SJM™ Masters Series HP 19AHPJ-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734005883), received between Oct 7, 2019 and Oct 26, 2023 — classified as 3 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Incomplete Coaptation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM EPIC PLUS SUPRA WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK OF 8 MMHG AND AVERAGE GRADIENT OF 35 MMHG. A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED AS A REPLACEMENT. POST IMPLANT, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE AND DATE OF THE DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18013991 ↗
• DeathDec 14, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANTATION. PRIOR TO THE PROCEDURE THE PATIENT WAS REPORTED TO BE STABLE. WHILE IMPLANTING THE VALVE, IT WAS NOTED THAT THE LEAFLETS DID NOT OPEN AND CLOSE PROPERLY. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. IT WAS NOTED THAT THERE WAS A PROLONGED PROCEDURE TIME TO PLACE THE NEW VALVE. IT WAS NOTED THAT THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT WAS PUT ONTO INTROPICAL SUPPORT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON AN UNKNOWN DATE DUE TO CHONDROGENIC SHOCK AND HEART FAILURE. DUE TO CHANGING THE VALVE THE PATIENTS PROCEDURE TIME WAS EXTENDED, POSSIBLY CONTRIBUTING TO PATIENT FATALITY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15978878 ↗
• DeathSep 23, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT. IT WAS NOTED THAT DURING PROCEDURE THE LEAFLETS OF THE VALVE WERE NOT COAPTING PROPERLY. THE DECISION WAS MADE TO EXPLANT THE 19MM MASTERS VALVE AND REPLACE IT WITH A 17MM REGENT VALVE. DUE TO AN UNKNOWN REASON THE PATIENT WAS PRONOUNCED DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 15474111 ↗
• MalfunctionMay 7, 2021Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2021, A 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE IT WAS REPORTED THAT THE LEAFLET BROKE WHILE TRYING TO ROTATE THE VALVE. ALL THE PIECES WERE RECOVERED AND A NEW 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE HOWEVER, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789645 ↗
• InjuryOct 7, 2019Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2019, A 19MM MASTERS VALVE WAS SELECTED FOR IMPLANT. AFTER PARACHUTING THE VALVE IT WAS OBSERVED THAT THE LEAFLET WAS NOT OPENING COMPLETELY. THE PATIENT'S NATIVE ANNULUS WAS HEAVILY CALCIFIED WHICH REQUIRED FURTHER DEBRIDEMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE HOWEVER THIS RESULTED IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9164902 ↗