SJM™ Masters Series 27MECJ-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734006453), received between Oct 1, 2018 and Apr 6, 2023 — classified as 3 deaths, 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANTATION INTO A PATIENT. DURING THE PROCEDURE, DURING IMPLANTATION, A LEAFLET DISLODGED FORM THE DEVICE, FRACTURED INTO TWO PIECES, AND FELL INTO THE LEFT VENTRICLE. THE LEAFLET PIECES WERE RETRIEVED, AND THE VALVE WAS REPLACED WITH A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF. IT WAS REPORTED THAT THE PATIENT IS STABLE. 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 16691926 ↗
• DeathDec 24, 2021Biocompatibility; Biocompatibility

  THIS EVENT IS BEING CONSERVATIVELY REPORTED FOR THE PATIENT'S DEATH AS THE DATE AND CAUSE OF THE PATIENT'S DEATH WAS UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2021, A 27 MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED FOR A MITRAL VALVE REPLACEMENT. DURING A FOLLOW-UP VISIT IN (B)(6) 2021, THE PATIENT WAS IDENTIFIED WITH HAVING A PROSTHETIC VALVE THROMBOSIS EPISODE. THE PATIENT WAS RE-ADMITTED FOR THROMBOLYTIC THERAPY. IT WAS ALSO REPORTED THAT THE PATIENT DIED ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13085472 ↗
• InjuryDec 22, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, A 27 MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED. DURING THE PATIENTS FOLLOW-UP, ON AN UNKNOWN DATE, PROSTHETIC VALVE THROMBOSIS WAS NOTED. THE PATIENT WAS TREATED WITH THROMBOLYTIC THERAPY TO RESOLVE THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13061137 ↗
• InjuryDec 21, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED A PATIENT UNDERWENT AN IMPLANT OF A 27MM, SJM MASTERS SERIES VALVE EXPANDED CUFF MITRAL VALVE ON (B)(6) 2021. DURING A FOLLOW-UP IN THE CLINIC, THE PATIENT PRESENTED WITH A SEVERE MURMUR. FURTHER TESTING REVEALED THE PATIENT HAD A THROMBOSIS ON THEIR PROSTHETIC VALVE. THE PATIENT WAS TREATED WITH THROMBOLYTIC THERAPY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052923 ↗
• InjuryJun 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ON (B)(6) 2018, A 21MM SJM REGENT HEART VALVE W/FLEX CUFF WAS IMPLANTED IN THE AORTIC POSITION AND A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED IN THE MITRAL POSITION DUE TO ENDOCARDITIS. ON (B)(6) 2021, BOTH VALVES WERE EXPLANTED DUE UNKNOWN SYMPTOMS THE PATIENT PRESENTED WITH AND THE ANTIBIOTICS THAT WERE GIVEN. THE PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT CANNOT BE OBTAINED. MANUFACTURER REPORT NUMBER: 2648612-2021-00065.

  Patient problems: Endocarditis

  MAUDE report 11990461 ↗
• InjuryJan 19, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2020, A PATIENT UNDERWENT A DOUBLE VALVE REPLACEMENT (DVR) USING A 27 MM MASTERS SERIES VALVE (MECJ) IN THE MITRAL POSITION AND A 19 MM MASTERS SERIES VALVE (AECJ ) IN THE AORTIC POSITION. DURING THE POST-OPERATIVE OBSERVATION THE PHYSICIAN FOUND A MODERATE TO SEVERE PARAVALVULAR LEAKAGE AROUND THE SEWING RING. THE PHYSICIAN DECIDED TO RE-IMPLANT THE MITRAL VALVE WITH A NEW PROSTHESIS. THE PATIENT DID NOT EXPERIENCE ANY SERIOUS INJURIES. THE 27 MM MITRAL VALVE WAS CAREFULLY EXPLANTED FROM THE PATIENT AND A NEW 27 MM MASTERS SERIES VALVE (MECJ) WAS IMPLANTED IN THE MITRAL POSITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11194748 ↗
• DeathFeb 26, 2020Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  ON (B)(6) 2020, A 27MM MASTERS SERIES VALVE WAS IMPLANTED WITHOUT ANY INCONVENIENCES AND THE PATIENT WAS REPORTED STABLE POST IMPLANT. AFTER MOVING THE PATIENT TO RECOVERY ON (B)(6) 2020, THE PATIENT SUFFERED HEMODYNAMIC DECOMPENSATION. AN ECHOCARDIOGRAM WAS PERFORMED AND THE PHYSICIAN DECIDED TO RE-OPERATE. ON (B)(6) 2020, DURING RE-OPERATION IT WAS NOTED THAT ONE OF THE LEAFLETS HAD DISLODGED AND THE OTHER LEAFLET COULD NOT BE FOUND. ANOTHER 27MM MASTERS SERIES VALVE WAS IMPLANTED AND THE PATIENT WAS MOVED TO RECOVERY. ON (B)(6) 2020, THE PATIENT HAD EXPIRED AND IT IS UNKNOWN IF THE VALVE LED TO THE PATIENT'S DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT CANNOT BE OBTAINED.

  Patient problems: Death

  MAUDE report 9756609 ↗
• InjurySep 17, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2017, A 27MM MASTERS SERIES VALVE WAS IMPLANTED. ON (B)(6) 2019, THE VALVE WAS EXPLANTED DUE TO LEAFLET OBSTRUCTION AND THE VALVE WAS EXCHANGED WITH A 27MM EPIC STENTED PORCINE VALVE. THE PATIENT HAS BEEN DISCHARGED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075774 ↗
• InjurySep 10, 2019Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  (B)(6) 2019 JL: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THAT PIECES OF THE VALVE WERE CONFIRMED TO BE REMOVED. A 25MM MASTERS VALVE WAS SUCCESSFULLY IMPLANTED. THE USER DOES NOT ALLEGE A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME AND THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ON (B)(6) 2019, A 27MM MASTERS MECHANICAL VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, ONE OF THE LEAFLETS BROKE AS THE PHYSICIAN WAS ROTATING THE VALVE. THE PATIENT IS RECOVERING. ATTEMPT TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8981573 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, A 21MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2019, STRUCTURAL VALVE DETERIORATION WAS DETECTED. ON 16 JANUARY 2019 THE TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH A 19MM CARBOMEDICS PROSTHESIS (MODEL NUMBER: UNKNOWN). NO PATIENT CONSEQUENCES WERE REPORTED. (CLINICAL STUDY PATIENT ID (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8682530 ↗
• DeathApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SEVENTEEN YEARS AGO, A PATIENT RECEIVED A 19MM MECHANICAL HEART VALVE (MANUFACTURER UNCONFIRMED) IN THE MITRAL POSITION. THE PATIENT WAS DIAGNOSED WITH SEVERE MITRAL STENOSIS, ATRIAL FLUTTER AND PULMONARY HYPERTENSION. ON (B)(6) 2019, A 27MM MASTERS VALVE (SN: (B)(4)) WAS SELECTED AS A REPLACEMENT. THE PATIENT WAS STARTED ON ECMO SUPPORT VIA FEMORAL ACCESS DUE TO PULMONARY EDEMA. ON (B)(6) 2019, CLOTTING IN THE PLURAL SPACE WAS NOTED AND THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM. IN THE OPERATING ROOM, THE LEAFLET WAS OBSERVED TO HAVE DISLODGED AND WAS PRESSED AGAINST THE AORTIC VALVE ON THE ASCENDING AORTA SIDE. THE VALVE WAS REMOVED AND THE PIECE WAS COLLECTED AND A NEW 27MM MASTERS VALVE (SN: (B)(4)) WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death; Pulmonary Edema

  MAUDE report 8476051 ↗
• InjuryMar 29, 2019Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  ON (B)(6) 2019, A 27MM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. DURING POSITIONING, A LEAFLET FRACTURED. THE VALVE WAS REMOVED AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE AND BYPASS WERE REPORTED AS EXTENDED A CLINICALLY SIGNIFICANT TIME (15 MINUTES) WHILE EXCHANGING THE VALVE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. ANOTHER 27MM MASTERS VALVE WAS IMPLANTED SUCCESSFULLY AND POST-OPERATIVELY, THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464690 ↗
• InjuryFeb 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 27MM MASTERS VALVE WAS SELECTED FOR IMPLANT. AFTER IMPLANT, THE SURGEON OBSERVED THAT A DISC OF THE PROSTHESIS BECAME DISLODGED AFTER ROTATION. THE LEAFLET WAS RETRIEVED AND THE VALVE WAS EXPLANTED. A SECOND 27MM MASTERS VALVE WAS IMPLANTED. PER THE USER, THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, BUT POST-OPERATIVELY, THE PATIENT REMAINED IN THE ICU LONGER AND MORE ISCHEMIA TIME (BYPASS TIME) WAS REFLECTED DUE TO THE NEED FOR ADDITIONALLY VASOPRESSORS AND INOTROPIC DRUGS. THE PATIENT IS REPORTED TO BE STABLE AND DISCHARGED.

  Patient problems: Ischemia

  MAUDE report 8342075 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A MITRAL VALVE REPLACEMENT PROCEDURE, A 27 MM MASTERS SERIES MITRAL VALVE WAS ATTEMPTED TO BE ROTATED WITH THE SJM HOLDER AND ONE LEAFLET DISLODGED FROM THE BUTTERFLY HINGE AND GOT STUCK WITHIN THE HOUSING OF THE VALVE. THE VALVE WAS EXPLANTED AND REPLACED WITH A SMALLER 25 MM MASTERS SERIES MITRAL VALVE. CPB TIME WAS EXTENDED FOR 30 MINUTES DUE TO THIS EVENT; HOWEVER, THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7923490 ↗