CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08022057012906), received between Feb 5, 2016 and Aug 20, 2025 — classified as 7 deaths, 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (25 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Break; Break

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE, S5-021 WAS SUCCESSFULLY IMPLANTED. ONCE ALL SUTURES WERE IN PLACE, THEY STARTED ROTATING THE LEAFLETS WITH A RUBBER SHODDED HEMOSTAT AND A DEBAKEY. IT WAS AT THIS TIME THAT THE LEAFLET BROKE. THEY HAD TO REMOVE THE PIECES, FLUSH AND SUCTION THE AREA AS WELL AS REMOVE THE TOP HAT VALVE AND PLACE A SECOND ONE. THIS ADDED AT LEAST AN HOUR TO THE CASE. THE SECOND TOP HAT WAS PLACED SUCCESSFULLY. AS REPORTED PATIENT IS DOING WELL AND WAS COMING OUT OF THE ICU AND TO THE FLOOR WITH STABLE HEMODYNAMIC AND EXTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 22847320 ↗
• InjuryAug 20, 2025Break; Break

  ON (B)(6) 2025, A CARBOMEDICS TOP HAT VALVE, S5-021 WAS SUCCESSFULLY IMPLANTED. ONCE ALL SUTURES WERE IN PLACE, THEY STARTED ROTATING THE LEAFLETS WITH A RUBBER SHODDED HEMOSTAT AND A DEBAKEY. IT WAS AT THIS TIME THAT THE LEAFLET BROKE. THEY HAD TO REMOVE THE PIECES, FLUSH AND SUCTION THE AREA AS WELL AS REMOVE THE TOP HAT VALVE AND PLACE A SECOND ONE. THIS ADDED AT LEAST AN HOUR TO THE CASE. THE SECOND TOP HAT WAS PLACED SUCCESSFULLY. AS REPORTED PATIENT IS DOING WELL AND WAS COMING OUT OF THE ICU AND TO THE FLOOR WITH STABLE HEMODYNAMIC AND EXTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 22847310 ↗
• DeathMar 27, 2024Inadequacy 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 THAT A PATIENT WHO UNDERWENT A REOPERATION WITH A TOP HAT SIZE 21 AORTIC MECHANICAL VALVE PASSED AWAY. THE TOP HAT VALVE HAD BEEN IMPLANTED TO REPLACE A SUTURELESS AORTIC BIOPROSTHESIS (PERCEVAL PLUS SIZE L, SN (B)(6)) WHICH HAD SHOWN A LEAFLET NOT COAPTING COMPLETELY LEADING TO CENTRAL LEAK. AS PER INFORMATION RECEIVED, THE REOPERATION WAS CARRIED OUT IN THE EVENING OF THE SAME DAY OF PERCEVAL VALVE IMPLANT. APPROXIMATELY 8 HOURS LATER. REPORTEDLY, THE PATIENT WAS ALREADY VERY COMPLICATED. THE PREOPERATIVE ECHOCARDIOGRAPHY WAS SHOWING THE FOLLOWING VALUES: AORTIC VALVE AREA (AVA) 1 SQUARE CENTIMETER WITH A MEAN GRADIENT OF 46/25 MMHG, SEVERE MITRAL REGURGITATION (MR) FOR 2-3 MONTHS, GRADE 2 TRICUSPID REGURGITATION (TR), PULMONARY ARTERY PRESSURE (PAP) OF 45 MMHG, EF %45. THE PATIENT HAD UNDERGONE STENTING OF THE RCA AND CX ARTERIES ONE YEAR BEFORE; THE STENTS WERE FOUND PATENT IN THE PREOPERATIVE CORONARY ANGIOGRAPHY. ACCORDING TO FURTHER INFORMATION RECEIVED, THE PATIENT ANNULUS SIZE WAS 27 MM AND IT WAS CONFIRMED THAT THE TOP HAT MECHANICAL VALVE WAS POSITIONED SUPRA-ANNULARLY.

  Patient problems: Insufficient Information

  MAUDE report 18986344 ↗
• InjuryOct 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT AORTIC HEART VALVE SIZE 21 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2023. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17931864 ↗
• InjuryOct 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A CARBOMEDICS TOP HAT AORTIC HEART VALVE SIZE 21 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2023. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17931855 ↗
• DeathMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A 51 YEAR OLD PATIENT UNDERWENT AVR WITH CARBOMEDICS TOP HAT SUPRA-ANNULAR AORTIC PROSTHESIS SIZE 21. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON FIRST POST-OPERATIVE DAY, THE PATIENT EXPERIENCED A SUDDEN DECREASE IN BLOOD PRESSURE AND HEART RATE COULDN'T BE MEASURED. ULTIMATELY, THE PATIENT PASSED AWAY. NO INFORMATION IS AVAILABLE TO THE MANUFACTURER REGARDING PATIENT CLINICAL HISTORY AND RISK FACTORS, DETAILS ON SURGICAL PROCEDURE (E.G. IF CONCOMITANT PROCEDURES WERE PERFORMED). NO DATA ARE AVAILABLE TO THE MANUFACTURER REGARDING DEVICE FUNCTIONALITY POST-OP. IT WAS REPORTED THAT THE SURGEON SUSPECTED THAT PATIENT DEATH WAS CAUSED BY LEAFLET BLOCKAGE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16946724 ↗
• MalfunctionMar 14, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2022, AFTER IMPLANTING AND SUTURING THE TOP HAT VALVE SIZE 21, IT WAS REALIZED THAT ONE OF THE LEAFLETS WAS NOT MOVING SMOOTHLY AND WAS SUSPECTED TO BE STUCK. THUS, THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER VALVE BUT THE SAME MODEL. AS REPORTED, THERE WAS NO IMPACT FOR THE PATIENT. PATIENT HAD A GOOD OUTCOME AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759906 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT AORTIC HEART VALVE S5-021 WAS IMPLANTED ON (B)(6) 2010 AND EXPLANTED ON (B)(6) 2022. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 13592505 ↗
• InjuryFeb 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT AORTIC HEART VALVE S5-021 WAS IMPLANTED ON (B)(6) 2010 AND EXPLANTED ON (B)(6) 2022. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13592479 ↗
• DeathOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT WITH CORCYM DEVICES DUE TO LESIONS ON BOTH VALVES. THE PATIENT RECEIVED AN OPTIFORM SIZE 27 IN MITRAL POSITION (REF (B)(4)) AND A TOP HAT SIZE 21 IN AORTIC POSITION. THE DEVICES WERE SAFELY IMPLANTED DURING THE SURGERY AND PATIENT DID WELL DURING SURGERY. THERE WAS NO ABNORMALITY OR MALFUNCTION NOTED ON THE VALVE DURING SURGERY. THE VALVES WERE TESTED AFTER IMPLANTATION AND CONFIRMED THE POSITION AND OPENING AND CLOSING FUNCTION WAS GOOD. AFTER THE OPERATION, THE HEART RATE AND BLOOD PRESSURE WERE STABLE, SO THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION. TWO HOURS POST-OPERATION, THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE (BLOOD PRESSURE 0), BUT THE HEARTBEAT REMAINED. THEN, THE PATIENT DIED. THE EMERGENCY ULTRASOUND SHOWED INADEQUATE OPENING AND CLOSING MOTION FOR S5 VALVE. SINCE NO FURTHER INVESTIGATION ON THE PATIENT WAS POSSIBLE, THE SITE COULD NOT ASSESS THE RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT, NOR IF THE DEVICES MALFUNCTIONED OR NOT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12598308 ↗
• DeathOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT WITH CORCYM DEVICES DUE TO LESIONS ON BOTH VALVES. THE PATIENT RECEIVED AN OPTIFORM SIZE 27 IN MITRAL POSITION (REF (B)(4)) AND A TOP HAT SIZE 21 IN AORTIC POSITION. THE DEVICES WERE SAFELY IMPLANTED DURING THE SURGERY AND PATIENT DID WELL DURING SURGERY. THERE WAS NO ABNORMALITY OR MALFUNCTION NOTED ON THE VALVE DURING SURGERY. THE VALVES WERE TESTED AFTER IMPLANTATION AND CONFIRMED THE POSITION AND OPENING AND CLOSING FUNCTION WAS GOOD. AFTER THE OPERATION, THE HEART RATE AND BLOOD PRESSURE WERE STABLE, SO THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION. TWO HOURS POST-OPERATION, THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE (BLOOD PRESSURE 0), BUT THE HEARTBEAT REMAINED. THEN, THE PATIENT DIED. THE EMERGENCY ULTRASOUND SHOWED INADEQUATE OPENING AND CLOSING MOTION FOR S5 VALVE. SINCE NO FURTHER INVESTIGATION ON THE PATIENT WAS POSSIBLE, THE SITE COULD NOT ASSESS THE RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT, NOR IF THE DEVICES MALFUNCTIONED OR NOT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12598300 ↗
• InjuryApr 8, 2021Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER RECEIVED INFORMATION ON A TOP HAT S5-021 EXPLANT THAT OCCURRED ON (B)(6) 2016. THE DEVICE WAS IMPLANTED ON (B)(6) 2016 AS PART OF A RE-DO AORTIC VALVE REPLACEMENT (AVR). DURING THE PROCEDURE, SURGICAL TREATMENT OF WOUND INFECTION WAS ALSO PERFORMED. AFTER IMPLANT, THE TOP HAT LEAFLETS APPEARED WELL OPENED AND CLOSED WITHOUT PERIVALVULAR LEAKAGE. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS RETURNED TO THE ICU. THE PATIENT WAS POSTOPERATIVELY GIVEN ANTI-INFECTION, CARDIOTONIC, DIURETIC, POTASSIUM SUPPLEMENT AND OTHER SYMPTOMATIC AND SUPPORTIVE TREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 WITH IMPROVED CONDITION. THE ECHO PERFORMED ON (B)(6) 2016 AND (B)(6) 2016 SHOWED THAT THE VALVE LEAFLETS WERE OPENED AND CLOSED WELL, THE PRESSURE GRADIENT WAS 28MMHG AND 25MMHG, RESPECTIVELY, AND NO PERIVALVULAR LEAKAGE WAS OBSERVED IN EITHER ECHO EXAM. THE ECHO PERFORMED ON (B)(6) 2016 SHOWED GOOD OPENING AND CLOSING OF VALVE LEAFLET, PRESSURE GRADIENT OF 25MMHG, AND A VISIBLE PERIVALVULAR LEAKAGE. THE DIAGNOSIS ON DISCHARGE WAS OF PERIVALVULAR LEAKAGE AFTER AVR FOR INFECTIVE ENDOCARDITIS; RE-AVR FOR PERIVALVULAR LEAKAGE; BEHCET'S DISEASE; LATENT TUBERCULOSIS. THE PA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 11635036 ↗
• InjuryApr 8, 2021Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER RECEIVED INFORMATION ON A TOP HAT S5-021 EXPLANT THAT OCCURRED ON (B)(6) 2016. THE DEVICE WAS IMPLANTED ON (B)(6) 2016 AS PART OF A RE-DO AORTIC VALVE REPLACEMENT (AVR). DURING THE PROCEDURE, SURGICAL TREATMENT OF WOUND INFECTION WAS ALSO PERFORMED. AFTER IMPLANT, THE TOP HAT LEAFLETS APPEARED WELL OPENED AND CLOSED WITHOUT PERIVALVULAR LEAKAGE. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS RETURNED TO THE ICU. THE PATIENT WAS POSTOPERATIVELY GIVEN ANTI-INFECTION, CARDIOTONIC, DIURETIC, POTASSIUM SUPPLEMENT AND OTHER SYMPTOMATIC AND SUPPORTIVE TREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 WITH IMPROVED CONDITION. THE ECHO PERFORMED ON (B)(6) 2016 SHOWED THAT THE VALVE LEAFLETS WERE OPENED AND CLOSED WELL, THE PRESSURE GRADIENT WAS 28 MMHG AND 25 MMHG, RESPECTIVELY, AND NO PERIVALVULAR LEAKAGE WAS OBSERVED IN EITHER ECHO EXAM. THE ECHO PERFORMED ON (B)(6) 2016 SHOWED GOOD OPENING AND CLOSING OF VALVE LEAFLET, PRESSURE GRADIENT OF 25 MMHG, AND A VISIBLE PERIVALVULAR LEAKAGE. THE DIAGNOSIS ON DISCHARGE WAS OF PERIVALVULAR LEAKAGE AFTER AVR FOR INFECTIVE ENDOCARDITIS; RE-AVR FOR PERIVALVULAR LEAKAGE; BEHCET'S DISEASE; LATENT TUBERCULOSIS. THE PATIENT WAS RE-

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 11635027 ↗
• InjuryOct 23, 2020Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING DEPARTMENT INDICATING THE FOLLOWING IN THE PATIENT REGISTRATION FORM: A CARBOMEDICS TOP HAT VALVE S5-021 WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2020. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THIS WAS A YOUNG PATIENT WHO RECEIVED AN AVR AND MVR FOR RHEUMATIC HEART DISEASE. THE PATIENT WAS LIVING OVERSEAS AND THERE WAS AN UNKNOWN HISTORY OF INR MANAGEMENT, THERE WAS A PROGRESSIVE INCREASE IN THE AORTIC VALVE GRADIENT HOWEVER ON ECHO THE LEAFLETS APPEARED TO BE MOBILE. THE 21MM VALVE WAS EXPLANTED HAVING BEEN SEEN TO BE FUNCTIONAL WITH A CONCERN THAT THE MITRAL VALVE MAY HAVE BEEN IMPINGING UPON THE AORTIC VALVE. IT WAS POSSIBLE TO UP SIZE TO A 23MM VALVE WITH THE POSITION OF THE NEW IMPLANT ROTATED TO AVOID ANY FURTHER POTENTIAL MITRAL VALVE IMPACT. IT WAS CONFIRMED THAT NO DEVICE MALFUNCTIONS WERE IDENTIFIED AND THAT THE PATIENT HAS DONE WELL AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10731465 ↗
• InjuryOct 23, 2020Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Gradient Increase; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING DEPARTMENT INDICATING THE FOLLOWING IN THE PATIENT REGISTRATION FORM: A CARBOMEDICS TOP HAT VALVE S5-021 WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2020. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THIS WAS A YOUNG PATIENT WHO RECEIVED AN AVR AND MVR FOR RHEUMATIC HEART DISEASE. THE PATIENT WAS LIVING OVERSEAS AND THERE WAS AN UNKNOWN HISTORY OF INR MANAGEMENT, THERE WAS A PROGRESSIVE INCREASE IN THE AORTIC VALVE GRADIENT HOWEVER ON ECHO THE LEAFLETS APPEARED TO BE MOBILE. THE 21MM VALVE WAS EXPLANTED HAVING BEEN SEEN TO BE FUNCTIONAL WITH A CONCERN THAT THE MITRAL VALVE MAY HAVE BEEN IMPINGING UPON THE AORTIC VALVE. IT WAS POSSIBLE TO UP SIZE TO A 23MM VALVE WITH THE POSITION OF THE NEW IMPLANT ROTATED TO AVOID ANY FURTHER POTENTIAL MITRAL VALVE IMPACT. IT WAS CONFIRMED THAT NO DEVICE MALFUNCTIONS WERE IDENTIFIED AND THAT THE PATIENT HAS DONE WELL AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10731069 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020, A CARBOMEDICS TOP HAT AORTIC VALVE S5-021 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. A SIMILAR VALVE BUT DIFFERENT SIZE S5-019 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10435167 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020, A CARBOMEDICS TOP HAT AORTIC VALVE S5-021 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. A SIMILAR VALVE BUT DIFFERENT SIZE S5-019 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10435164 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DATABASE. BASED ON THE INFORMATION REPORTED ON THE PATIENT REGISTRATION FORM,ON (B)(6) 2010, A PATIENT RECEIVED A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-021. ON (B)(6) 2020, THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL SUTURELESS AORTIC VALVE PVS21. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10435114 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DATABASE. BASED ON THE INFORMATION REPORTED ON THE PATIENT REGISTRATION FORM, ON (B)(6) 2010, A PATIENT RECEIVED A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-021. ON (B)(6) 2020, THE DEVICE WAS EXPLANTED AND REPLACED WITH A PERCEVAL SUTURELESS AORTIC VALVE PVS21. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10435106 ↗
• InjuryMar 11, 2020Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT CONFIRMING THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2016. A SECOND REPORT HAS BEEN CREATED FOR THE EXPLANT OF THE SECOND VALVE IN (B)(6) 2016 (REF 3005687633-2021-00110) AS REPORTED, A 29 YEARS OLD PATIENT RECEIVED A CARBOMEDICS TOP HAT MODEL S5-021 ON (B)(6) 2016. THE PRE-OPERATIVE DIAGNOSIS WAS OF INFECTIVE ENDOCARDITIS, AORTIC VALVE VEGETATION, AORTIC REGURGITATION, MITRAL AND TRICUSPID VALVE ENLARGEMENT, CARDIOMEGALY, PULMONARY HYPERTENSION, CARDIAC FUNCTION GRADE III. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT + MITRAL VALVE EXPLORATION + MYOCARDIAL ABSCESS AND REMOVAL OF LEAFLET NEOPLASM + LEFT CORONARY SINUS ANEURYSM RUPTURED INTO THE ANEURYSM WALL RESECTION + REPAIR OF VENTRICULAR OUTLET. THE PATIENT RECEIVED TREATMENT AFTER THE SURGERY, AND WAS DISCHARGED IN GOOD CONDITIONS ON (B)(6) 2016. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2016. A SURGICAL INCISION ABOUT 20 CM IN LENGTH WAS OBSERVED IN THE MIDDLE OF THE STERNUM, A FISTULA ABOUT 5 CM IN LENGTH WAS OBSERVED IN THE UPPER THIRD, A LITTLE NECROTIC TISSUE AND EXUDATE WERE OBSERVED IN THE FISTULA, WITH SURROUNDING REDNESS AND SLIGHTLY HIG

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 9822018 ↗
• InjuryMar 11, 2020Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT CONFIRMING THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2016. A SECOND REPORT HAS BEEN CREATED FOR THE EXPLANT OF THE SECOND VALVE IN (B)(6) 2016 (REF 1718850-01050-2021). AS REPORTED, A 29 YEARS OLD PATIENT RECEIVED A CARBOMEDICS TOP HAT MODEL S5-021 ON (B)(6) 2016. THE PRE-OPERATIVE DIAGNOSIS WAS OF INFECTIVE ENDOCARDITIS, AORTIC VALVE VEGETATION, AORTIC REGURGITATION, MITRAL AND TRICUSPID VALVE ENLARGEMENT, CARDIOMEGALY, PULMONARY HYPERTENSION, CARDIAC FUNCTION GRADE III. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT + MITRAL VALVE EXPLORATION + MYOCARDIAL ABSCESS AND REMOVAL OF LEAFLET NEOPLASM + LEFT CORONARY SINUS ANEURYSM RUPTURED INTO THE ANEURYSM WALL RESECTION + REPAIR OF VENTRICULAR OUTLET. THE PATIENT RECEIVED TREATMENT AFTER THE SURGERY, AND WAS DISCHARGED IN GOOD CONDITIONS ON (B)(6) 2016. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2016. A SURGICAL INCISION ABOUT 20 CM IN LENGTH WAS OBSERVED IN THE MIDDLE OF THE STERNUM, A FISTULA ABOUT 5 CM IN LENGTH WAS OBSERVED IN THE UPPER THIRD, A LITTLE NECROTIC TISSUE AND EXUDATE WERE OBSERVED IN THE FISTULA, WITH SURROUNDING REDNESS AND SLIGHTLY HIGHE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 9822007 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  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 (0.33%, 0.07% PATIENT-YEAR) HAD TWO ADVERSE EVENTS INDICATED AS VALVE RELATED: 'CHEST PAIN, SUBACUTE INFECTIVE ENDOCARDITIS' ON (B)(6) 2016 AND THE PATIENT PASSED AWAY ON (B)(6) 2017. THE PATIENT RECEIVED THE CPHV-S5 ON (B)(6) 2016. IT WAS CONFIRMED THAT THE PATIENT'S ENDOCARDITIS WAS TREATED PHARMACOLOGICALLY. WITH ANTIBIOTIC TREATMENT, THE PATIENT HAD AN APPARENT IMPROVEMENT AND RECOVERED TO A GENERALLY ACCEPTABLE CONDITION. HOWEVER, THE PATIENT'S ENDOCARDITIS WAS REPORTEDLY NOT COMPLETE

  Patient problems: Chest Pain; Death; Endocarditis; Multiple Organ Dysfunction Syndrome

  MAUDE report 9821836 ↗
• DeathMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  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 (0.33%, 0.07% PATIENT-YEAR) HAD TWO ADVERSE EVENTS INDICATED AS VALVE RELATED: 'CHEST PAIN, SUBACUTE INFECTIVE ENDOCARDITIS' ON (B)(6) 2016 AND THE PATIENT PASSED AWAY ON (B)(6) 2017. THE PATIENT RECEIVED THE CPHV-S5 ON (B)(6) 2016. IT WAS CONFIRMED THAT THE PATIENT'S ENDOCARDITIS WAS TREATED PHARMACOLOGICALLY. WITH ANTIBIOTIC TREATMENT, THE PATIENT HAD AN APPARENT IMPROVEMENT AND RECOVERED TO A GENERALLY ACCEPTABLE CONDITION. HOWEVER, THE PATIENT'S ENDOCARDITIS WAS REPORTEDLY NOT COMPLETE

  Patient problems: Chest Pain; Death; Endocarditis; Multiple Organ Dysfunction Syndrome

  MAUDE report 9821828 ↗
• InjuryOct 10, 2019Adverse 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) 2018 A PATIENT RECEIVED A CARBOMEDICS TOPHAT S5-021 MECHANICAL HEART VALVE AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A S5-023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 IDENTIFIED THAT THE VALVE WAS EXPLANTED AS A RESULT OF ENDOCARDITIS. THERE WERE NO DEVICE MALFUNCTIONS IDENTIFIED AND THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. BASED ON THIS ASSESSMENT THERE IS NO REASONABLE INFORMATION SUGGESTING A RELATIONSHIP BETWEEN THE DEVICE AND THE ENDOCARDITIS.

  Patient problems: Endocarditis; No Information

  MAUDE report 9177358 ↗
• InjuryOct 10, 2019Adverse 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) 2018 A PATIENT RECEIVED A CARBOMEDICS TOPHAT S5-021 MECHANICAL HEART VALVE AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A S5-023. ADDITIONAL INFORMATION RECEIVED ON NOV. 22, 2019 IDENTIFIED THAT THE VALVE WAS EXPLANTED AS A RESULT OF ENDOCARDITIS. THERE WERE NO DEVICE MALFUNCTIONS IDENTIFIED AND THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. BASED ON THIS ASSESSMENT THERE IS NO REASONABLE INFORMATION SUGGESTING A RELATIONSHIP BETWEEN THE DEVICE AND THE ENDOCARDITIS.

  Patient problems: Endocarditis; No Information

  MAUDE report 9177340 ↗