SJM™ Masters Series HP Gelweave Valsalva 25VAVGJ-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05414734009492), received between Sep 23, 2020 and Nov 30, 2023 — classified as 2 deaths, 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS. US0285 - 458 (R802140901). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM MASTERS VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD A PULMONARY EFFUSION, THAT WAS NOT HEMORRHAGIC IN NATURE AND A THORACENTESIS WAS PERFORMED. THE PATIENT IS STABLE.

  Patient problems: Pulmonary Edema

  MAUDE report 18241259 ↗
• MalfunctionNov 16, 2023

  VALVE STICKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147748 ↗
• InjuryMay 10, 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 - 354 (R750360501, R751468701, R753412001) IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. A MAZE PROCEDURE AND A LEFT ATRIAL APPENDAGE CLOSURE WERE ALSO PERFORMED DURING THE SAME SURGERY. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES RECORDED. ON (B)(6) 2023, THE PATIENT EXPERIENCED NEWLY ONSET ACUTE KIDNEY INJURY/RENAL FAILURE. A PRERENAL OR INFLAMMATORY CAUSE AFTER POST-OPERATIVE VOLUME FLUCTUATIONS OR TEMPORARILY REDUCED PERFUSION WAS MOST LIKELY PER PHYSICIAN. PATIENT HAD ELEVATED CREATININE, AND HOSPITALIZATION WAS PROLONGED. ON (B)(6) 2023, AN X-RAY AND TRANSTHORACIC ECHOCARDIOGRAM REVEALED THAT PATIENT HAD LEFT PLEURAL EFFUSION WITH ATELECTASIS AND LESS PRONOUNCED RIGHT PLEURAL EFFUSION. PATIENT ALSO HAD DYSPNEA, PARTIAL RESPIRATORY INSUFFICIENCY, AND HIGH OXYGEN DEMAND. A PLEURAL DRAIN WAS INSERTED ON THE LEFT SIDE, AND APPROXIMATELY 1000ML OF OLD BLOOD-SEROUS SECRETION WAS DRAINED. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AND A PSEUDOANEURYSM WAS DETECTED IN THE LEFT GROIN ON ULTRASOUND. ON (B)(6) 2023, THE PATIE

  Patient problems: Dyspnea; Pain; Pleural Effusion; Pseudoaneurysm; Renal Failure; Respiratory Insufficiency

  MAUDE report 16903754 ↗
• InjuryApr 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), (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 25 MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. ON THE SAME DAY, THE PATIENT HAD BLEEDING THAT REQUIRED A RED BLOOD CELL, PLATELET, AND PLASMA TRANSFUSION. THE PHYSICIAN NOTED THAT EVERY SINGLE NEEDLE HOLE WAS BLEEDING DESPITE THE PROTAMINE ADMINISTRATION. THEREFORE, PRE-EMPTIVE MODIFIED CABROL PATCH WAS CREATED USING BOVINE PERICARDIUM. THE PATCH WAS SUTURED ALONG THE MEDIAL ASPECT OF THE PA, DISTAL ASCENDING AORTA, SVC, UPPER ASPECT OF THE RIGHT ATRIA AND RIGHT VENTRICLE USING RUNNING 4-0 STITCH. ONCE THIS PATCHING WAS COMPLETED, NO MORE SIGNIFICANT BLEEDING WAS SEEN. THE PATIENT ALSO HAD DECREASED URINARY OUTPUT REQUIRING LACTATE RINGERS ON (B)(6)2023 AND (B)(6) 2023. ON (B)(6) 2023, AN X-RAY WAS PERFORMED AND SHOWED THAT THE PATIENT WAS HAVING A LEFT PLEURAL EFFUSION. THE PATIENT ALSO HAD HYPOVOLEMIA WHICH REQUIRED A PACKED RED BLOOD CELL TRANSFUSION. ON (B)(6) 2023, THE PATIENT HAD ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND WAS TREATED WITH AMIODARONE AND METOPROL

  Patient problems: Atrial Fibrillation; Dyspnea; Electrolyte Imbalance; Hemorrhage/Blood Loss/Bleeding; Pain; Pleural Effusion; Tachycardia

  MAUDE report 16668744 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - VALVED GRAFTS PAS. (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023 A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SELECTED FOR AN IMPLANT. POST-PROCEDURE, CHEST X-RAY SHOWED NO VASCULAR PATTERN IN THE PERIPHERAL PART OF THE LUNG, NO CLEAR VASCULAR PATTERN IN THE APEX OF THE LUNG, SUPRAPAPHRAGMATIC RADIOLUCENCY, ELECTRICAL RADIOLUCENCY BAND AT THE RIGHT SILHOUETTE OF THE HEART, THE RIGHT LUNG FIELD WITH INCREASED TRANSPARENCY IN RELATION TO THE LEFT - THE IMAGE MAY SUGGEST THE PRESENCE OF A PNEUMOTHORAX RIGHT-SIDED PLEURA. ON (B)(6) 2023, ON CHEST X-RAY, THERE WAS A RIGHT MANTLE PNEUMOTHORAX 26MM AT THE TOP 11MM ALONG THE CHEST WALL. A SURGICAL INTERVENTION WAS DONE TO TREAT THE PNEUMOTHORAX AND THE DEVICE IS WORKING AS INTENDED. PATIENT STABLE.

  Patient problems: Pneumothorax

  MAUDE report 16657158 ↗
• InjuryMar 27, 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 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. AFTER THE PROCEDURE, THE PATIENT HAD INCREASED DRAINAGE, CLOTS, AND A HEMATOMA. A THORACOTOMY WAS PERFORMED AND THE TAMPONADE DECOMPRESSED. IN ADDITION, THE PATIENT WAS TRANSFUSED PLASMA. THE PATIENT HAD VENTRICULAR FIBRILLATION. DEFIBRILLATION WAS ADMINISTERED TWICE. ON (B)(6) 2023, SEIZURE WAS OBSERVED WITH THE FOLLOWING SYMPTOMS: TREMOR OF THE LEFT LIMBS, NYSTAGMUS, THE LEFT LOWER LIMB AND UPPER LIMBS MOVED SPONTANEOUSLY, THE RIGHT LIMBS DID NOT MOVE. THE PATIENT WAS DIAGNOSED WITH CYTOTOXIC EDEMA IN THE COURSE OF ISCHEMIC CHANGES IN THE ACUTE PHASE. MEDICATION WAS ADMINISTERED AND THE PATIENT WAS TRANSFUSED RED BLOOD CELLS. IT WAS NOTED THAT THE PATIENT HAD LOW LEVELS OF FIBRINOGEN. THE DEVICE REMAINED IMPLANTED AND WAS REPORTEDLY WORKING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2023, THE PATIENT WAS TRANSFUSED WITH RED BLOOD CELLS. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT FLUID PRES

  Patient problems: Cardiac Tamponade; Convulsion/Seizure; Hematoma; Pericardial Effusion; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 16619367 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH HEART RATE OF 130BEAT/MIN AND WAS TREATED WITH CORDARONE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Atrial Fibrillation

  MAUDE report 16611591 ↗
• InjuryMar 23, 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 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN AORTIC TICK REQUIRING HEMOSTASIS CONTROL VIA REPERFUSION. THE PATIENT ALSO WENT INTO VENTRICULAR FIBRILLATION AND REQUIRED DEFIBRILLATION. NO CONCOMITANT CARDIAC PROCEDURES WERE PERFORMED. THERE WERE NO INTRAPROCEDURAL DEVICE DEFICIENCIES NOTED. POST PROCEDURE ON (B)(6) 2023, THE PATIENT HAD INCREASED POST-OPERATIVE BLEEDING AND REQUIRED A RE-THORACOTOMY AND MEDIASTINAL REVISION. BLOOD CLOTS WERE REMOVED, RESIDUAL BLOOD WAS OBSERVED IN THE PERICARDIAL SAC, THE LEFT PLEURAL CAVITY WAS ASPIRATED, AND THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND PLASMA. TWO BLEEDING SITES WERE FOUND AND TREATED. PATIENT HAD ANEMIA IN THE FORM OF DECREASED HEMOGLOBIN AND HEMATOCRIT DUE TO BLEEDING. FURTHER BLOOD TRANSFUSIONS WERE GIVEN ON (B)(6), (B)(6), AND (B)(6) 2023. THESE EVENTS WERE LIFE-THREATENING AND REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 16606319 ↗
• 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 25MM 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 REPORTED. ON (B)(6) 2023, THE PATIENT HAD A LOW GFR (GLOMERULAR FILTRATION RATE) AT 37 ML/MIN/1.73M^2. THE PATIENT'S BLOOD UREA NITROGEN (BUN) WAS ELEVATED AT 10.4 MMOL/L. THE PATIENT'S CREATININE WAS ALSO ELEVATED. THE PATIENT HAD AN ACUTE KIDNEY INJURY. ON (B)(6) 2023, PATIENT WAS ADMINISTERED FUROSEMIDE AND FLUIDS FOR DIURESIS SUPPORT. THE PATIENT HOSPITALIZATION WAS PROLONGED DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF MALFUNCTION MADE AGAINST THE ABBOTT DEVICE. THE EVENT WAS BELIEVED TO BE RELATED TO THE INDEX PROCEDURE, AND THERE WAS NO KNOWN PATIENT HISTORY OF KIDNEY DISEASE PRIOR TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Renal Failure

  MAUDE report 16584284 ↗
• InjuryMar 17, 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) 2022, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO THE PATIENT. ON (B)(6) 2022, THE PATIENT HAD A C-REACTIVE PROTEIN AND LEUKOCYTOSIS ELEVATION. IT IS BELIEVED THE PATIENT HAD AN INFECTION. MEDICATION WAS ADMINISTERED. THE PATIENT IS REPORTED TO BE RECOVERED. THE PATIENT HAD PROLONGED HOSPITALIZATION DUE TO THIS EVENT. NO PATIENT SYMPTOMS, NO HEALTH CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 16564290 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS. PAS SP1638 - 955 (R739988101). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM MASTER SERIES,VAVGJ WAS SUCCESSFULLY IMPLANTED. POST PROCEDURE, BUT PRIOR TO DISCHARGE FROM HOSPITAL ON (B)(6) 2023, ELECTROCARDIOGRAM SHOWED THAT THE PATIENT HAD ATRIAL FIBRILLATION AND WAS TREATED WITH BETABLOCKER. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16537202 ↗
• InjuryMar 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), (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2023, IT WAS NOTED VIA ELECTROCARDIOGRAM, THAT THE PATIENT DEVELOPED A THIRD DEGREE HEART BLOCK. ON (B)(6) 2023, THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER TO TREAT THE HEART BLOCK. THE EVENT RESULTED IN PROLONGED HOSPITALIZATION OF THE PATIENT. THE CAUSE OF THE PATIENT DEVELOPING A THIRD DEGREE HEART BLOCK IS CURRENTLY UNKNOWN. NO PATIENT CONSEQUENCES WERE REPORTED. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS A HISTORY OF ATRIAL FIBRILLATION WITH LEFT ANTERIOR FASCICULAR BLOCK. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. THE 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SIZED USING AN UNKNOWN VALVE PROBE. THERE WAS NO DIFFICULTY EXPERIENCED DURING IMPLANT AND THE FINAL IMPLANT DEPTH WAS SUPRA-ANULAR. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE

  Patient problems: Heart Block

  MAUDE report 16493238 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. AFTER THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH COAGULOPATHY DUE TO EXTENDED TIME ON BYPASS. A BLOOD, PLATELET, AND CRYOPRECIPITATE TRANSFUSION WAS ADMINISTERED WITH THE PATIENT RETURNING TO GOOD HEMOSTASIS. IT IS SUSPECTED THAT THE COAGULOPATHY WAS DUE TO THE IMPLANT PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16478204 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS, PL5012 - 193 (R733453901, R733449301). IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SELECTED FOR AN IMPLANT DUE TO THE PATIENT HAVING MULTIPLE VENTRICULAR FIBRILLATION DEFIBRILLATIONS. BASED ON THE IMAGE OF THE HEART AND ELECTRICAL ACTIVITY, A CORONARY ARTERY BYPASS SURGERY (CABG) WAS PERFORMED. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT BEGAN SHOWING STROKE SYMPTOMS. ON (B)(6) 2022, THE PATIENTS LEFT UPPER LIMB WAS WEAKER, PARESIS-HEAD COMPUTER TOMOGRAPHY WAS PERFORMED. IN THE AREA OF THE POSTERIOR BRANCH OF THE RIGHT INTERNAL CAPSULE AND THE RIGHT THALAMUS, A HYPOECHOIC AREA WITH DISCRETE MODELING OF THE THIRD VENTRICLE - ISCHEMIC CHANGE IN THE ACUTE PHASE OF STROKE WAS OBSERVED. THE PATIENT WAS TREATED WITH AMANTADYNA INTRAVENOUSLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Stroke/CVA; Ventricular Fibrillation

  MAUDE report 16342213 ↗
• InjuryFeb 1, 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: US0172-855, R731666301, R731672401, R731803601. IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH A HISTORY OF KIDNEY DISEASE AND A KIDNEY TRANSPLANT. ON (B)(6) 2022, THE PATIENT WAS NOTED TO BE SUFFERING FROM WORSENING KIDNEY DISEASE, THE PATIENT'S BASELINE CREATINE LEVELS WERE AS FOLLOWS, ON (B)(6) 2022: 2.33 MG/DL AND PROGRESSED TO 2.98 MG/DL, AND ON (B)(6) 2023 = 2.93 MG/DL. THIS EVENT RESULTED IN HOSPITALIZATION OF THE PATIENT. ON (B)(6) 2022, THE PATIENT DEVELOPED STERNAL CHEST PAIN AND AN ONSET OF HEMOPTYSIS. THE PATIENT WAS SUFFERING FROM TACHYPNEA, THE PATIENT BECAME INCREASINGLY IN NEED OF OXYGEN. THE PATIENT HAD FILLED A BASIN WITH 100ML OF A MIX OF BLOOD AND SPUTUM. THE PATIENT'S HEPARIN INFUSION WAS THEN WITHHELD. A CHEST X-RAY REVEALED BILATERAL INFILTRATES. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. A LARYNGOSCOPY WAS PERFORMED AND FOUND NO ACTIVE BLEEDING OF THE UPPER AIRWAY. ON (B)(6) 2022, THE PATIENT WAS NOTED THE HAVE AN ALTERED MENTAL STATUS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND DISCOVERE

  Patient problems: Angina; Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage

  MAUDE report 16277601 ↗
• DeathJan 30, 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 STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM MASTERS SERIES MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. HEPARIN WAS ADMINISTERED WITH AN ACTIVATED CLOTTING TIME (ACT) OF 433 SECONDS. ON (B)(6) 2022, THE PATIENT HAD A SURGICAL INTERVENTION DUE TO SMALL AMOUNTS OF CLOTS UNDER THE STERNUM AND IN THE AREA OF THE RIGHT ATRIUM. THE CLOTS WERE REMOVED, AND NO BLEEDING SPOTS NOTED. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) CLOSEST TO THE TIME OF THE REPORTED THROMBUS MEASURED ON (B)(6) 2022 WAS 1.93 AND THE LAST INR MEASURED WAS 1.66. NO HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY MENTIONED IN THE MEDICAL HISTORY OF THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16269108 ↗
• InjuryJan 6, 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 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT EXPERIENCED DETERIORATION OF WELL-BEING, MALAISE, AND TACHYCARDIA. A CHEST X-RAY AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE DONE, SHOWING FEATURES OF A HEMATOMA IN THE MEDIASTINUM BETWEEN THE LEFT AND RIGHT CORONARY ARTERY. A RESTERNOTOMY WAS PERFORMED DUE TO TAMPONADE, AND A BLOOD TRANSFUSION WAS GIVEN. WARFARIN WAS PRESCRIBED. PERICARDIAL TAMPONADE DECLARED RESOLVED. IT IS BELIEVED THAT THE PERICARDIAL EFFUSION IS NOT RELATED TO THE DEVICE. THE PATIENT IS REPORTED TO BE DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Hematoma; Pleural Effusion; Tachycardia

  MAUDE report 16117579 ↗
• InjuryDec 1, 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 25MM MASTERS VALVE WAS SELECTED FOR AN IMPLANT. INTRA-OPERATIVE BLEEDING WAS NOTED DUE TO COMPLEX SURGICAL REPAIR. POST-IMPLANT, THE PATIENT WAS TRANSFUSED 2 UNITS PACK RED BLOOD CELLS (PRBC), 6 UNITS PLATELETS AND 6 UNITS PLASMA. HEPARIN WAS ADMINISTERED WITH THE FOLLOWING ACTIVATED CLOTTING TIME (ACT) LEVELS ACT'S: AT 19:45 112 SECONDS , AT 21:15 467 SECONDS , AT 21:30 487 SECONDS , AT 21:45 720 SECONDS , AT 22:15 632 SECONDS, AT 22:45 536 SECONDS, AT 23:45 123 SECONDS. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS PRE-OP ON (B)(6) 1.1, POST-OP ON (B)(6) 1.2, AT DISCHARGE ON (B)(6) 2.5, CURRENT ON (B)(6) 2.7. THE ISSUE WAS REPORTED TO BE RESOLVED WITH SEQUELAE OF BLOOD LOSS ANEMIA WITH NO FURTHER TREATMENT PLANNED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15895245 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) VALVED GRAFTS PAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2022, ATRIAL FIBRILLATION OCCURRED ON ELECTROCARDIOGRAM (EKG). ONE DOSE OF INTRAVENOUS (IV) AMIODARONE WAS ADMINISTERED, AND PATIENT RETURNED TO NORMAL SINUS RHYTHM. IT WAS NOTED THAT NO CONCOMITANT PROCEDURE WAS PERFORMED AND NO INTRAPROCEDURAL ADVERSE EVENTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 14997525 ↗
• DeathMay 13, 2022Incomplete Coaptation; Insufficient Device Problem Information; Physical Resistance/Sticking; Incomplete Coaptation; Insufficient Device Problem Information; Physical Resistance/Sticking

  THIS EVENT IS BEING CONSERVATIVELY REPORTED DUE TO A PATIENT IMPLANTED WITH AN UNKNOWN ABBOTT VALVE WHO PASSED AWAY SHORTLY AFTER PROCEDURE, THE CAUSE OF DEATH REMAINS UNKNOWN. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN ABBOTT HEART VALVE WAS IMPLANTED. IN (B)(6) 2022, A PHONE CALL WAS RECEIVED FROM THE PATIENT'S SPOUSE INDICATING THAT THE PATIENT HAD PASSED AWAY SHORTLY AFTER THE PROCEDURE BECAUSE THE IMPLANTED HEART VALVE HAD FAILED. IT WAS INDICATED THAT THIS EVENT OCCURRED ALMOST 12 MONTHS PRIOR. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest; Insufficient Information

  MAUDE report 14392264 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT TESTED POSITIVE FOR COVID-19. ON (B)(6) 021, THE PATIENT PRESENTED WITH A WOUND INFECTION WAS NOTED AND SURGICAL INTERVENTION TOOK PLACE. IT IS THOUGHT THAT THE INFECTION WAS DUE TO LACK OF HYGIENE AND FAILURE TO FOLLOW THE RECOMMENDATIONS POST PROCEDURE. A ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED THAT THE SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS PERFORMING AS INTENDED. THE PATIENT SINCE HAS BEEN DISCHARGED AND WAS REPORTED TO BE IN STABLE CONDITION. (CRD_992 - VALVED GRAFTS PAS; PL5215-107; R640196801, R640198101).

  Patient problems: Skin Infection

  MAUDE report 12908250 ↗
• InjuryJan 14, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2021, VALVULAR LEAK WAS CONFIRMED POST IMPLANT FROM THE JUNCTION OF THE MECHANICAL HEART VALVE TO VALSALVA GRAFT AFTER LEAVING PROCEDURE ROOM. THE SURGEON HAD TO TAKE THE PATIENT BACK TO THE OPERATING ROOM AND REPAIR THE LEAK AREA WITH PROLINE SUTURE SIZE 4/0.

  Patient problems: Insufficiency, Valvular

  MAUDE report 11174982 ↗
• MalfunctionSep 23, 2020Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  ON (B)(6) 2020, A 25MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT IN THE PATIENT. DURING THE AORTIC ROOT REPLACEMENT PROCEDURE, THE PHYSICIAN USED THE VALVE ROTATOR RECOMMENDED IN THE IFU, BUT ONE OF THE LEAFLETS WAS DAMAGED BY ROTATING THE DISCS. ONE OF THE LEAFLETS DISCONNECTED FROM THE HINGE, THE VALVE WAS REMOVED FROM THE PATIENT, AND A CARBOMEDICS VALVE WAS IMPLANTED INSTEAD. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, BUT THE PROCEDURE WAS EXTENDED BY 30-45 MINUTES. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574969 ↗