SJM™ Masters Series HP Gelweave Valsalva 29VAVGJ-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734009508), received between Mar 13, 2020 and Jan 10, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. POST OPERATION THE PATIENT DEVELOPED CARDIOGENIC/HYPOVOLEMIC SHOCK. THE PATIENT RECEIVED A SHORT INFUSION OF NICARDIDINE AND LACTATED RINGERS SOLUTION WITH RESOLUTION OF THE SHOCK. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16130861 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(4) - VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED TEMPORARY AMAUROSIS FUGAX IN THEIR RIGHT EYE FOR ONE MINUTE. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND FOUND NO INTRACRANIAL HEMORRHAGE, INFARCT, HYDROCEPHALUS, AND NO SIGNS OF HERNIATION. AN ANGIOGRAM WAS PERFORMED AND FOUND REGULAR CONTRAST OF THE PATIENT'S CERVICAL AND INTRACRANIAL VESSELS. AN ULTRASOUND WAS ALSO PERFORMED AND FOUND NORMAL FINDINGS OF EXTRACRANIAL AND TRANSCRANIAL BLOOD SUPPLYING ARTERIES. IT WAS ALSO DISCOVERED THAT THE PATIENT TESTED POSITIVE FOR COVID-19. THERE WAS NO TREATMENT PERFORMED/REQUIRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2022, BUT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DUE TO POSSIBLE THROMBUS THAT HAD ADHERED TO THE 29MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED DEPOSITS ADHERED TO THE 29MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT IMPLANTED IN THE PATIENT. ON (B)(6) 2022, CARDIAC CATHERIZATION WAS PERFORMED AND FOU

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16127874 ↗
• InjurySep 23, 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 ON (B)(6) 2022, A 29MM MASTER SERIES,VAVGJ WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO INCREASED DYSPNEA AND EDEMA. PATIENT WAS TREATED WITH DIURETICS AND IS IN STABLE CONDITION. THE DEVICE WAS REPORTED TO BE WORKING AS INTENDED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 15474394 ↗
• InjurySep 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 29 MM MASTERS VALVE WAS IMPLANTED. ON (B)(6) 2022, PAROXYSMAL ATRIAL FIBRILLATION WAS OBSERVED AND TREATED WITH AMIODARONE AND HOME MEDICATION (VERAPAMIL, METOPROLOL, POTASSIUM) WAS ADJUSTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Atrial Fibrillation

  MAUDE report 15414364 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 29MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT HAD POST-OP RESPIRATORY FAILURE AND WAS CONTINUED ON FULL VENT SUPPORT. ON (B)(6) 2022, THE PATIENT EXTUBATED. ON (B)(6) 2022, THE PATIENT WAS REINTUBATED DUE TO HYPOXIA AND ON (B)(6) 2022, IT WAS ATTEMPTED TO WEAN THE PATIENT OFF OF OXYGEN (O2) AND CONDUCTION DISTURBANCES WERE NOTED ON AN ELECTROCARDIOGRAM (ECG). THE PATIENT REMAINED ON AC WITH SEDATION AND IV NOREPINEPHRINE. ON (B)(6) 2022, THE PATIENT EXTUBATED AGAIN. ON (B)(6) 2022, AN ECHOCARDIOGRAM WAS PERFORMED AND A PERICARDIAL TAMPONADE WAS NOTED. NO INTERVENTION WAS FOR THE ARRHYTHMIA. A SUBXIPHOID PERICARDIAL WINDOW WAS PERFORMED AND THE PATIENT RE INTUBATED AGAIN. ON (B)(6) 2022, THE PATIENT RECEIVED A TRACHEOSTOMY. THE PATIENT REMAINS IN THE HOSPITAL AND IS NOT DOING WELL. ((B)(4) - VALVED GRAFTS PAS; (B)(4)).

  Patient problems: Anemia; Arrhythmia; Cardiac Tamponade; Hypoxia; Respiratory Failure

  MAUDE report 13607419 ↗
• InjuryDec 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29 MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE VALVE WAS SUCCESSFULLY IMPLANTED, BUT WHILE CHECKING THE LEAFLETS WITH THE LEAFLET TESTER, THE PHYSICIAN WAS CONCERNED WITH THEIR MOVEMENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT VALVE AND A VALSALVA GRAFT TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, BUT DUE TO THE FRAILTY OF THE PATIENT, THE PROLONGED PROCEDURE WAS CLINICALLY SIGNIFICANT. THE PATIENT IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914437 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  ON (B)(6) 2019 A LEAFLET OF A MASTERS MECHANICAL VALVE DISLODGED DURING EXPLANT. LEAFLET WAS RETRIEVED BY DOCTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829696 ↗