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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067016515), received between Dec 19, 2019 and Dec 12, 2022 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Device Stenosis” (1 report).

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.

• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Device Stenosis; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED THAT IN (B)(6) 2021, A 15MM AORTIC MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED. ON (B)(6) 2022, THERE ARE INCREASED GRADIENT NOTED ON THE VALVE AND A SURGICAL INTERVENTION WAS PLANNED, HOWEVER HAS NOT YET BEEN PERFORMED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 15960255 ↗
• InjuryMar 8, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT WITH CONGENITAL AORTIC STENOSIS AND EPSTEIN ANOMALY UNDERWENT A IMPLANT PROCEDURE OF A 15MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE. ON (B)(6) 2021 STRUCTURAL VALVE DETERIORATION WAS REPORTED. ONE OF THE POSTERIOR LEAFLETS WAS NOT MOVING. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. THE LEAFLET WAS STILL NOT MOVING AT THE TIME OF DISCHARGE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 11FEB22 PM. (B)(4) - 15MM SURGICAL AORTIC VALVE PAS, (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697906 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 15MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS IMPLANTED (B)(6) 2021. IMMEDIATELY POST OPERATIVELY, THE PATIENT HAD INCREASED CHEST TUBE OUTPUT AND THE DECISION WAS MADE TO RE-EXPLORE AT BEDSIDE. A MODERATE MEDIASTINAL HEMATOMA WAS REMOVED. IT WAS NOTED THAT THERE WERE SEVERAL OOZING SITES BUT THERE WAS NO SURGICAL BLEEDING SITES. THE PATIENT RECEIVED FACTOR VII AND THROMBIN. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD A VERY COMPLEX MEDICAL HISTORY AND THEIR HOSPITAL STAY WAS PROLONGED SECONDARY TO THEIR CHRONIC CONDITIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EVENT IS BEING CONSERVATIVELY REPORTED. (B)(4), 15MM SURGICAL AORTIC VALVE PAS, (B)(4).

  Patient problems: Dyspnea; Hematoma; Hypoxia

  MAUDE report 13553286 ↗
• InjuryJan 18, 2022Adverse 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 REPORTED A PATIENT UNDERWENT IMPLANT OF A 15 MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE ON (B)(6) 2019. DURING THE PROCEDURE THE PATIENT BEGAN TO HEMORRHAGE RESULTING IN THE PATIENT REQUIRING PACKED RED BLOOD CELL REPLACEMENT, FACTOR 7 AND A TRANEXAMIC ACID INFUSION. THE PATIENT REMAINED TACHYCARDIC AND WAS MONITORED IN THE CARDIAC INTENSIVE CARE UNIT. ON (B)(6) 2019, THE PATIENT DEVELOPED HYPOXIA DURING THEIR CHEST CLOSURE PROCEDURE. THE PATIENT WAS EXTUBATED ON (B)(6) 2019 AND DEVELOPED A PNEUMOTHORAX POST CHEST TUBE REMOVAL ON (B)(6) 2019. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. US5146-10, CRD_945-SURGICAL AORTIC VALVE PAS, (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286688 ↗
• DeathDec 19, 2019Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2017, A 15MM MASTERS VALVE WAS IMPLANTED. POST IMPLANT PROCEDURE, POST OPERATIVE BLEEDING WAS REPORTED AND THE PATIENT RECEIVED A BLOOD TRANSFUSION. A VALVE THROMBUS WAS ALSO REPORTED AND THE PATIENT WAS PRESCRIBED MEDICATION. ON (B)(6) 2017, THE PATIENT EXPIRED DUE TO NON DEVICE RELATED COMPLICATIONS.

  Patient problems: Death; Thrombus

  MAUDE report 9496800 ↗