CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08022057012913), received between Sep 28, 2016 and Mar 4, 2026 — classified as 6 deaths, 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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.

• InjuryMar 4, 2026Insufficient Device Problem Information

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2025, A CARBOMEDICS TOP HAT AORTIC VALVE, S5-023, WAS IMPLANTED/EXPLANTED INTRA-OPERATIVELY DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24504218 ↗
• InjuryMar 5, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE S5-023 WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. PRE-PROCEDURE ECHO IMAGING MEASURED AORTA AT APPROXIMATELY 20MM WITH A MEAN PG OF 30. AFTER INITIALLY USING SIZERS AND RULING OUT SIZE 19 AND 21MM, SIZE 23MM TOP HAT WAS SELECTED BASED ON SIZING CRITERIA. DEVICE WAS IMPLANTED UTILIZING 12 STAY SUTURES AND COR KNOT SYSTEM. DUE TO PATIENT'S SMALL ANATOMY, THE SURGEON COMMENTED THAT THERE WAS LITTLE ROOM TO WORK AROUND THE VALVE DURING THE IMPLANTATION AND THE COR KNOT DEVICE WAS PRESENTING SOME CHALLENGES. AFTER DEVICE WAS IMPLANTED, AORTA WAS CLOSED, AND PATIENT WAS GRADUALLY BROUGHT OFF BYPASS AND CROSS CLAMP WAS REMOVED. TEE IMAGING AT THIS TIME REVEALED A PVL AT AN AREA ADJACENT TO THE LEFT CORONARY, THE AREA THE SURGEON WAS STATING THAT HAD LITTLE ROOM WHEN SUTURING. IT WAS ALSO DETERMINED THAT THE COR KNOT PROBABLY PERFORATED THE AORTIC WALL AT THAT TIME CONTRIBUTING TO THE PVL. OPTIONS WERE DISCUSSED AND IT WAS DECIDED TO REMOVE TOP HAT AND IMPLANT EITHER A BIOPROSTHETIC AORTIC VALVE OR ANOTHER MECHANICAL VALVE DEPENDING ON THE CONDITION OF THE AORTA POST EXPLANT. REMOVING THE TOP HAT WAS CHALLENGING DUE TO THE SNUG FIT. REPORTEDLY,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21522066 ↗
• InjuryMar 5, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE S5-023 WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. PRE-PROCEDURE ECHO IMAGING MEASURED AORTA AT APPROXIMATELY 20MM WITH A MEAN PG OF 30. AFTER INITIALLY USING SIZERS AND RULING OUT SIZE 19 AND 21MM, SIZE 23MM TOP HAT WAS SELECTED BASED ON SIZING CRITERIA. DEVICE WAS IMPLANTED UTILIZING 12 STAY SUTURES AND COR KNOT SYSTEM. DUE TO PATIENT'S SMALL ANATOMY, THE SURGEON COMMENTED THAT THERE WAS LITTLE ROOM TO WORK AROUND THE VALVE DURING THE IMPLANTATION AND THE COR KNOT DEVICE WAS PRESENTING SOME CHALLENGES. AFTER DEVICE WAS IMPLANTED, AORTA WAS CLOSED, AND PATIENT WAS GRADUALLY BROUGHT OFF BYPASS AND CROSS CLAMP WAS REMOVED. TEE IMAGING AT THIS TIME REVEALED A PVL AT AN AREA ADJACENT TO THE LEFT CORONARY, THE AREA THE SURGEON WAS STATING THAT HAD LITTLE ROOM WHEN SUTURING. IT WAS ALSO DETERMINED THAT THE COR KNOT PROBABLY PERFORATED THE AORTIC WALL AT THAT TIME CONTRIBUTING TO THE PVL. OPTIONS WERE DISCUSSED AND IT WAS DECIDED TO REMOVE TOP HAT AND IMPLANT EITHER A BIOPROSTHETIC AORTIC VALVE OR ANOTHER MECHANICAL VALVE DEPENDING ON THE CONDITION OF THE AORTA POST EXPLANT. REMOVING THE TOP HAT WAS CHALLENGING DUE TO THE SNUG FIT. REPORTEDLY,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21522011 ↗
• InjuryJul 19, 2024Leak/Splash; Leak/Splash

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT S5-023 THAT WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED DUE TO LEAKAGE/REGURGITATION AND WAS REPLACED WITH A MEDTRONIC AVALUS BIOPROSTHETIC VALVE. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19784715 ↗
• InjuryJul 19, 2024Leak/Splash; Leak/Splash

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT S5-023 THAT WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED DUE TO LEAKAGE/REGURGITATION AND WAS REPLACED WITH A MEDTRONIC AVALUS BIOPROSTHETIC VALVE. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19784708 ↗
• DeathDec 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION THROUGH THE PATIENT TRACKING DEPARTMENT. ON (B)(6)2022, A PATIENT RECEIVED A CARBOMEDICS TOP HAT VALVE S5-023. AS REPORTED, THE PATIENT PASSED AWAY AT A LATER DATE (EXACT DATE AND CAUSE UNKNOWN). NO OTHER DETAILS ABOUT THE PATIENT, EVENT OR ALLEGATION OF ANY DEVICE DYSFUNCTION HAVE YET BEEN RECEIVED FROM THE SITE. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION CAN BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18422353 ↗
• DeathDec 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION THROUGH THE PATIENT TRACKING DEPARTMENT. ON (B)(6)2022, A PATIENT RECEIVED A CARBOMEDICS TOP HAT VALVE S5-023. AS REPORTED, THE PATIENT PASSED AWAY AT A LATER DATE (EXACT DATE AND CAUSE UNKNOWN). NO OTHER DETAILS ABOUT THE PATIENT, EVENT OR ALLEGATION OF ANY DEVICE DYSFUNCTION HAVE YET BEEN RECEIVED FROM THE SITE. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION CAN BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18422352 ↗
• InjuryMay 11, 2022Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED ON THE PATIENT'S IMPLANT FORMS, A CARBOMEDICS TOP HAT VALVE (S5-023) WAS IMPLANTED ON (B)(6) 2022. THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND REPLACED WITH ANOTHER TOP HAT S5-023. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT. PER THE OPERATIONAL REPORT PROVIDED, THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS. THE PATIENT HAD POSITIVE BLOOD CULTURES WITH COAG-NEGATIVE STAPHYLOCOCCUS. PATIENT WAS PREVIOUSLY NOTED WITH AN ECHODENSITY ON THE ATRIAL SEPTUM. RECENT TRANSTHORACIC ECHOCARDIOGRAM SHOWED THE GRADIENT INCREASE ACROSS BOTH MITRAL AND AORTIC VALVES. AORTIC INSUFFICIENCY WAS ALSO NOTED. SINCE THE PATIENT HAD A RECENT SEVERE DETERIORATION OF RESPIRATORY FUNCTION, IT WAS DECIDED TO TO ATTEMPT THE SURGERY TO RECOGNIZE IF THE PATIENT'S SEPSIS CAN BE BETTER CONTROLLED AND TO RULE OUT VALVULAR DYSFUNCTION DUE TO INFECTION. DURING THE TEE PERFORMED IN OR, BOTH MITRAL AND AORTIC VALVES SEEMED TO BE OPENING AND CLOSING NORMALLY. WHILE THERE WAS INCREASED GRADIENT ACROSS THE VALVE, NO SEVERE DYSFUNCTION WAS NO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis; Hypoxia

  MAUDE report 14366634 ↗
• InjuryMay 11, 2022Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION RECEIVED ON THE PATIENT'S IMPLANT FORMS, A CARBOMEDICS TOP HAT VALVE (S5-023) WAS IMPLANTED ON (B)(6) 2022. THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND REPLACED WITH ANOTHER TOP HAT S5-023. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT. PER THE OPERATIONAL REPORT PROVIDED, THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS. THE PATIENT HAD POSITIVE BLOOD CULTURES WITH COAG-NEGATIVE STAPHYLOCOCCUS. PATIENT WAS PREVIOUSLY NOTED WITH AN ECHODENSITY ON THE ATRIAL SEPTUM. RECENT TRANSTHORACIC ECHOCARDIOGRAM SHOWED THE GRADIENT INCREASE ACROSS BOTH MITRAL AND AORTIC VALVES. AORTIC INSUFFICIENCY WAS ALSO NOTED. SINCE THE PATIENT HAD A RECENT SEVERE DETERIORATION OF RESPIRATORY FUNCTION, IT WAS DECIDED TO TO ATTEMPT THE SURGERY TO RECOGNIZE IF THE PATIENT'S SEPSIS CAN BE BETTER CONTROLLED AND TO RULE OUT VALVULAR DYSFUNCTION DUE TO INFECTION. DURING THE TEE PERFORMED IN OR, BOTH MITRAL AND AORTIC VALVES SEEMED TO BE OPENING AND CLOSING NORMALLY. WHILE THERE WAS INCREASED GRADIENT ACROSS THE VALVE, NO SEVERE DYSFUNCTION WAS NOT

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis; Hypoxia

  MAUDE report 14366540 ↗
• InjuryApr 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, THE TOP HAT VALVE SIZE 23 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14193894 ↗
• InjuryApr 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, THE TOP HAT VALVE SIZE 23 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14193881 ↗
• MalfunctionMar 17, 2022Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023 WAS IMPLANTED. ON (B)(6) 2022, THE FLUOROSCOPY WAS PERFORMED DUE TO THE VALVE THROMBUS. A SLIGHT VALVE INSUFFICIENCY WAS OBSERVED IN ONE OF LEAFLETS, BUT THE PATIENT'S SYMPTOMS WERE MILD AND TREATED WITH ANTICOAGULANT THERAPY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 13793676 ↗
• DeathApr 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A S5-023 VALVE WAS IMPLANTED ON (B)(6) 2020 AND THE PATIENT PASSED AWAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11605743 ↗
• DeathApr 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A S5-023 VALVE WAS IMPLANTED ON (B)(6) 2020 AND THE PATIENT PASSED AWAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11605704 ↗
• DeathApr 4, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS TOP HAT S5-023 AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A SECOND CARBOMEDICS S5-023. NO FURTHER INFORMATION WAS RECEIVED. THE MANUFACTURER RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE. THE REASON FOR THE EXPLANT WAS THROMBOSIS SECONDARY DUE TO PATIENT STOPPING COUMADIN. NO DEVICE MALFUNCTION OCCURRED AND THE EXPLANTED DEVICE WAS DISCARDED AFTER THE PROCEDURE. PATIENT OUTCOME WAS DEATH.

  Patient problems: Death; No Information; Thrombosis

  MAUDE report 9926212 ↗
• DeathApr 4, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS TOP HAT S5-023 AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A SECOND CARBOMEDICS S5-023. NO FURTHER INFORMATION WAS RECEIVED. THE MANUFACTURER RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE. THE REASON FOR THE EXPLANT WAS THROMBOSIS SECONDARY DUE TO PATIENT STOPPING COUMADIN. NO DEVICE MALFUNCTION OCCURRED AND THE EXPLANTED DEVICE WAS DISCARDED AFTER THE PROCEDURE. PATIENT OUTCOME WAS DEATH.

  Patient problems: Death; No Information; Thrombosis

  MAUDE report 9926211 ↗
• InjuryMar 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2011 A PATIENT RECEIVED A CARBOMEDICS TOP HAT S5-023 MECHANICAL HEART VALVE AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MITRAL VALVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9896225 ↗
• InjuryMar 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2011 A PATIENT RECEIVED A CARBOMEDICS TOP HAT S5-023 MECHANICAL HEART VALVE. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER VALVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9896223 ↗
• InjuryMar 11, 2020Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE STUDY PUBLICATION 'SUMMARY REPORT OF CLINICAL FOLLOW-UP AND STATISTICAL ANALYSIS OF CPHV-S5 PROSTHETIC HEART VALVE'. THIS STUDY AIMS TO EVALUATE THE MID- AND LONG-TERM SAFETY OF PROSTHETIC HEART VALVE AFTER IMPLANTATION THROUGH A RETROSPECTIVE FOLLOW-UP ANALYSIS. A TOTAL OF 300 PATIENTS WERE FOLLOWED-UP IN THIS STUDY. THE RESULTS OF THIS RETROSPECTIVE FOLLOW-UP STUDY SHOWED THAT THE CPHV-S5 (CARBOMEDICS TOP HAT) PROSTHETIC HEART VALVE HAS LOW INCIDENCES OF RELATED CLINICAL EVENTS AFTER IMPLANTATION, WITH NO OCCURRENCE OF UNEXPECTED ADVERSE EVENTS, THUS HAS GOOD MID- AND LONG-TERM SAFETY. AMONG THE RESULTS PRESENTED IN THIS STUDY, ONE PATIENT EXPERIENCED A DEVICE DYSFUNCTION (PERIMITRAL LEAK, SPECIFIED AS PERIVALVULAR LEAK, NHYA CLASS II) LEADING TO A REINTERVENTION. THE TOP HAT VALVE WAS IMPLANTED ON (B)(6) 2013 AND A RE-OPERATION (PERIMITRAL LEAK CLOSURE) WAS PERFORMED ON (B)(6) 2014. THE PATIENT WAS REPORTEDLY WELL AFTER THE PROCEDURE. FROM THE STUDY, IT IS NOT CONFIRMED IF THE TOP HAT VALVE WAS EXPLANTED AS A RESULT OF THE PERIVALVULAR REGURGITATION. HOWEVER, PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE TO

  Patient problems: Aortic Insufficiency; Mitral Regurgitation

  MAUDE report 9821972 ↗
• InjuryMar 11, 2020Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE STUDY PUBLICATION 'SUMMARY REPORT OF CLINICAL FOLLOW-UP AND STATISTICAL ANALYSIS OF CPHV-S5 PROSTHETIC HEART VALVE'. THIS STUDY AIMS TO EVALUATE THE MID- AND LONG-TERM SAFETY OF PROSTHETIC HEART VALVE AFTER IMPLANTATION THROUGH A RETROSPECTIVE FOLLOW-UP ANALYSIS. A TOTAL OF 300 PATIENTS WERE FOLLOWED-UP IN THIS STUDY. THE RESULTS OF THIS RETROSPECTIVE FOLLOW-UP STUDY SHOWED THAT THE CPHV-S5 (CARBOMEDICS TOP HAT) PROSTHETIC HEART VALVE HAS LOW INCIDENCES OF RELATED CLINICAL EVENTS AFTER IMPLANTATION, WITH NO OCCURRENCE OF UNEXPECTED ADVERSE EVENTS, THUS HAS GOOD MID- AND LONG-TERM SAFETY. AMONG THE RESULTS PRESENTED IN THIS STUDY, ONE PATIENT EXPERIENCED A DEVICE DYSFUNCTION (PERIMITRAL LEAK, SPECIFIED AS PERIVALVULAR LEAK, NHYA CLASS II) LEADING TO A REINTERVENTION. THE TOP HAT VALVE WAS IMPLANTED ON (B)(6)2013 AND A RE-OPERATION (PERIMITRAL LEAK CLOSURE) WAS PERFORMED ON (B)(6)2014 . THE PATIENT WAS REPORTEDLY WELL AFTER THE PROCEDURE. FROM THE STUDY, IT IS NOT CONFIRMED IF THE TOP HAT VALVE WAS EXPLANTED AS A RESULT OF THE PERIVALVULAR REGURGITATION. HOWEVER, PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE TOP

  Patient problems: Aortic Insufficiency; Mitral Regurgitation

  MAUDE report 9821956 ↗
• InjuryDec 6, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED BY THE DEVICE TRACKING DEPARTMENT THAT A TOP HAT S5-023 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2019. THE PATIENT ULTIMATELY RECEIVED A TOP HAT S5-021. ADDITIONAL INFORMATION RECEIVED FROM THE SITE CONFIRMED THAT THE PATIENT HAD A BICUSPID AORTIC VALVE, ASCENDING AORTIC ANEURYSM AND SYMPTOMATIC CALCIFIC AORTIC STENOSIS. NO INFORMATION ON THE REASON FOR THE INTRAOPERATIVE EXPLANT WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9434574 ↗
• InjuryDec 6, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED BY THE DEVICE TRACKING DEPARTMENT THAT A TOP HAT S5-023 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2019. THE PATIENT ULTIMATELY RECEIVED A TOP HAT S5-021. ADDITIONAL INFORMATION RECEIVED FROM THE SITE CONFIRMED THAT THE PATIENT HAD A BICUSPID AORTIC VALVE, ASCENDING AORTIC ANEURYSM AND SYMPTOMATIC CALCIFIC AORTIC STENOSIS. NO INFORMATION ON THE REASON FOR THE INTRAOPERATIVE EXPLANT WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9434566 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON (B)(4) INVESTIGATION: THIS EVENT REFERS TO CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-023 IMPLANTED ON (B)(6) 2014 IN AORTIC POSITION. IT WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE, SAME SIZE S5-023 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8333687 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2010 A CARBOMEDICS TOP HAT S5-023 MECHANICAL AORTIC HEART VALVE WAS IMPLANTED. ON (B)(6) 2018 THE VALVE WAS EXPLANTED DUE TO SEVERE AORTIC STENOSIS AND REPLACED WITH A CARBOMEDICS S5-021 MECHANICAL AORTIC HEART VALVE. PATIENT CONDITION IS REPORTED AS DOING WELL.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 7401468 ↗
• InjurySep 28, 2016Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  RECEIVED E-MAIL DATED 31 AUG 2016 FROM A PATIENT: HELLO, MY NAME IS (B)(6) AND I HAD AN AORTIC HEART VALVE REPLACED WITH ONE OF YOURS ON (B)(6) 2011 AT (B)(6). IT ONLY LASTED 4 YEARS, I WAS IN TERRIBLE SHAPE LAST YEAR. YOU SEE MY DOCTOR USED ON THAT WAS UNDER SIZED, MY BSA IS 2.2 AND HE USED A SIZE 23. IT LEAKED FROM THE VERY FIRST DAY, BUT THEY MISLEAD AND ASSURED ME THAT IT WAS FINE. SO LIKE I SAID LAST YEAR THE PRESSURE GOT TO IT AND I DAMN NEAR DIED. THEY WERE HACKS AND TRIED TO PLUG IT COVER UP THEIR MISTAKE. THOSE BLEW OUT TOO. AND I OPTED TO GO TO (B)(6), THEY TOO NOTED THE VALVE SIZE WAS TOO SMALL. THEY USED AN ON-X 27-29, 4-6 SIZES BIGGER I BELIEVE THAN YOURS. I HOPE IT WAS NOT YOUR CHART THAT CONFUSED THEM, I AM VERY UNHAPPY WITH WHAT HAPPENED. AND PAYING FOR 3 SURGERIES WHEN 1 SHOULD HAVE BEEN ALL I NEEDED. INFO FROM PATIENT TRACKING AS OF 07 SEP 2016: OUR RECORD SHOWS THAT THE PATIENT HAS A S5-023 SN # (B)(4) IMPLANTED ON (B)(6) 2011 AT (B)(6). PATIENT MALE DOB (B)(6).

  Patient problems: Aortic Insufficiency; No Code Available

  MAUDE report 5984124 ↗