SJM™ Masters Series HP Gelweave Valsalva 27VAVGJ-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05414734009515), received between Oct 14, 2021 and Aug 3, 2023 — classified as 17 injuries.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 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 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. THE GRAFT WAS SUCCESSFULLY PLACED WITHOUT DIFFICULTY. POST IMPLANT, THE MYOCARDIAL PACING LEADS WERE LEFT IN PLACE PER USUAL. ON (B)(6) 2023, ATRIAL FIBRILLATION WITH BRADYCARDIA AND ATRIOVENTRICULAR BLOCK WERE DETECTED VIA ELECTROCARDIOGRAM (ECG). AMIODARONE WAS ADMINISTERED AS TREATMENT. ANOTHER ECG WAS TAKEN ON (B)(6) 2023, AND IT WAS CONFIRMED THAT THE PATIENT WAS IN SINUS RHYTHM. ON (B)(6) 2023, THE MYOCARDIAL PACING LEADS WERE REMOVED. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED ON 17 JULY, WHICH SHOWED A SINGLE PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE WITH 17MM IN THE RIGHT ANTERIOR VENTRICLE, 17MM NEXT TO THE PULMONARY INFUNDIBULUM, AND 5-6MM IN THE RIGHT INFERIOR VENTRICLE. ANOTHER TTE WAS TAKEN ON (B)(6) 2023, AND THE PERICARDIAL EFFUSION WAS THE SAME SIZE (18MM MAXIMUM) AND WAS STABLE. NO INTERVENTION WAS PROVIDED TO TREAT THE PERICARDIAL EFFUSION. IT WAS STATED THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE REMOVAL OF THE MYOCARDIAL LEADS. THE PATIENT WAS DISCHARGED THE

  Patient problems: Atrial Fibrillation; Bradycardia; Heart Block

  MAUDE report 17455008 ↗
• 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: EU3549 - 353, (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED FOR A HISTORY OF PRIMARY VALVE DISEASE AND A 52MM ANEURYSM. A THORACIC AORTA REPAIR WAS ALSO PERFORMED DURING THE SAME SURGERY. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES RECORDED. ON (B)(6) 2023, THERE WAS SUSPICION OF AN INFECTED RETROSTERNAL HEMATOMA DUE TO ELEVATED WHITE BLOOD CELL (WBC) COUNT AND ELEVATED C-REACTIVE PROTEIN (CRP) TEST. THIS EVENT WAS REPORTED TO BE A PROCEDURAL COMPLICATION, AND THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE IMPLANTED DEVICE. THE PATIENT WAS ADMINISTERED ANTIBIOTIC CEFTRIAXONE. THE PATIENT'S HOSPITALIZATION WAS PROLONGED. ON (B)(6) 2023, THERE WAS PRONOUNCED SCARRING AND INFLAMMATORY SOFT TISSUE FORMATIONS IN THE LEFT GROIN WITH AIR INCLUSIONS, WHICH HAD A TOTAL DIAMETER OF 5CM, INDICATING AN ABSCESS. PATIENT WAS PRESCRIBED CLINDAMYCIN. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 16950313 ↗
• InjuryApr 7, 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 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED IN A PATIENT. ARRHYTHMIAS STARTED IN THE AFTERNOON POST IMPLANT, INITIALLY AS SUPRAVENTRICULAR EXTRA SYSTOLES, THEN BIGEMINIES, IN THE EVENING NUMEROUS MULTICENTRIC AGITATIONS. MEDICATION ADMINISTERED/ADJUSTED MAGNESIUM, POTASSIUM, CORDARONE, AND DIURETICS. THE PATIENT IS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 16702756 ↗
• InjuryMar 21, 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 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE VALVE WAS SIZED USING A ABBOTT/SJM MECHANICAL HEART VALVE SIZER SET. THE WERE INTRAPROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED DUE TO FLUID BEING DETECTED VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE) IN THE PATIENT'S PERICARDIAL SAC. THE SAME PERICARDIAL SAC FLUID WAS DETECTED ON TTE ON (B)(6) 2023 AND (B)(6) 2023. ON (B)(6) 2023, THE DECISION WAS MADE TO PERFORM A SURGICAL INTERVENTION FROM ACCESS UNDER THE XIPHOID PROCESS, THAT RESULTED IN 700 ML OF BLOOD BEING ASPIRATED FROM THE PATIENT'S PERICARDIAL SAC. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 16584854 ↗
• InjuryMar 21, 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 27MM 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 REPORTED. ON (B)(6) 2023, PRIOR TO DISCHARGE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH REVEALED THE PRESENCE OF FLUID/PERICARDIAL EFFUSION. ON (B)(6) 2023, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE OF THE PERICARDIAL SAC, AND ANOTHER THORACOTOMY WAS PERFORMED. AFTER THE INCISION, A LARGE AMOUNT OF PURULENT CONTENT WAS EVACUATED. IN THE PERICARDIAL SAC, THERE WERE CLOTS NOTED UNDER THE STERNUM. IN THE REGION OF THE LOWER AND LATERAL WALLS OF THE HEART, THERE WAS 1250ML OF DARK BLOOD. PATIENT DEVELOPED ANEMIA, THEREFORE ONE UNIT OF RED BLOOD CELLS WAS TRANSFUSED. THE TAMPONADE WAS DECOMPRESSED. PROLONGED HOSPITALIZATION WAS REPORTED DUE TO TREATMENT. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTIC THERAPY. THE CAUSE OF THE PURULENT CONTENT AND BLOOD CLOTS WAS BELIEVED TO BE THE RESULT OF THE CARDIAC TAMPONADE AND THE PRESENCE OF BLOOD IN THE PLEURAL CAVITIES. THE PER

  Patient problems: Anemia; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 16584304 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS (B)(6), (B)(6), (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM MASTERS MECHANICAL HEART VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2022, THE PATIENT HAD STERNAL DEHISCENCE POST-OPERATIVE WOUND INFECTION AND WAS TREATED WITH ANTIBIOTICS. ON (B)(6) 2022, SURGICAL INTERVENTION WAS PERFORMED. ON (B)(6) 2022, THE PATIENT DEVELOPED HEMOTHORAX ON BOTH SIDES. THEREFORE, ON (B)(6) 2022, THORACOCENTESIS WAS PERFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemothorax; Unspecified Infection

  MAUDE report 16555116 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM MASTER SERIES,VAVGJ WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION AND WAS TREATED WITH CARDIOVERSION. THE PATIENT IS STABLE, NO ADDITIONAL WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16536718 ↗
• InjuryMar 1, 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). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. PRIOR TO IMPLANT THE PATIENTS HEMOGLOBIN WAS 13.7 G/DL ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH ANEMIA. IT WAS NOTED THAT THIS WAS NOT DUE TO BLEEDING. A BLOOD TRANSFUSION WAS PERFORMED. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT IS REPORTED TO BE STABLE AND DISCHARGED.

  Patient problems: Anemia

  MAUDE report 16464008 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE PERICARDIAL EFFUSION RESULTING IN PERICARDIAL TAMPONADE. ON (B)(6) 2022, SURGICAL INTERVENTION WAS PERFORMED TO DECOMPRESS THE TAMPONADE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 15910410 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED THAT AT AN UNKNOWN POINT AFTER IMPLANT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION THAT WAS PRECEDED BY VENTRICULAR TACHYCARDIA. THE PATIENT WENT INTO CARDIAC ARREST AND HAD TO BE SHOCKED WITH 300 JOULES FOR DEFIBRILLATION. THE PATIENT WAS ADMINISTERED MAGNESIUM SULFATE, POTASSIUM CHLORIDE, LIGNOCAINE, AND GIVEN A CORDARON INFUSION. IT WAS NOTED THAT AFTER A FEW MINUTES THE PATIENT AGAIN EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT WAS AGAIN DEFIBRILLATED, BUT THIS TIME WITH ONLY 200 JOULES. THE PATIENT'S CORDARON INFUSION WAS INCREASED AND ADMINISTRATION OF LIGNOCAINE WAS CHANGED TO INTRAVENOUS. THE PATIENT'S CONDITION IMPROVED AFTER TREATMENT AND THERE WAS NO LONGER ANY VENTRICULAR FIBRILLATION DETECTED. THE EVENT RESULTED IN THE PATIENT BECOMING HOSPITALIZED TO MONITOR THEIR RHYTHM. THE PATIENT'S VENTRICULAR FIBRILLATION RESOLVED WITHOUT SEQUELAE. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 15897729 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT A 27MM MASTER SERIES,VAVGJ WAS IMPLANTED ON (B)(6) 2022. POST PROCEDURE ON (B)(6) 2022 THE PATIENT HAD A BILATERALLY PLURAL EFFUSION SHOWING ON CHEST X-RAY. FUROSEMIDE GIVEN WITH EFFECTIVENESS. ON (B)(6) 2022, IT WAS ALSO REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED ON TRANSTHORACIC ECHOCARDIOGRAM (TTE), HOWEVER NO TREATMENT WAS REQUIRED. PATIENT WAS SCHEDULED FOR REPEAT ECHO 2 WEEKS POST DISCHARGE DATE ((B)(6) 2022) AS OUTPATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 15269983 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT A 27MM MASTER SERIES, VAVGJ, WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WAS INTUBATED AND VENTILATED RESPIRATORY SEDATION GRADUALLY FLATTENED. RESPIRATORY MURMURS WERE HEARD SYMMETRICALLY; CIRCULATION WAS STABLE AND THE PATIENT WAS IN SINUS RHYTHM. AT APPROXIMATELY 10AM, COMPLETE HEART BLOCK WAS OBSERVED AND TREATED WITH A PACEMAKER AND EXTERNAL EPICARDIAL ELECTRODES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Adult Respiratory Distress Syndrome; Heart Block

  MAUDE report 15196203 ↗
• InjuryJul 27, 2022Adverse 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), R701614501. IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. NO INTRAPROCEDURAL ADVERSE EVENTS WERE NOTED. ON (B)(6) 2022, THE PATIENT HAD HIGH FREQUENCY ATRIAL FIBRILLATION ON ELECTROCARDIOGRAM (ECG). A CARDIOVERSION WAS PERFORMED ON (B)(6) 2022, AND THE PATIENT RETURNED TO SINUS RHYTHM. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 15117007 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. THERE WERE NO ADVERSE INTRAPROCEDURAL EVENTS REPORTED. ON (B)(6) 2022, THE PATIENT DEVELOPED POST-OPERATIVE BLEEDING DUE TO THE OPERATION. THE PATIENT WAS RETURNED TO SURGERY, AND IT WAS NOTED THAT THE BLEEDING WAS COMING FROM THE GRAFT ANASTOMOSIS. THE BLEEDING WAS STOPPED. THE PATIENT'S HEMOGLOBIN WAS 4.6 MMOL/L, AND THE PATIENT RECEIVED 3 UNITS OF RED BLOOD CELLS (RBC), 2 UNITS OF PLATELETS, AND 3 UNITS OF PLASMA. ON (B)(6) 2022, THE PATIENT DEVELOPED ATRIAL FIBRILLATION, WHICH WAS TREATED WITH AMIODARONE. THE ATRIAL FIBRILLATION RESOLVED ON (B)(6) 2022. ON (B)(6) 2022, HEMOGLOBIN WAS 5.0 MMOL/L, AND THE PATIENT RECEIVED ONE UNIT OF RBC. ON (B)(6) 2022, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO HYPERVOLEMIA, WHICH WAS TREATED WITH DIURETICS AND WAS RESOLVED BY (B)(6) 2022.

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14595122 ↗
• InjuryMay 13, 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 SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND AORTIC DISSECTION. DEFIBRILLATION WAS PERFORMED TWICE, AND THE PATIENT HEART RETURNED TO SINUS RHYTHM. NO DEVICE DEFICIENCIES WERE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 14392993 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING POST OPERATIVE ANEMIA AND THE PATIENT WAS TRANSFUSED WITH RED BLOOD CELLS. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. (B)(4).

  Patient problems: Anemia

  MAUDE report 12851500 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, 27MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED WITHOUT ANY COMPLICATIONS. POST PROCEDURE AND DURING REPERFUSION VENTRICULAR TACHYCARDIA WAS NOTED. A CARDIOVERSION WAS PERFORMED AND PATIENT RETURNED TO REGULAR RHYTHM. ON (B)(6) 2021, ATRIAL FIBRILLATION (AF) WAS REPORTED AND PATIENT WAS CARDIOVERTED. ON (B)(6) 2021, AF CAME BACK AND PATIENT WAS CARDIOVERTED AGAIN. IT WAS NOTED THAT THERE WAS NO RELATIONSHIP WITH THE AORTIC VALVED GRAFT AND THE ARRHYTHMIA IS A KNOWN RISK. THE PATIENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. (CRD_992 - VALVED GRAFTS PAS; (B)(4).

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 12637376 ↗