SJM Masters Series HP Gelweave ValsalvaRecalls & reported problems across all models

We found 5 models of SJM Masters Series HP Gelweave Valsalva by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2019 and Jul 26, 2024 — classified as 7 deaths, 67 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SJM Masters Series HP Gelweave Valsalva problems

SJM Masters Series HP Gelweave Valsalva models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SJM™ Masters Series HP Gelweave Valsalva 25VAVGJ-515

  HEART-VALVE, MECHANICAL
  2 deaths23 reports
• SJM™ Masters Series HP Gelweave Valsalva 23VAVGJ-515

  HEART-VALVE, MECHANICAL
  3 deaths20 reports
• SJM™ Masters Series HP Gelweave Valsalva 27VAVGJ-515

  HEART-VALVE, MECHANICAL
  17 reports
• SJM™ Masters Series HP Gelweave Valsalva 21VAVGJ-515

  HEART-VALVE, MECHANICAL
  2 deaths10 reports
• SJM™ Masters Series HP Gelweave Valsalva 29VAVGJ-515

  HEART-VALVE, MECHANICAL
  7 reports

Recent SJM Masters Series HP Gelweave Valsalva adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls