SJM™ Masters Series HP Gelweave Valsalva 23VAVGJ-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734009522), received between Jan 6, 2020 and Jul 26, 2024 — classified as 3 deaths, 17 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; 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 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2024, THE PATIENT WAS ADMITTED AT THE EMERGENCY ROOM WITH COMPLAINT OF CHEST PAIN OF THE COURSE OF 7 DAYS. THE PATIENT'S CHEST PAIN WAS NOTED TO HAVE WORSENED IN THE LAST TWO DAYS. A CHEST COMPUTED TOMOGRAPHY ANGIOGRAM WAS PERFORMED AND REVEALED A PSEUDOANEURYSM. AN UNKNOWN TREATMENT WAS PERFORMED.

  Patient problems: Angina; Endocarditis; Fatigue; Pain; Pseudoaneurysm

  MAUDE report 19842154 ↗
• DeathAug 23, 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) 2022, 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO INTRAPROCEDURAL DEVICE DEFICIENCIES OR ADVERSE EVENTS REPORTED. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH AN ACUTE KIDNEY INJURY AND HAD ANURIA, WHICH WAS CAUSED BY POST-OPERATIVE ACUTE RENAL FAILURE (UNSPECIFIED). THE PATIENT HAD MULTIPLE CYCLES OF CONTINUOUS RENAL REPLACEMENT THERAPY AND HAD A HISTORY OF KIDNEY DISEASE. PATIENT WAS UNRESPONSIVE TO THE MEDICATION FUROSEMIDE WITH THEOPHYLLINE. ON (B)(6) 2022, THE PATIENT HAD NUMEROUS PETECHIAE ON THE SKIN OF THE RIGHT FOOT, AND MARBLED SKIN ON THE LEFT THIGH, WHICH WAS BELIEVED TO BE RELATED TO THE PROCEDURE. PATIENT HAD NECROSIS OF BOTH FEET AFTER INTRAVASCULAR COAGULATION. ON (B)(6) 2022, THE PATIENT HAD SYMPTOMS OF A BRAINSTEM INJURY AND WAS UNABLE TO MAKE ACTIVE MOVEMENTS IN 4 LIMBS. THE BRAINSTEM DISORDER WAS BELIEVED TO BE RELATED TO THE PROCEDURE. ON (B)(6) 2022, THE COMPUTED TOMOGRAPHY (CT) SCAN OF HEAD SHOWED CORTICAL AND SUBCORTICAL ATROPHY OF THE BRAIN AND CEREBELLUM. ON (B)(6) 2022, THE PATIENT PASSED AWAY DUE T

  Patient problems: Brain Injury; Heart Failure/Congestive Heart Failure; Renal Failure; Respiratory Insufficiency; Unspecified Tissue Injury

  MAUDE report 17606777 ↗
• InjuryJul 26, 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) 2023 A 23MM MASTER SERIES, VAVGJ WAS IMPLANTED IN A PATIENT. THE PATIENT ALSO PRESENTED ANEMIA AND WAS TREATED WITH ONE UNIT OF BLOOD TRANSFUSION. PRIOR TO THE IMPLANT PROCEDURE, THE PATIENT HEMOGLOBIN WAS 15.5G/DL. THE PHYSICIAN REPORTED THAT THE ANEMIA WAS PROCEDURE RELATED. IT WAS ALSO REPORTED THAT ON 17 MARCH 2023, THE PATIENT PRESENTED WITH PNEUMONIA FEATURES AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT IS STABLE.

  Patient problems: Anemia; Pneumonia

  MAUDE report 17400436 ↗
• InjuryMay 17, 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 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS CHOSEN FOR IMPLANT. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.00 AT BASELINE. THE GRAFT WAS NOT PRE-CLOTTED. THE PATIENT WAS GIVEN 4500 IE OF HEPARIN IN PRE-OP, AND 115000 IE DURING THE PROCEDURE. THE DEVICE WAS SUCCESSFULLY IMPLANTED. AFTER THE DEVICE WAS IMPLANTED AND PATIENT WAS BEING WEANED OFF BYPASS, BLEEDING WAS OBSERVED DORSAL TO THE RIGHT CORONARY ARTERY (RCA) ON THE RCA ANASTOMOSIS. DIRECTLY POST PROCEDURE, THE PATIENT'S INR WAS 1.22 AND THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS 412 SECONDS. A RIGHT CORONARY ARTERY RE-INSERTION SURGERY WAS EMERGENTLY PERFORMED TO TREAT THE BLEED. A TOTAL OF THREE UNITS (1807ML) OF BLOOD AND/OR BLOOD PRODUCTS WERE ADMINISTERED DUE TO THIS EVENT. ON (B)(6) 2023, THE PATIENT WENT INTO ATRIAL FIBRILLATION. PATIENT WAS ADMINISTERED AMIODARONE AND HAD CARDIOVERSION. THE PATIENT CONTINUED TO BE FOLLOWED IN THE CLINICAL STUDY.

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

  MAUDE report 16950553 ↗
• InjuryApr 27, 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: PL5012 - 199 (R749173601, R754286001) SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT THE PATIENT HAD A LOW HEMOGLOBIN OF 7.6 G/DL ON (B)(6)2023. THE PATIENT'S HEMOGLOBIN IMPROVED ON 12 MARCH 2023 TO 9.6G/DL AND INCREASED TO 10.3 G/DL ON 16 MARCH 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Anemia; Pericardial Effusion; Unspecified Infection

  MAUDE report 16825689 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, ELECTROCARDIOGRAM SHOWED COMPLETE BLOCK; HEART RHYTHM WAS CONTROLLED BY AN EXTERNAL PACEMAKER. ON THE SAME DAY, ELECTROCARDIOGRAM IN THE EVENING SHOWED A 3RD DEGREE ATRIAL VENTRICLE BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 16735143 ↗
• 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: PL5215 - 136 (R744149201) IT WAS REPORTED THAT ON (*B)(6) 2023, A 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED. ON THE SAME DAY POST PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARREST IN THE FORM OF PULSELESS ELECTRICAL ACTIVITY (PEA). A CORONARY ANGIOGRAM WAS PERFORMED AND SHOWED RIGHT CORONARY ARTERY OCCLUSION CAUSED BY CLOTS. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED, AND A STENT WAS PLACED TO OPEN THE BLOCKED RIGHT CORONARY ARTERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Cardiac Arrest; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 16704901 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS SP1638-956 R742760001. IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, 24 HOURS POST PROCEDURE AND AFTER EXTUBATION, THE PATIENT WAS STABLE THE FIRST FEW HOURS. LATER THAT DAY, THE PATIENT DEVELOPED MILD DYSARTHRIA AND MILD HEMIPARESIS OF THE RIGHT UPPER LIMB THAT LED TO A NEUROLOGICAL STUDY FOR SUSPECTED ISCHEMIC STROKE, WHICH WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT) PERFUSION. THE PATIENT WAS TREATED WITH ACENOCUMAROL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Stroke/CVA

  MAUDE report 16611615 ↗
• InjuryMar 21, 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 23 MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, BRADYCARDIA WAS OBSERVED AND MEDICATION WAS ADMINISTERED. THE BRADYCARDIA WAS NOT RELATED OR WORSENED DUE TO THE DEVICE, BUT WAS DUE TO THE PROCEDURE. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia

  MAUDE report 16584652 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS. PL5215 - 131 (R740569201). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM MASTER SERIES,VAVGJ WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE PATIENT HAD INCREASE OF LEUKOCYTOSIS AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT IS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16575394 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS. PL5215 - 127 (R740299301, R740305701). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM MASTERS MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED HIGH AMOUNT OF FLUID IN PERICARDIUM AROUND THE WHOLE HEART. HEMATOMA BEHIND THE RIGHT VENTRICLE WHICH WAS PERICARDIAL TAMPONADE AND TREATED WITH TAMPONADE DECOMPRESSION WITH SURGICAL INTERVENTION. AFTER THE PERICARDIAL TAMPONADE WAS DRAINED PATIENT RECEIVED HEPARIN UNTIL DISCHARGE ON (B)(6) 2022, THE PATIENT HAD C-REACTIVE PROTEIN AND LEUKOCYTOSIS ELEVATION. ANTIBIOTICS WERE ADMINISTERED/ADJUSTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Cardiac Tamponade

  MAUDE report 16558621 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6) ((B)(6),(B)(6)). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. THE PATIENT HAD A HIGH AMOUNT OF BLOOD DRAINAGE POST OPERATIVELY FOR 30 MINUTES. SURGICAL INTERVENTION WAS PERFORMED AND 3 UNITS OF BLOOD AND BLOOD PRODUCTS GIVEN. ON (B)(6) 2023, THE PATIENT HAVE ELEVATED C-REACTIVE PROTEIN AND LEUKOCYTOSIS. AN UNSPECIFIED INFECTION IS SUSPECTED AND MEDICATION WAS ADMINISTERED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 16554317 ↗
• InjuryMar 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CRD_992 - VALVED GRAFTS PAS PL5012-195 R739423601 IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM MASTERS MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. WHILE TRANSPORTING THE PATIENT TO THE OPERATING ROOM TO CONNECT THE PATIENT TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), A PULMONARY EDEMA WAS NOTED BEFORE CONNECTING. ON (B)(6) 2023, AFTER EVALUATION OF LABORATORY TESTS, GASOMETRY, CHEST X-RAY, AND LEFT PLEURAL PUNCTURE WITH EVACUATION OF 200ML OF BLOOD FLUID, THE ECMO CANNULAS WERE REMOVED. DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, CHEST COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WHICH SHOWED FLUID AND CLOTS IN THE LEFT PLEURAL CAVITY. THORACOTOMY WAS PERFORMED AND 1700 ML OF CLOTS AND FLUID WERE EVACUATED. HEMATOMA OF THE LEFT PLEURAL CAVITY WAS ALSO OBSERVED, BUT THE SITE OF BLEEDING WAS NOT VISUALIZED. THE INR ON (B)(6) 2023 WAS 3.4; INR ON (B)(6) 2023 WAS 1.4. ON 26 FEBRUARY 2023, INR WAS 1.27. THE PATIENT DID NOT HAVE ANY HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Hematoma; Pleural Effusion; Pulmonary Edema; Thrombosis/Thrombus

  MAUDE report 16522170 ↗
• InjuryJan 5, 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 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS IMPLANTED INTO A PATIENT. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT HAD ATRIAL FIBRILLATION FOUND BY ELECTROCARDIOGRAM (EKG). THE ATRIAL FIBRILLATION REVERTED TO SINUS RHYTHM AFTER TREATMENT OF AMIODARONE BY IV. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16105800 ↗
• DeathDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_992 - VALVED GRAFTS PAS PL5012-183- R723704301. IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM MASTER SERIES, VAVGJ WAS SUCCESSFULLY IMPLANTED IN A 59-YEAR-OLD PATIENT WHO WAS ADMITTED WITH SYMPTOMS OF ACUTE DISSECTION OF THE ASCENDING AORTA, TYPE A. POSTOPERATIVE COURSE WAS COMPLICATED WITH INTRACEREBRAL HEMORRHAGE AND HEMORRHAGE INTO THE SUBARACHNOID SPACE, AND WITH BRAIN OEDEMA AS A CONSEQUENCE. INTENSIVE THERAPY: MECHANICAL VENTILATION, FLUID THERAPY, ANTI-OEDEMIC THERAPY, PARENTERAL FEEDING, TRANSFUSIONS OF BLOOD-DERIVED PREPARATIONS (5 UNITS OF RBCC, 6 UNITS OF FFP, 10 UNITS OF PLATELET CONCENTRATE), WITHOUT SUCCESS. CLINICAL AND RADIOLOGICAL SYMPTOMS OF INJURY OF HIGHER BRAIN CENTERS AND BRAIN STEMS. ON (B)(6) 2022, BEFORE NOON, SEVERAL TEMPORARY BRADYCARDIA EPISODES AND DECREASE IN ARTERIAL BLOOD PRESSURE WERE OBSERVED. AT 1:50 P.M. THE PATIENT¿S DEATH WAS DECLARED DUE TO ACUTE CARDIAC ARREST, ASYSTOLE MECHANISM.

  Patient problems: Bradycardia; Brain Injury; Cardiac Arrest; Intracranial Hemorrhage; Low Blood Pressure/ Hypotension

  MAUDE report 15924069 ↗
• DeathAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM MASTERS SERIES HEART VALSALVA AORTIC VALVE GRAFT WAS CHOSEN FOR PROCEDURE. THE DEVICE WAS IMPLANTED, AND THERE WERE NO DEVICE ISSUES NOTED DURING OR AFTER PROCEDURE. HEPARIN WAS ADMINISTERED DURING PROCEDURE. WHEN FIRST ATTEMPTING TO REMOVE THE PATIENT FROM EXTRACORPOREAL CIRCULATION (ECC), IT WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THE PATIENT HAD BIVENTRICULAR HEART FAILURE. THE PATIENT WAS PLACED ON VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). ON (B)(6) 2022, THE PATIENT'S HEMOGLOBIN WAS LOW, AND MAJOR BLEEDING WAS NOTED DUE TO THE HEART OPERATION AND ANTICOAGULATION THERAPY. MULTIPLE TRANSFUSIONS OF RED BLOOD CELLS, PLATELETS, AND PLASMA WERE GIVEN, AND SURGICAL RE-OPERATION WAS PERFORMED. THE PATIENT PASSED AWAY ON 20 MAY 2022 DUE TO BIVENTRICULAR HEART FAILURE. THE EVENT HAS BEEN CLASSIFIED AS POSSIBLY RELATED TO INADEQUATE CARDIOPLEGIA, THEREFORE THIS EVENT IS BEING CONSERVATIVELY REPORTED.

  Patient problems: Anemia; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15220933 ↗
• InjuryJun 22, 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). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2022, ANEMIA WAS NOTED; THE PATIENT'S HEMOGLOBIN WAS 6.4. THEREFORE, THE PATIENT WAS TRANSFUSED 1 UNIT OF PACKED RED BLOOD CELL (PRBC). NO ACTIVE BLEEDING WAS NOTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Anemia

  MAUDE report 14778664 ↗
• InjuryMay 18, 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 23MM MASTERS SERIES VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, A TEMPORARY PACEMAKER WAS IMPLANTED. POST-OPERATIVELY ON (B)(6) 2022, A JUNCTIONAL RHYTHM WAS OBSERVED, WHICH RESOLVED ON (B)(6) 2022 WITH EVOLUTION IN SINUS RHYTHM WITH RIGHT BUNDLE BRANCH BLOCK (RBBB) AND VENTRICULAR ECTOPICS. THE PATIENT DOES NOT HAVE A PAST MEDICAL HISTORY OF THIS TYPE OF ARRHYTHMIA, BUT HE HAS A HISTORY OF 2 EPISODES OF ATRIAL FIBRILLATION IN 2012. THIS EVENT CAUSED A PROLONGED HOSPITALIZATION. THE PATIENT UNDERWENT OBSERVATION AND SEVERAL ARRHYTHMIA CONSULTANCIES WHICH DID NOT INDICATE ARRHYTHMIA THERAPY WAS REQUIRED. NO MEDICAL OR SURGICAL INTERVENTION WAS GIVEN. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE. THE CAUSE OF THE ARRHYTHMIA AND SUBSEQUENT RBBB WAS NOT POSSIBLE TO DEFINE. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS OR SYMPTOMS.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 14431060 ↗
• InjuryMay 6, 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 23MM SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT WAS SUCCESSFULLY IMPLANTED DUE TO SEVERE AORTIC INSUFFICIENCY. CONCOMITANT PROCEDURES INCLUDED AORTIC ROOT AND ASCENDING AORTA DILATION. DURING SURGERY, AFTER GOING OFF THE PUMP, A RIGHT CORONARY ARTERY BUTTON TEAR OCCURRED. A CORONARY BYPASS WAS PERFORMED. THE CAUSE OF THE BUTTON TEAR WAS THOUGHT TO BE INVOLUNTARY TRACTION OF THE BUTTON. IT WAS NOTED THAT THERE WERE MINOR COMPLICATIONS IN INTENSIVE CARE BUT IT WAS NOT RELATED TO THE BYPASS PROCEDURE. THERE WAS NO DEVICE DEFICIENCY NOTED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Vascular Dissection

  MAUDE report 14304439 ↗
• InjuryJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS THE PHYSICIAN WAS PUTTING SUTURES THROUGH THE SEWING CUFF OF A 23VAVGJ PRODUCT, SEWING CUFF BEGAN TO PULL AWAY FROM VALVE. ¿ IT WAS LIKE THE SEWING CUFF WAS DISINTEGRATING¿. THE VALVE WAS REPLACED WITH A 23 MM ONX VALVED GRAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553938 ↗