SJM™ Masters Series 27MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05414734006460), received between Jan 8, 2019 and Apr 26, 2024 — classified as 1 death, 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM MASTERS MITRAL MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANTATION. PATIENT WAS ON WARFARIN. INTERNATIONAL NORMALIZED RATIO WAS 1.8. DURING PREPARATION, THE LEAFLETS FUNCTIONED NORMALLY. FLAP HOLDER WAS USED TO TEST LEAFLET FUNCTION. ONCE IMPLANTED, THE VALVE LEAFLETS BECAME STUCK AND MOVEMENT WAS RESTRICTED. THE VALVE WAS EXPLANTED AND A REPLACEMENT 27MM MASTERS MITRAL MECHANICAL HEART VALVE WAS IMPLANTED SUCCESSFULLY. ONCE THE VALVE WAS EXPLANTED, THE LEAFLETS FUNCTIONED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194323 ↗
• InjuryDec 19, 2023Perivalvular Leak; Perivalvular Leak

  THE ARTICLE, "3D PRINTING FROM TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR PLANNING MITRAL PARAVALVULAR LEAK CLOSURE ¿ FEASIBILITY STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A PATIENT THE UNDERWENT MITRAL VALVE REPLACEMENT SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PARAVALVULAR LEAK OF THE MITRAL PROSTHESIS VALVE. A DECISION WAS MADE TO IMPLANT A 12-5MM OCCLUTECH PARAVALVULAR LEAK DEVICE. THE PATIENT STATUS WAS REPORTED STABLE AFTER ONE YEAR FOLLOW UP. THE ARTICLE CONCLUDED 3D-PRINTING FROM 3D-TEE IS TECHNICALLY FEASIBLE. BOTH SHAPE AND LOCATION OF PVLS ARE PRESERVED DURING MODEL PREPARATION AND PRINTING. IT REMAINS TO BE TESTED WHETHER 3D PRINTING WOULD IMPROVE OUTCOMES OF PERCUTANEOUS PVL CLOSURE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MAREK JEDRZEJEK, DEPARTMENT OF CARDIOLOGY AND STRUCTURAL HEART DISEASES, MEDICAL UNIVERSITY OF SILESIA, KATOWICE, POLAND, WITH CORRESPONDING E-MAIL: [email protected]].

  Patient problems: Insufficient Information

  MAUDE report 18356646 ↗
• InjuryAug 1, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON 11 JULY 2023, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLETS COULDN'T MOVE DURING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PHYSICIAN STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE USED A TESTER OF SILICON TO TEST THE LEAFLET FUNCTION AND FOUND THAT ONE LEAFLET COULDN'T MOVE NORMALLY. SO, THE PHYSICIAN HAD TO EXPLANT THE VALVE, AND REPLACED A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE. ONCE EXPLANTED, THE ORIGINAL VALVE LEAFLET WAS NOT MOVING NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 60 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS STABLE IN THE POST OPERATIVE RECOVERY PERIOD. THE PATIENT WAS TAKING WARFARIN, AND THE LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.0-2.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435937 ↗
• InjuryMay 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE MITRAL STANDARD CUFF WAS SELECTED FOR AN IMPLANT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WAS MOVING NORMALLY WHEN TESTED. DURING THE PROCEDURE, AFTER THE IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLET COULDN'T MOVE DURING THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HE STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE USED A TESTER OF SILICON TO TEST THE LEAFLET FUNCTION, FOUND THAT THE LEAFLETS COULD OPEN AND CLOSE NORMALLY. THE PHYSICIAN CLOSED THE INCISION OF HEART, BUT THAT LEAFLET COULDN'T MOVE AGAIN. DEVICE WAS EXPLANTED, AND REPLACED A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE MITRAL STANDARD CUFF THAT WAS IMPLANTED AND LEAFLETS MOVED NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 90 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT WAS GIVEN WARFARIN AND AND INR WAS 2.5. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034103 ↗
• InjuryMar 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT A LEAFLET OF THE VALVE FRACTURED AS ONE WHOLE PIECE WHEN ROTATING THE VALVE WITH THE VALVE ROTATOR AND HOLDER HANDLE. IT WAS NOTED THAT THERE A HAD BEEN A BIT OF RESISTANCE WHEN ROTATING THE 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE IN THE CLOSED POSITION. NO OTHER INSTRUMENTS CAME IN CONTACT WITH THE VALVE AT THE TIME OF THE LEAFLET FRACTURE. THE IMPLANTING PHYSICIAN DID NOT TRY TO REINSERT THE FRACTURED LEAFLET AND NOTHING OTHER THAN THE VALVE HOLDER HANDLE WAS USED TO ROTATE THE VALVE. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE DECISION WAS MADE TO REMOVE THE FRACTURED LEAFLET PIECE AND THE 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE AND REPLACED IT WITH A 27MM EPIC VALVE TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT TAKEN OFF BYPASS AND PUT BACK ON AND REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. HOWEVER, AT AN UNKNOWN POINT THE PATIENT SUFFERED A STROKE. THE PATIENT WAS STABLE AND RECOVERING AT THE TIME OF REPORT, WITH FULL RECOVERY OF NEUROLOGICAL FUNCTION.

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 16474813 ↗
• MalfunctionJan 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT THE LEAFLET COMPLETELY DETACHED FROM THE VALVE WHILE INSIDE THE PATIENT. THE LEAFLET REMAINED UNBROKEN AND IN ONE PIECE WHEN IT DETACHED FROM THE VALVE. THE VALVE AND DETACHED LEAFLET WERE BOTH REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092251 ↗
• InjuryNov 1, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM MITRAL MASTERS VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS IMPLANTED, BUT THEN THE SURGEON OBSERVED A LEAK AND THE VALVE WAS INTRAOPERATIVELY REPLACED WITH A NEW 27MM MITRAL MASTERS VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICAL SIGNIFICANT DELAY AS THE RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705657 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "DELAYED HEMOLYTIC TRANSFUSION REACTION AFTER MITRA! VALVE REPLACEMENT : REPORT OF A CASE", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF DELAYED HEMOLYTIC TRANSFUSION REACTION (DHTR) AFTER MITRAL VALVE REPLACEMENT (MVR). A (B)(6) WOMAN WITH A HISTORY OF BLOOD TRANSFUSION WAS ADMITTED FOR MVR. PREOPERATIVE LABORATORY TEST WERE NEGATIVE FOR IRREGULAR ANTIBODIES EXCEPT ANTI-DIA. SHE UNDERWENT MVR USING A MECHANICAL PROSTHESIS WITH A 27MM SJM MECHANICAL HEART VALVE. COMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED PERIOPERATIVELY. ON POST-OPERATIVE DAY 13. SHE DEVELOPED HEMOGLOBINURIA MID ANEMIA WITH ELEVATED SERUM TOTAL BILIRUBIN AND LACTIC DEHYDROGENASE LEVELS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED TRIVIAL TRANSVALVULAR LEAKAGE. LABORATORY TEST SUCCESSFULLY IDENTIFIED ANOTHER IRREGULAR ANTIBODY, ANTI-JKB ANTIBODY. THE PATIENT HAD A JKB NEGATIVE BLOOD TRANSFUSION. AND DID NOT NEED RE-OPERATION. LATER. SHE RECOVERED WITH NO SIGNS OF HEMOLYSIS. THE ARTICLE CONCLUDED THAT SINCE ANTI­-JK1'ANTIBODY GETS UNDETECTABLE WITHIN A FEW MONTHS, IT IS DIFFICULT TO FIND OUT BEFORE SURGERY. AS HEMOLY­SIS FOLLOWING CARDIAC SURGERY IS MORE COMMONLY ASSOCIATED WITH PROSTHESES AND

  Patient problems: Hemolytic Anemia; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 14164553 ↗
• InjuryJan 18, 2022Obstruction of Flow; Biocompatibility; Obstruction of Flow; Biocompatibility

  IT WAS REPORTED DURING A FOLLOW-UP IN THE CLINIC THE PATIENT PRESENTED SHORTNESS OF BREATH AND CHEST PAIN. UPON FURTHER EVALUATION, IT WAS DISCOVERED THE PATIENT HAD A "STUCK" VALVE DUE TO THROMBUS FORMATION. THE CAUSE OF THE THROMBUS FORMATION IS DUE TO THE PATIENTS NON-COMPLIANCE WITH THEIR PRESCRIBED ANTICOAGULANT THERAPY. THE PATIENT HAS ALSO NOT HAD THEIR INR FOLLOWED AS REQUIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ON (B)(6) 2021, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE AND IT WAS REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13286385 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED OM (B)(6) 2021, A 30MM SJM RIGID SADDLE RING WAS IMPLANTED. AFTER PLACING THE RING, THERE WAS STILL TOO MUCH OF A LEAK AND IT WAS DECIDED TO DO A VALVE REPLACEMENT. THE PATIENT SUFFERED FROM MITRAL VALVE INSUFFICIENCY AND THE NATIVE VALVE WAS AFFECTED WITH RHEUMATIC FEVER. 27MM SJM MASTER SERIES MECHANICAL VALVE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2021. NO LEAKAGE WAS NOTED AFTER THE MITRAL VALVE REPLACEMENT WAS PERFORMED. LATER, THE PATIENT EXPERIENCED DECREASE VISION IN THE RIGHT EYE. NO DIPLOPIA OR HEMIANOPIA WAS REPORTED AND CAUSE COULD NOT BE CONCLUDED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED TO THE REFERRING HOSPITAL ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING POST OPERATIVE ANEMIA AND WAS TRANSFUSED. THE PATIENT DOES NOT HAVE A HISTORY OF ANEMIA. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. (B)(4). RELATED MANUFACTURER REPORT NUMBER: 3007113487-2022-00020.

  Patient problems: Anemia

  MAUDE report 13260588 ↗
• InjuryJul 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATED ED: IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT UNDERWENT AN EXPLANT OF THEIR 27 MM, SJM MASTERS SERIES MECHANICAL HEART VALVE ON (B)(6) 2021. THE REASON FOR THE EXPLANT IS UNKNOWN AND THE DEVICE (S/N (B)(4)) HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. THREE MONTHS LATER, ON (B)(6) 2021, THE PATIENT REQUIRED ANOTHER RE-DO MITRAL VALVE REPLACEMENT (MVR) AND THE SECOND 27 MM, SJM MASTERS SERIES MECHANICAL HEART VALVE (S/N (B)(4)) WAS EXPLANTED. THE NEED FOR EXPLANT THREE MONTHS POST IMPLANT REMAINS UNKNOWN, HOWEVER. THE PATIENTS PRE-EXPLANT INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.4 UNITS. THROMBUS WAS FOUND INSIDE THE LEAFLET HINGE WHICH APPEARED TO BE IMPEDING THE LEAFLETS ABILITY TO OPEN AND CLOSE, CAUSING THE LEAFLETS TO STICK. THE PATIENTS CONDITION MAY HAVE ALSO PLAYED A ROLE. THE SECOND SJM MASTERS SERIES MECHANICAL HEART VALVE, (S/N (B)(4)) WILL BE RETURNING FOR ANALYSIS. A FULL MULTIFACETED INVESTIGATION HAS BEEN REQUESTED FROM THE IMPLANTING PHYSICIAN. NO FURTHER INFORMATION HAS BEEN PROVIDED. RELATED MANUFACTURER REFERENCE #2648612-2021-00068.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 12118585 ↗
• DeathJul 5, 2021Obstruction of Flow; Biocompatibility; Obstruction of Flow; Biocompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE (S/N (B)(6)) WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT UNDERWENT AN EXPLANT OF THE 27 MM, SJM MASTERS SERIES MECHANICAL HEART VALVE. THE REASON FOR THE EXPLANT IS UNKNOWN. UPON EXPLANT OF THE VALVE, PANNUS HAD BEEN OBSERVED. A REPLACEMENT 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE (S/N (B)(6)) WAS IMPLANTED. THREE MONTHS LATER, ON (B)(6) 2021, THE PATIENT REQUIRED RE-DO MITRAL VALVE REPLACEMENT (MVR) AND THE 27 MM, SJM MASTERS SERIES MECHANICAL HEART VALVE (S/N (B)(6)) WAS EXPLANTED. THE NEED FOR EXPLANT THREE MONTHS POST IMPLANT REMAINS UNKNOWN. THE PATIENTS PRE-EXPLANT INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.4 UNITS. THROMBUS WAS FOUND INSIDE THE LEAFLET HINGE WHICH APPEARED TO BE IMPEDING THE LEAFLETS ABILITY TO OPEN AND CLOSE, CAUSING THE LEAFLETS TO STICK. THE PATIENT'S CONDITION MAY HAVE ALSO PLAYED A ROLE, HOWEVER, THE PHYSICIAN CONFIRMS THE PATIENT DID NOT HAVE A HISTORY OF COAGULATION ISSUES SUCH AS PROTEIN DEFICIENCIES, CANCER OR SMOKING ETC. AN EPIC STENTED PORCINE HEART VALVE WAS IMPLANTED DURING THE PROCEDURE AND WAS NOTED TO HAVE BEEN FUNCTIONING PROPERLY. SUBSEQUENT TO THE INI

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Low Cardiac Output; Mitral Valve Insufficiency/ Regurgitation; Pneumonia; Thrombosis/Thrombus

  MAUDE report 12118349 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER REPORT NUMBER: 2648612-2020-00100. ON (B)(6) 2016, A 27MM MECHANICAL MITRAL VALVE AND A 21MM MECHANICAL AORTIC VALVE WAS IMPLANTED TO REPLACE AN UNKNOWN TISSUE VALVE THAT WAS IMPLANTED IN 2011. THE PATIENT HAS A HISTORY OF ENDOCARDITIS, SYSTEMIC SEPTIC EMBOLI, CARDIOMYOPATHY, HYPERTENSION, SMOKING, PULMONARY HYPERTENSION, BICUSPID AORTIC VALVE AND MODERATE ENLARGEMENT OF ASCENDING AORTA. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT MAY HAVE ENDOCARDITIS AND THAT THERE IS A PLANNED INTERVENTION TO REPLACE THE AORTIC VALVE DUE TO STENOSIS. THERE IS A POSSIBILITY THAT THE MITRAL VALVE WILL BE REPLACED AS WELL.

  Patient problems: Endocarditis

  MAUDE report 10631749 ↗
• InjuryJun 25, 2020Biocompatibility; Biocompatibility

  ON (B)(6) 2020 A SJM MASTER SERIES MECHANICAL HEART VALVE WAS IMPLANTED IN THE PATIENTS MITRAL POSITION. ON (B)(6) 2020 THE SJM MASTER'S SERIES MECHANICAL HEART VALVE WAS EXPLANTED DUE TO THROMBUS. A 27 MM EPIC STENTED PORCINE HEART VALVE W/ FLEXFIT SYSTEM WAS THOUGHT TO BE IMPLANTED AS A REPLACEMENT. WARFARIN HAS BEEN PRESCRIBED TO THE PATIENT, BUT THE INTERNAL MEDICINE DEPARTMENT AT THE HOSPITAL KEPT THE PATIENT'S PROTHROMBIN TIME-INTERNATIONAL NORMALIZED RATIO(PT-INR) RATHER LOW AT 1.49 FOR THE DIALYSIS PATIENT. THE PATIENT'S FIBRINOGEN WAS 690MG/DL AND THE PLT(PLATELET) WAS 500,000¿L; THE PATIENT SEEMED TO HAVE HAD THROMBOGENESIS TENDENCY WHICH MIGHT HAVE BEEN DUE TO CHOLECYSTITIS INFLAMMATION. THE PATIENT IS STABLE.

  Patient problems: Thrombus

  MAUDE report 10195128 ↗
• MalfunctionAug 9, 2019Gas/Air Leak; Gas/Air Leak

  ON (B)(6) 2019, A 27 MM VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT PROCEDURE THE PHYSICIAN NOTED THAT THE VALVE COULD NOT COMPLETELY OPEN. THE VALVE WAS EXCHANGED FOR A 27 MM VALVE FROM MEDTRONIC AND A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE TIME WAS REPORTED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879179 ↗
• InjuryJun 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, A 27MM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED THE PHYSICIAN USED THE HOLDER TO ROTATE THE LEAFLETS AND ONE LEAFLET FELL OFF FROM THE VALVE. THE VALVE WAS REMOVED AND EXCHANGED FOR ANOTHER 27MM MASTERS SERIES MECHANICAL HEART VALVE. EXTENDED PROCEDURE WAS REPORTED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726603 ↗
• InjuryApr 29, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2019, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. AFTER POSITIONING, THE POSTERIOR LEAFLET ALTERNATED BETWEEN MOBILE AND IMMOBILE. THE ANTERIOR NATIVE LEAFLET HAD BEEN COMPLETELY RESECTED, AND THE POSTERIOR NATIVE LEAFLET WAS DIMINUTIVE BUT IMBRICATED IN THE PLEDGETED SUTURES. THERE WAS NO VISIBLE TISSUE ON EITHER SIDE OF THE VALVE WHICH MIGHT HAVE CAUSED THE MASTERS LEAFLET IMMOBILITY. THE MASTERS VALVE WAS EXPLANTED, AND A TISSUE VALVE WAS IMPLANTED (MODEL UNKNOWN). EX VIVO, THE LEAFLETS WERE STILL IMMOBILE AND HAD TO BE FORCED MANUALLY IN ORDER TO MOVE. PER REPORT, THE BYPASS TIME WAS EXTENDED, AND THE PATIENT IS REPORTED TO BE RECOVERING.

  Patient problems: No Information

  MAUDE report 8561738 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 27MM MASTERS MECHANICAL VALVE WAS SELECTED FOR IMPLANT. AFTER THE AORTIC CROSS-CLAMP WAS REMOVED, THE LEFT VENTRICULAR WALL WAS CONFIRMED TO BE BLEEDING. THE TEAR WAS LOCATED NEAR THE NATIVE ANNULUS, ABOUT 5-10MM BELOW THE NATIVE ANNULUS. THE TEAR WAS SURGICALLY CLOSED. A SMALL PERFORATION WAS ALSO OBSERVED. THE USER REPORTED THAT THE BLEEDING COULD BE DUE TO IMPLANT OF TOO LARGE SIZE OF THE VALVE, OR MAYBE CAUSED BY UNCONSCIOUS DAMAGE DURING THE PROCEDURE. THE 27MM WAS EXPLANTED AND A 25MM MASTERS WAS IMPLANTED. THE PATIENT IS REPORTED TO BE RECOVERING.

  Patient problems: Cardiac Perforation

  MAUDE report 8526805 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS INITIALLY REPORTED THAT THE REPORTED VALVE WAS EXPLANTED AFTER AN IMPLANT PERIOD OF ABOUT 3 MONTHS. BASED ON A FOLLOW-UP CONVERSATION WITH THE PHYSICIAN, IT WAS CONFIRMED THAT THIS 27MM VALVE WAS SELECTED FOR IMPLANT, BUT DETERMINED TO BE THE INCORRECT SIZE. AS THE DEVICE WAS EXCHANGED THE DEVICE FELL ONTO THE FLOOR. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THE REPORTED DEVICE WAS NEVER IMPLANTED IN THE PATIENT.

  Patient problems: Mitral Regurgitation; No Consequences Or Impact To Patient; Thrombus

  MAUDE report 8404667 ↗
• InjuryFeb 27, 2019Fracture; Fracture

  ON (B)(6) 2019, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT. WHILE TESTING THE VALVE AFTER IMPLANTATION, A METALLIC PIECE WAS OBSERVED TO BE DETACHED. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 27MM MASTERS VALVE (SERIAL NUMBER: UNKNOWN). THE PROCEDURE WAS EXTENDED 30 MINUTES. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374425 ↗
• InjuryJan 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2012, A MITRAL VALVE REPLACEMENT (MVR) WAS PERFORMED AND THIS 27MM MASTERS VALVE (MODEL NUMBER: 27MJ-501, SERIAL NUMBER: (B)(4)) WAS IMPLANTED IN THE PATIENT'S MITRAL POSITION. ON (B)(6) 2018, RE-DO MVR WAS PERFORMED AND THIS VALVE WAS EXPLANTED DUE TO INFECTIVE ENDOCARDITIS (IE). DURING EXPLANT PROCEDURE, THE PATIENT'S NATIVE MITRAL ANNULUS WAS NOTED TO HAVE DISRUPTED AND THE 27MM MASTERS VALVE WAS ABOUT TO BE DETACHED FROM THE ANNULUS. A SECOND 27MM MASTERS VALVE (MODEL NUMBER: 27MJ-501, SERIAL NUMBER: (B)(4)) IMPLANTED IN THE MITRAL POSITION; HOWEVER, WHEN THE SECOND 27MM MASTERS VALVE WAS ATTEMPTED TO ROTATE USING THE HOLDER HANDLE, BOTH LEAFLETS DISLODGED FROM THIS VALVE. THE SECOND 27MM MASTERS VALVE WAS EXPLANTED AND THE DISLODGED LEAFLETS WERE ENTIRELY REMOVED FROM THE PATIENT. A 25MM MASTERS SERIES MECHANICAL HEART VALVE (MODEL NUMBER: 25MJ-501, SERIAL NUMBER: (B)(4)) WAS THEN IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT'S POSTOPERATIVE COURSE WAS UNEVENTFUL. PER THE USER, THE PROCEDURE WAS EXTENDED. PER REPORT, THE PATIENT HAD A DENTAL CAVITY P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8229703 ↗