SJM™ Masters Series 15MHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067016522), received between Aug 13, 2018 and Apr 2, 2021 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2021Backflow; Insufficient Device Problem Information; Backflow; Insufficient Device Problem Information

  ON (B)(6) 2021, A 15MM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS RECEIVED BY ABBOTT. THE VALVE APPEARED TO HAVE BEEN EXPLANTED AND HAD TISSUE RETAINED UPON ARRIVAL. THE PATIENT WAS REPORTED TO HAVE DISCHARGED IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED ON 30 MARCH 2021 REPORTED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2016 AND EXPLANTED ON (B)(6) 2021 DUE TO AORTIC INSUFFICIENCY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11610817 ↗
• DeathOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD RECEIVED A 15 MM MASTERS AORTIC VALVE AND A 15MM AND 17MM MASTERS MITRAL VALVE DIED ON (B)(6) 2020 OF UNKNOWN CAUSES. AS THERE IS NOT ENOUGH INFORMATION TO DETERMINE RELATION TO THE ABBOTT DEVICES, THIS EVENT IS BEING CONSERVATIVELY REPORTED. ON (B)(6) 2017 A 15MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE MITRAL VALVE WAS IMPLANTED. ON (B)(6) 2017 THE PATIENT UNDERWENT AN IMPLANT PROCEDURE OF A 15 MM AORTIC VALVE, 15 AHPJ-505. POST IMPLANT, IN 2018, THE PATIENT WAS TREATED FOR A VARIETY OF COMORBIDITIES INCLUDING "FAILURE TO THRIVE" REQUIRING A FEEDING TUBE, C-DIFF INFECTION AND RECURRENT BRONCHIOLITIS. ON (B)(6) 2020, THE 15 MM MASTERS VALVE WAS EXCHANGED WITH A 17 MM SJM MASTERS SERIES HEMODYNAMIC PLUS MITRAL VALVE. SINCE THE IMPLANT OF THE 17MM VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK, SUFFERED CARDIAC ARREST, A SUBDURAL HEMATOMA, SEVERE RENAL FAILURE, PANCREATITIS AND BACTERIAL PNEUMONIA. ON (B)(6) 2020 THE PATIENT WAS BROUGHT IN FOR AN UNRELATED PROCEDURE WHICH IDENTIFIED AN "OBSTRUCTED CIRCUMFLEX ARTERY." IT WAS DETERMINED THE OBSTRUCTION WAS SECONDARY TO COMPRESSION OF THE 17MM MITRAL VALVE. THE SITE REPORTED THE PATIENT¿S DEAT

  Patient problems: Death

  MAUDE report 10722336 ↗
• InjuryJul 28, 2020Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2017, A 15MM MASTERS MITRAL VALVE WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED FOR PLANNED MITRAL VALVE REPAIR DUE TO WORSENING MITRAL VALVE STENOSIS AND PULMONARY HYPERTENSION. ON (B)(6) 2020, THE MITRAL VALVE WAS EXPLANTED AND A NEW 17MM MASTERS MITRAL VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, THE PATIENT DEVELOPED FIRST DEGREE HEART BLOCK, COMPLETE HEART BLOCK, AND JUNCTIONAL RHYTHM. THEREFORE, ON (B)(6) 2020, AN EPICARDIAL PACEMAKER WAS IMPLANTED. THE PATIENT IS REPORTED TO BE RECOVERING. CLINICAL STUDY PATIENT ID: (B)(6).

  Patient problems: High Blood Pressure/ Hypertension; Mitral Valve Stenosis

  MAUDE report 10333041 ↗
• InjuryJan 7, 2020Obstruction of Flow; Biocompatibility; Obstruction of Flow; Biocompatibility

  AFTER MHV IMPLANTATION ON (B)(6) 2019 OF A 15MHPJ-505 (SN (B)(4)) UNDER COMPASSIONATE USE (BEFORE CE MARK), IT WAS DETECTED ON (B)(6) 2019 A BLOCK IN ONE OF THE LEAFLETS (NOT MOVING), AFTER DETECTION OF LOW PATIENT OUTPUT AND INCREASE OF GRADIENTS. ANTITHROMBOTIC THERAPY WAS INTRODUCED WITHOUT SUCCESS FACING A POSSIBLE THROMBUS. THE PATIENT WASN'T UNDER AC SINCE INTERVENTION BECAUSE OF VERY YOUNG AGE AND MULTIPLE COMORBIDITIES. THE PATIENT HAD BEEN UNDER LOW MOLECULAR WEIGHT HEPARYN. THE PATIENT HAS HAD LOT OF CONCOMITANT INFECTIONS DUE TO COMORBIDITIES. SURGEONS SUSPECT ON ENDOCARDITIS. THE PROSTHESIS HAS BEEN EXPLANTED TODAY ((B)(6)) AND SENT BY THE SURGEONS TO THE MICROBIOLOGY LAB AT THEIR HOSPITAL FOR ANALYSIS. THEY HAVE IMPLANTED ANOTHER ABBOTT 15MMS.

  Patient problems: Endocarditis; Low Cardiac Output

  MAUDE report 9557902 ↗
• InjuryApr 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2017, A 15MM MASTERS PLUS VALVE WAS IMPLANTED IN A PEDIATRIC PATIENT. ON (B)(6) 2019, THE 2 YEAR OLD VALVE WAS EXPLANTED AND REPLACED WITH A LARGER 19MM MASTERS MECHANICAL HEART VALVE (SERIAL NUMBER: (B)(4)) DUE TO PATIENT GROWTH. THE PATIENT IS REPORTED TO BE STABLE. (CLINICAL STUDY PATIENT ID: (B)(6)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8489745 ↗
• InjuryJan 22, 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) 2017, A 15MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION AS PART OF THE US CLINICAL STUDY. ON (B)(6) 2019, ABBOTT CLINICAL AFFAIRS WAS INFORMED THAT THE DEVICE WAS EXPLANTED. THE PATIENT'S CLINICAL RECORDS WERE RECEIVED AND IDENTIFIED THE PATIENT, A TODDLER WITH COMPLEX MEDICAL HISTORY CONSISTING OF: SHONE SYNDROME, PULMONARY HYPERTENSION, FAILURE TO THRIVE, LV HYPERTROPHY. PAST SURGICAL HISTORY INCLUDES: MITRAL VALVE REPAIR (2016), MULTIPLE AORTIC BALLOON VALVULOPLASTIES, MVR (15MM MITRAL VALVE), SUB-AORTIC RESECTION, AND RESECTION OF LEFT VENTRICULAR FIBROSIS AND MUSCLE BUNDLES. THE ECHOCARDIOGRAM FINDINGS DETERMINED THE GRADIENT ACROSS THE IMPLANTED MITRAL VALVE WAS DUE TO THE SOMATIC GROWTH OF THE SUBJECT; THERE WAS NO ALLEGED DEFICIENCY WITH THE MASTERS VALVE. THE VALVE WAS EXPLANTED ON (B)(6) 2018, AND SUCCESSFULLY REPLACED WITH A 19MM MASTERS VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. (EC0000-681-022, HALO: US-3902).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267706 ↗
• InjuryNov 7, 2018Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2017, A 15MM SJM MASTERS SERIES VALVE WAS IMPLANTED. THE PATIENT WAS NOT DOING WELL, AND ON (B)(6) 2017, WENT FOR A CATH THAT SHOWED SEVERE PERIVALVAR LEAK IN THE MITRAL VALVE. BOTH LEAFLETS HAD ADEQUATE EXCURSION, BUT THE SUPERIOR/RIGHT LEAFLET EXCURSION WAS LESS THAN THE LEFT/INFERIOR OF THE VALVE. A MITRAL VALVE REPLACEMENT WAS PLANNED, BUT IT WAS REPORTED THAT THE VALVE WAS NOT EXPLANTED. THE PHYSICIAN WAS ABLE TO SEE THE VALVE IN THE PROXIMAL AREA WHERE THE LEAK WAS SEEN ON ECHO, SO HE BOLSTERED THE ENTIRE LEFT LATERAL SIDE WITH 5-0 PLEDGETTED SUTURES ALONG THE ENTIRE AREA. POST PROCEDURE THERE WAS NO LEAK OBSERVED. ON 19 OCTOBER 2018, ABBOTT WAS NOTIFIED THAT THE VALVE WAS EXPLANTED (B)(6) 2018 WHICH WAS ANTICIPATED DUE TO PATIENT GROWTH. A 17 MM VALVE WAS IMPLANTED. (CLINICAL STUDY PATIENT ID: (B)(6))

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046234 ↗
• DeathAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A 15MM MECHANICAL HEART VALVE WAS IMPLANTED IN A (B)(6) BORN WITH COMPLEX CONGENITAL HEART DISEASE CONSISTING OF A DOUBLE OUTLET RIGHT VENTRICLE AND CORONARY ANOMALY. PRIOR SURGICAL INTERVENTIONS INCLUDED VENTRICULAR DEFECT CLOSURE, ARTERIAL SWITCH PROCEDURE AND MITRAL VALVULOPLASTY. THE PATIENT REMAINED HOSPITALIZED IN THE INTENSIVE CARE UNIT. FOLLOWING THE VALVULOPLASTY, THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT DUE TO THE PRESENCE OF SEVERE MITRAL INSUFFICIENCY AS AN ATTEMPT TO SAVE THE (B)(6) LIFE. POST-PROCEDURE, THE PATIENT REMAINED PERSISTENTLY UNSTABLE AND IN THE ICU ON INOTROPES. ON (B)(6) 2018, THE PATIENT DIED DUE TO THE CLINICAL CONDITIONS OF THE PATIENT AND NOT AS A RESULT OF THE PERFORMANCE OF THE DEVICE.

  Patient problems: Death

  MAUDE report 7779482 ↗