURE, SO IT WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ALLEGATION AGAINST THE SIZING OF THE 12MM AMPLATZER SEPTAL OCCLUDER. NEXT, A 6MM BY 6MM AMPLATZER DUCT OCCLUDER II WAS CHOSEN TO MINIMIZE THE INTERACTION OF THE DISC WITH THE ATRIAL WALL. THE RESULT WAS UNSATISFACTORY WITH INCOMPLETE CLOSURE, SO IT WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ALLEGATION AGAINST THE SIZING OF THE 6MM BY 6MM AMPLATZER DUCT OCCLUDER II. THEN, A 18MM AMPLATZER PFO OCCLUDER WAS DEPLOYED AND RELEASED. DUE TO THE COMPLEX ANATOMY, THE DEVICE DID NOT SIT AS EXPECTED ON THE SEPTUM UPON RELEASE, AND CLOSURE WAS NOT COMPLETELY ACHIEVED. THE EXACT ORIGIN OF THE LEAK COULD NOT BE DETERMINED. THE DEVICE WAS SUCCESSFULLY SNARED AND RETRIEVED FROM THE PATIENT. A 20MM NON-AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282513 ↗
• MalfunctionMar 15, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT IT APPEARED AS THOUGH A THROMBUS HAD ADHERED TO THE OCCLUDER. THE OCCLUDER WAS FULLY REMOVED AND IT WAS DETERMINED THAT AN EXPOSED THREAD WAS COMING OUT OF THE OCCLUDER. THE 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS NOT DAMAGED OR MISHANDLED AT ANY POINT DURING DEVICE PREPARATION. THE OCCLUDER HAD BEEN SIZED USING AN UNKNOWN 24MM SIZING BALLOON. THERE WAS NO THROMBUS CONFIRMED. THE PATIENT DOES NOT HAVE ANY HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY. THE PATIENT RECEIVE ANY TREATMENT (MEDICATIONS) THAT COULD CONTRIBUTE TO THROMBUS FORMATION. IT WAS NOTED THAT THE OCCLUDER WAS RETRACTED FULLY/COMPLETELY INTO THE DELIVERY SYSTEM PRIOR TO NOTING THE EXPOSED THREAD. THE DECISION WAS MADE TO 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548213 ↗
• MalfunctionFeb 27, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 18MM AMPLATZER PFO WAS SELECTED FOR IMPLANT USING A NON- ABBOTT SHEATH/DELIVERY SYSTEM THAT WAS AVAILABLE. THE LEFT ATRIAL DISC WOULD DEPLOY AND THEN THERE WAS DIFFICULTY IN DEPLOYING THE RIGHT ATRIAL DISC. IT APPEARED BULBOUS IN SHAPE AND AFTER MULTIPLE DEPLOYMENTS, THE DEVICE WAS REMOVED FROM THE PATIENT FOR INSPECTION. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND THERE WAS NO ANGULATION/KINK OBSERVED WITH THE DELIVERY SYSTEM. IT WAS REPORTED THAT THERE WAS INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. A 25MM AMPLATZER PFO WAS SELECTED AND SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448774 ↗
• MalfunctionJan 6, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 18MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANTATION USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, THE RIGHT DISC DEFORMED INTO A BULGING SHAPE. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY AND REPLACED WITH ANOTHER 18MM AMPLATZER PFO OCCLUDER. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY; THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT WAS REPORTED TO BE STABLE AND DISCHARGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117981 ↗
• MalfunctionNov 19, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING DEVICE PREPARATION AND PRIOR TO INTRODUCING THE OCCLUDER INTO THE UNKNOWN ABBOTT DELIVERY SYSTEM, A PROTRUDING THREAD ON THE OCCLUDER SEEN AROUND THE DISK AREA. THE PROTRUDING THREAD WAS NOT CONSIDERED ACCEPTABLE DUE TO THE THE POSSIBILITY FOR EMBOLIZING IF IMPLANTED. THE DECISION WAS MADE TO CUT OUT THE PROTRUDING THREAD AND IMPLANT THE 18MM AMPLATZER PFO OCCLUDER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830847 ↗
• MalfunctionAug 8, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 18MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING DEPLOYMENT THERE WAS BULGING RIGHT ATRIAL DISC, PREVENTING CORRECT APPOSITION TO THE SEPTUM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE OCCLUDER WAS EXCHANGED FOR A NEW 18MM AMPLATZER PFO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGH THE PROCEDURE AND NO CLINICAL SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188707 ↗
• MalfunctionJul 28, 2022Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion; Difficult to Fold, Unfold or Collapse; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2022 , A 18MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR PROCEDURE. DURING DEVICE PREPARTION, THE AMPLATZER PFO OCCLUDER WAS NOTED TO HAVE AN EXPOSED THREAD. THE DECISION WAS MADE TO CUT OFF THE THREAD AND TO CONTINUE TO THE 18MM AMPLATZER PFO OCCLUDER FOR IMPLANT. DURING PROCEDURE, BOTH DISCS OF THE OCCLUDER EXHIBITED A BALL SHAPE WITHOUT RESOLUTION. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM A SECOND 18MM AMPLATZER PFO OCCLUDER WAS USED AS A REPLACEMENT DEVICE AND IMPLANTED SUCCESSFULLY. 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 15126395 ↗
• MalfunctionDec 16, 2021Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, AN 18 MM AMPLATZER PFO OCCLUDER, ALONG WITH AN 8 F AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM, WAS CHOSEN FOR A PFO CLOSURE PROCEDURE. DURING PROCEDURE, THE RIGHT ATRIAL PROXIMAL DISC WAS UNABLE TO OPEN, AND THE SHAPE OF THE DISC WAS LIKE AN ELLIPSE. THE DEVICE WAS TAKEN OUT OF THE PATIENT AND TESTED OUTSIDE OF THE BODY AND WAS ABLE TO OPEN NORMALLY. HOWEVER, DURING RE-IMPLANTATION, IT DID NOT OPEN CORRECTLY IN THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 18 MM AMPLATZER PFO OCCLUDER TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023323 ↗
• MalfunctionOct 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, AN 18 MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE RIGHT DISC OF THE DEVICE WAS DEFORMED AND LOOKED LIKE A TIRE AFTER BEING DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT. A 25 MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12690316 ↗
• MalfunctionNov 25, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6), 2019 A 18MM AMPLATZER PFO OCCLUDER WAS IMPLANTED. ON (B)(6), 2020, DEVICE MIGRATION WAS OBSERVED AND ON AN UNKNOWN DATE, THE OCCLUDER WAS EXPLANTED. THE PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IS UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900193 ↗
• InjuryNov 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2019 A 18MM AMPLATZER PFO OCCLUDER WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS ADMITTED FOR ABDOMINAL PAIN AND GI BLEEDING. UPON IMAGING, IT WAS FOUND THAT THE DEVICE MIGRATED TO THE DISTAL AORTA. THE DEVICE REMAINED IMPLANTED. IN ADDITION, IMAGING ALSO SUBSEQUENTLY FOUND MULTIPLE DEEP VEIN THROMBOSIS'S (DVT), HOWEVER THE PHYSICIAN DOES NOT ALLEGE A RELATIONSHIP BETWEEN THE MULTIPLE DVT'S AND THE MIGRATED OCCLUDER. THE PATIENT IS STABLE AND DISCHARGED.

  Patient problems: Abdominal Pain; Thrombosis

  MAUDE report 10897487 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ON (B)(6) 2020 AN AMPLATZER OCCLUDER WAS IMPLANTED IN A (B)(6) FEMALE. PULMONARY EMBOLISM WAS FOUND AS PATIENT WAS BEING EVALUATED FOR STROKE AT HOSPITAL. NO INFORMATION FOR SHUNT DURING DISCHARGE. DURING FOLLOW UP - NO SYMPTOM OF STROKE WHEN THE PATIENT WAS INTERVIEWED. AT 12 MONTH (IN JUNE), TEE SHOWED MILD RESIDULA SHUNT, BUT NO THROMBUS. SURGICAL INTERVENTION WAS PERFORMED FOR THE STROKE, PULMONARY EMBOLISM, AND DEEP VEIN THROMBOSIS. VENTILATOR DEPENDENT RESPIRATORY FAILURE ON (B)(6) 2020, LEFT ANTERIOR FASCICULAR BLOCK SEPTAL MYOCARDIAL INFARCTION. PATIENT WAS ADMITTED FOR STROKE AND PULMONARY EMBOLISM AND DVT. SURGICAL INTERVENTION WAS PERFORMED.

  Patient problems: Pulmonary Embolism

  MAUDE report 10471329 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 AN AMPATZER PFO WAS SELECTED FOR A PROCEDURE. AFTER OPENING THE DISTAL DISC IN THE LEFT ATRIUM, IT WAS NOTATED THAT THE LEFT ATRIAL DISC WAS CUPPED. HE ATTEMPTED TO FLATTEN IT WHILE GENTLY NUDGING THE DEVICE AGAINST THE BACK OF THE LEFT ATRIUM, BUT IT WOULD NOT FLATTEN OUT. GIVEN THIS APPEARANCE, HE DECIDED TO RECAPTURE THE DEVICE AND INSPECT IT. AFTER THE DEVICE WAS REMOVED FROM THE BODY THE LEFT DISC RETAINED A VERY CUPPED SHAPE. HE THAN DECIDED TO OPEN A 25MM PFO OCCLUDER, WHICH WAS PLACED SUCCESSFULLY WITH NO FURTHER ISSUES. BOTH DEVICES WERE DELIVERED THROUGH AN 8FR TREVISIO. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. THERE WERE NO COMPLICATIONS IN THE PROCEDURES. THE PATIENT WAS DISCHARGED THE SAME DAY PER THE ROUTINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10438962 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020 A 18MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR PROCEDURE FOR PFO CLOSURE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL DISC WAS DOME SHAPED AND WOULD NOT FLATTEN OUT. GIVEN THIS APPEARANCE, IT WAS DECIDED TO RECAPTURE THE DEVICE AND INSPECT IT ON TABLE TOP. THE DEVICE WAS REMOVED FROM THE BODY AND STILL RETAINED A VERY DOMED SHAPE. THE DEVICE WAS MANUALLY FLATTENED OUT, BUT RESUMED THE DOME SHAPED APPEARANCE WHEN A TEST DEPLOYMENT WAS PERFORMED ON TABLE TOP. ANOTHER 18MM PFO OCCLUDER (LOT# 7262194) WAS CHOSEN AND PLACED SUCCESSFULLY WITH NO FURTHER ISSUES OR COMPLICATION REPORTED, PATIENT DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335006 ↗
• InjuryDec 17, 2019Material Deformation; Material Deformation

  ON (B)(6) 2019, AN 18MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. WHILE DEPLOYING THE DEVICE, THE RIGHT DISC REMAINED CONVEX. THE DEVICE WAS RECAPTURED AND DEPLOYED BUT THE ISSUE PERSISTED. THE DEVICE WAS EXCHANGED FOR A 25MM PFO AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9484402 ↗