SJM™ Masters Series HP Gelweave Valsalva 21VAVGJ-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734009478), received between Sep 18, 2019 and May 17, 2023 — classified as 2 deaths, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_992 - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. NO CONCOMITANT CARDIAC PROCEDURES WERE PERFORMED DURING THE SAME SURGERY. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES RECORDED. ON 14 MARCH 2023, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED FLUID AND AIR INCLUSION IN STERNAL, RETROSTERNUM, AND AORTIC ROOT. PATIENT HAD PERICARDIAL EFFUSION, MEDIASTINITIS, RETROSTERNAL HEMATOMA, AND RETROSTERNAL INFECTION. THIS WAS BELIEVED TO BE RELATED TO PATIENT'S HISTORY OF A WOUND HEALING DISORDER. PATIENT WAS STARTED ON ANTIBIOTICS. THERE WAS MACROSCOPICALLY SUSPECTED HEMATOMA INFECTION WITH CONTACT TO THE GRAFT, AND NO BACTERIA WAS ISOLATED. THERE WERE NO DIRECT SIGNS OF A GRAFT INFECTION. HOSPITALIZATION WAS PROLONGED. ON CT SCAN, THE STERNUM APPEARED TO BE STABLE. ON (B)(6) 2023, PATIENT HAD RESTERNOTOMY PERFORMED WITH PLEURAL AND PERICARDIAL DRAINAGE. DURING REOPENING, SOME STERNAL FRACTURES WERE OBSERVED. ON 04 APRIL 2023, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON 21 APRIL 2023, THE PATIENT RETURNED WITH STERNAL

  Patient problems: Hematoma; Pericardial Effusion; Unspecified Infection

  MAUDE report 16950401 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_992 - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. NO CONCOMITANT CARDIAC PROCEDURES WERE PERFORMED DURING THE SAME SURGERY. NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES WERE RECORDED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2022, A PLEURAL PUNCTURE WAS PERFORMED DUE TO SUSPECTED HEMATOMA. ON (B)(6) 2022, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A RIGHT SIDED HEMOTHORAX. ON (B)(6) 2022, A VIDEO-ASSISTED THORACIC SURGERY (VATS) WAS PERFORMED TO REMOVE THE HEMATOMA. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Hematoma; Hemothorax

  MAUDE report 16950369 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS. EU0336 - 702 (R751347001, R751348701) IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM MASTERS SERIES¿ HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY (VAVGJ) WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH HYPERTHERMIA DUE TO INFECTION. MEDICATION WAS ADMINISTERED/ADJUSTED. ON (B)(6) 2023, TRANSTHORACIC ECHOCARDIOGRAM SHOWED PERICARDIUM, LOCALIZED PERICARDIAL EFFUSION OPPOSITE THE LATERO- AND POSTERO-VENTRICLE WALL, PROBABLY PARTITIONED AT 17 MM POSTERO- VENTRICLE, 17 MM LATERO-LEFT VENTRICLE, NO REPERCUSSIONS ON THE CARDIAC CHAMBER. A COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6)2023, SHOWED THE APPEARANCE OF AN ABUNDANT PERICARDIAL EFFUSION, MEASURING UP TO 27 MM IN THICKNESS OPPOSITE THE LATERAL WALL OF THE LEFT VENTRICLE. THE PERICARDIAL EFFUSION LEAD TO CARDIAC TAMPONADE MEDICATION WAS ADMINISTERED/ADJUSTED. THE PATIENT WAS ALSO TREATED WITH ENOXAPARIN AN ANTI-THROMBOTIC REGIMEN. ON (B)(6) 2023, THE PATIENT PRESENTED FOR EVACUATION OF THE PERICARDIAL EFFUSION BY MARFAN WITH PLACEMENT OF 2 DRAINS (LATERO LV AND INFERO RV) AND A THORACIC DRAIN. ON (B)(6) 2023, TTE AND CT WAS PERFORMED AND SHOWED PERSISTENT PERICARDIAL EFFUSION. THE

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Unspecified Infection

  MAUDE report 16942902 ↗
• DeathApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6) ; ((B)(4)). IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO THE PATIENT IN AN EMERGENCY SURGERY. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES NOTED. ON (B)(6) 2023, ATELECTASIS OF THE UPPER, MIDDLE, AND LOWER LOBE OF THE RIGHT LUNG WAS OBSERVED. THE PATIENT ALSO HAD BILATERAL PNEUMONIA AND WAS HOSPITALIZED. ON (B)(6) 2023, AN ULTRASOUND CONDUCTED WHICH SHOWED A SMALL PERICARDIAL EFFUSION AND LARGE LEFT PLEURAL EFFUSION WERE FOUND. MEDICATION WAS ADMINISTERED. A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION. A NEUROLOGICAL CONSULTATION DEMONSTRATED THAT THE PATIENT HAD PARALYSIS AND NO REFLEX RESPONSE. ON HEAD CT SCAN, VASCULAR DAMAGE WAS OBSERVED, AND THE CAUSE WAS BELIEVED TO BE DUE TO ACUTE STROKE AND POST-ANOXIC ENCEPHALOPATHY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. IT IS BELIEVED THAT THE ADVERSE EVENTS WERE RELATED TO THE PROCEDURE, NOT RELATED TO THE IMPLANTED DEVICE. THE PATIENT IS REPORTED TO BE STABLE, BUT DID NOT WAKE UP DUE TO POST-ANOXIC ENCEPHALOPATHY. IT WAS REPORTED THAT ON (B)(6) 2023 MEDI

  Patient problems: Encephalopathy; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion; Pleural Effusion; Pneumonia; Stroke/CVA

  MAUDE report 16715706 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. NO CONCOMITANT CARDIAC PROCEDURES WERE PERFORMED. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES. IN THE FIRST POST-OPERATIVE HOURS, EXCESSIVE MEDIASTINAL DRAINAGE WAS OBSERVED DUE TO THE PROCEDURE. THE IMPLANTED VALVE WAS STILL WORKING AS INTENDED, AND THE BLEEDING WAS NOT BELIEVED TO BE RELATED TO A DEVICE ISSUE. DUE TO THE INCREASED DRAINAGE, ANOTHER THORACOTOMY WAS PERFORMED. BLEEDING WAS CONTROLLED. BLOOD CLOTS WERE REMOVED. PATIENT RECEIVED RED BLOOD CELL TRANSFUSION, PLASMA TRANSFUSION, FIBRINOGEN CONCENTRATE, AND TRANEXAMIC ACID. ON (B)(6) 2023, PATIENT RECEIVED ANOTHER BLOOD TRANSFUSION. HOSPITALIZATION WAS PROLONGED. ON (B)(6) 2023, ATRIAL FIBRILLATION WAS NOTED. ANTI-ARRHYTHMIC MEDICATIONS WERE ADMINISTERED. ON (B)(6) 2023, THE PATIENT WAS ADMITTED DUE TO MOBILITY OF THE STERNUM AND THE LEAKAGE OF SERIOUS CONTENT FROM THE WOUND. AFTER ANTIBIOTIC PREPARATION AND OBTAINING STERILE CULTURES, THE STERNOTOMY WOUND WAS CLEANED AND SUTURED ON (B)(6) 2023. THE PATIEN

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 16710637 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL TRIAL : (B)(4). PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE PATIENT EXPERIENCED NON-ST-ELEVATION MYOCARDIAL INFARCTION IN 2 VESSEL CORONARY ARTERY DISEASE. A PERCUTANEOUS INTERVENTION (ANGIOPLASTY/STENT) WAS PERFORMED. THE PHYSICIAN ALLEGE THAT MYOCARDIAL INFARCTION WAS CAUSED BY PROXIMAL STENOSIS OF THE VENOUSINTERPONAT. THE DEVICE WAS REPORTED TO BE WORKING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Myocardial Infarction

  MAUDE report 15812542 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 12 APRIL 2022, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. A CORONARY ARTERY BYPASS GRAFT (CABG), A MITRAL VALVE REPAIR, AND A TRICUSPID VALVE REPAIR WERE ALSO PERFORMED DURING THE SAME SURGERY. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS NOTED. ON 13 APRIL 2022, LABORATORY ANALYSIS SHOWED LACTATEMIA, AND PATIENT'S LACTATE WAS 61MG/DL. ON 14 APRIL 2022, THE PATIENT EXPERIENCED HEMODYNAMICALLY RELEVANT BRADYCARDIC ATRIAL FIBRILLATION ON ELECTROCARDIOGRAM (EKG). THE PATIENT THEN HAD INTERMITTENT TACHYCARDIC ATRIAL FIBRILLATION. CARDIOVERSION WAS PERFORMED TWICE WITHOUT SUCCESS. ON 24 APRIL 2022, THE PATIENT WAS NOTED TO HAVE BILATERAL PLEURAL EFFUSION LEADING TO TACHYPNEA AND DYSPNEA. A THORACENTESIS WAS REQUIRED, AND THE PATIENT WAS TEMPORARILY TRANSFERRED BACK TO THE INTENSIVE CARE UNIT (ICU). THE ANTIARRHYTHMIC AMIODARONE WAS ADMINISTERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Dyspnea

  MAUDE report 14414764 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT WAS IMPLANTED. ON THE MORNING OF (B)(6) MARCH 2022, THE PATIENT WENT INTO SUDDEN VENTRICULAR FIBRILLATION, CARDIAC ARREST. THE PATIENT WAS ON DOPAMINE AND ADRENALINE INFUSION, UNSTABLE AND HAD CIRCULATORY INSUFFICIENCY. RESUSCITATION WAS PERFORMED. PATIENT WAS GIVEN MEDICATION AND DEFIBRILLATED ONCE WHICH WAS EFFECTIVE, WITH A STABLE RHYTHM. ONE UNIT OF PACKED RED BLOOD CELLS WAS TRANSFUSED. THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE CAUSE OF THE CARDIAC ARREST WAS DUE TO PATIENT CONDITION BECAUSE OF THEIR ABDOMINAL AORTIC ANEURYSM (AAA). THERE WERE NO INTRAPROCEDURAL ADVERSE EVENT OCCURRED AND NO INTRAPROCEDURAL DEVICE DEFICIENCIES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Cardiac Arrest

  MAUDE report 14254982 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 21MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH COMPLETE AV BLOCK POST IMPLANT PROCEDURE. ON AN UNKNOWN DATE A PACEMAKER WAS IMPLANTED. THE CAUSE OF THE AV BLOCK IS THOUGHT TO BE CAUSED BY DAMAGING THE HEART CONDUCTING SYSTEM DURING THE IMPLANTING PROCEDURE. THIS IS A COMMON ADVERSE EVENT RELATED TO AORTIC VALVE REPLACEMENTS (AVR) AND BENTALL PROCEDURES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT IS EXPECTED TO BE DISCHARGED. (B)(4).

  Patient problems: Heart Block

  MAUDE report 13004219 ↗
• DeathSep 18, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  (B)(6) 2019 JL: ADDITIONAL INFORMATION RECEIVED ON THIS DATE REPORTED THAT THE PATIENT HAD A RUPTURED AORTA AND CPR WAS IN PROGRESS WHEN BROUGHT INTO THE OR FOR THE VALVE IMPLANT PROCEDURE. (B)(6) 2019 JL: ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS BROUGHT TO THE OR IN GRAVE CONDITION; THE PATIENT HAD ALREADY RUPTURED AND CPR WAS IN PROGRESS WHEN THE PATIENT WAS BROUGHT TO THE OR FROM THE ICU. THE GRAFT WAS IMPLANTED, BUT THE PATIENT COULD NOT BE WEANED FROM BYPASS. INFORMATION RECEIVED FROM MEDICAL DEVICE REGISTRATION FORM NOTES THAT ON (B)(6) 2019, A 21MM MASTERS VALVE WAS IMPLANTED. ON THE SAME DAY, THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 9084078 ↗