PROTEK DUO
Report
- Report Number
- 21839659
- Event Type
- Death
- Date Received
- April 15, 2025
- Date of Event
- January 17, 2025
- Report Date
- April 10, 2025
- Manufacturer
- CARDIAC ASSIST, INC.
- Product Code
- DWF
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- 003
Narratives
PATIENT DEVELOPED PROGRESSIVE DYSPNEA FOLLOWING COVID INFECTION [DATE REDACTED]. RECENT SURFACE ECHOCARDIOGRAM REVEALED PROGRESSION TO SEVERE MITRAL STENOSIS. TRANSESOPHAGEAL ECHOCARDIOGRAM WAS CONFIRMATORY FOR SEVERE MITRAL STENOSIS WITH MEAN GRADIENT 12 MMHG WITH SEVERE THICKENING OF THE POSTERIOR GREATER THAN ANTERIOR MITRAL VALVE LEAFLETS AND MITRAL ANNULAR CALCIFICATION. CARDIAC CATHETERIZATION CONFIRMED MODERATE AORTIC AND SEVERE MITRAL STENOSIS WITH MEAN GRADIENT 12 AND 35 MMHG, LEFT MAIN DISEASE EXTENDING INTO THE PROXIMAL LAD [LEFT ANTERIOR DESCENDING]. PATIENT MET IN CONSULTATION WITH DR. AND HAS ELECTED TO UNDERGO SURGICAL INTERVENTION. PATIENT WAS ADMITTED PREOPERATIVELY ON [DATE REDACTED] FOR COMPLETION OF PREOPERATIVE TESTING. ON [DATE REDACTED], PATIENT UNDERWENT REPLACEMENT OF IMPELLA WITH PROTEK DEVICE IN THE RIGHT HEART. APPROX. 1 HOUR AFTER RETURN TO THE CVICU [CARDIOVASCULAR INTENSIVE CARE UNIT] AFTER DEVICE PLACEMENT, THE CHEST TUBE OUTPUT INCREASED DRAMATICALLY, AND PRESSOR REQUIREMENTS ALSO INCREASED. THE PATIENT WAS GIVEN MULTIPLE MASSIVE TRANSFUSION PACKS WHILE THE FAMILY AND SURGICAL TEAM DETERMINED THE BEST PATH FORWARD, AND ULTIMATELY ELECTED TO HAVE THE PATIENT PROCEED WITH COMFORT MEASURES. TRANSFUSIONS WERE STOPPED, AND THE PATIENT PROMPTLY PASSED SECONDARY TO HYPOVOLEMIC SHOCK. CVICU INTENSIVIST NOTE: ANESTHESIOLOGY CRITICAL CARE: WAS CALLED TO BEDSIDE WITH INCREASED CHEST TUBE OUTPUT, FIRST PRIMARILY FROM LEFT PLEURAL TUBE AT APPROXIMATELY 200CC/HR AND SUBSEQUENTLY FROM THE MEDIASTINAL TUBES AS WELL. MASSIVE BLOOD TRANSFUSION WITH EQUAL PRBC [PACKED RED BLOOD CELLS], FFP [FRESH FROZEN PLASMA], PLATELETS WERE STARTED AND ESCALATION OF PRESSORS. TEE [TRANSESOPHAGEAL ECHOCARDIOGRAM] WAS DONE WHICH SHOWED THAT THE NEWLY PLACED PROTEK DUO CATH WAS IN THE RV [RIGHT VENTRICLE] WITH WHAT LOOKED LIKE AN RV INJURY PRESENT. SURGICAL TEAM WAS MADE AWARE AND PRESENT DURING DISCUSSIONS. WE SPOKE WITH FAMILY WHO AGREED THAT FURTHER SURGERY WOULD LIKELY NOT RESULT IN AN OUTCOME AND A QUALITY OF LIFE THAT THE PATIENT WOULD WANT. WE PROCEEDED TO CORRECT ANY COAGULOPATHY AND DESPITE THIS, THE BLEEDING CONTINUED. WE THEN SPOKE WITH FAMILY AND AGREED TO PROCEED WITH COMFORT CARE MEASURES. I PROVIDED 184 MINUTES OF CRITICAL CARE SERVICES WHICH WERE NECESSARY DUE TO THE PATIENT'S FOLLOWING CONDITION NECESSITATING CRITICAL CARE MANAGEMENT: ACIDOSIS, ACUTE BLOOD LOSS ANEMIA, ACUTE KIDNEY INJURY, ARRHYTHMIA, CARDIOGENIC SHOCK, COAGULOPATHY, ELECTROLYTE ABNORMALITIES, HYPOTENSION, HYPOVOLEMIC SHOCK, LIVER FAILURE, MULTISYSTEM ORGAN FAILURE, RENAL FAILURE, THROMBOCYTOPENIA. THE CRITICAL CARE TREATMENT AND MANAGEMENT INCLUDED ALKALI THERAPY, ANTIBIOTICS, BLOOD PRODUCT ADMINISTRATION, CONTINUOUS RENAL REPLACEMENT THERAPY, DISCUSSION OF PATIENT'S CONDITION AND THERAPEUTIC OPTIONS WITH MEDICAL DECISION MAKERS, ELECTROLYTE AND NUTRITION MANAGEMENT, FLUID ADMINISTRATION, INVASIVE HEMODYNAMIC MONITORING, MANAGEMENT OF MECHANICAL VENTILATION, REVIEW OF MEDICAL RECORDS, SEDATION MANAGEMENT, TITRATION OF INOTROPE INFUSIONS, TITRATION OF VASOPRESSOR INFUSIONS, DISCUSSION WITH CONSULTING SERVICES, TITRATION OF ANTICOAGULANTS.
PATIENT DEVELOPED PROGRESSIVE DYSPNEA FOLLOWING COVID INFECTION [DATE REDACTED]. RECENT SURFACE ECHOCARDIOGRAM REVEALED PROGRESSION TO SEVERE MITRAL STENOSIS. TRANSESOPHAGEAL ECHOCARDIOGRAM WAS CONFIRMATORY FOR SEVERE MITRAL STENOSIS WITH MEAN GRADIENT 12 MMHG WITH SEVERE THICKENING OF THE POSTERIOR GREATER THAN ANTERIOR MITRAL VALVE LEAFLETS AND MITRAL ANNULAR CALCIFICATION. CARDIAC CATHETERIZATION CONFIRMED MODERATE AORTIC AND SEVERE MITRAL STENOSIS WITH MEAN GRADIENT 12 AND 35 MMHG, LEFT MAIN DISEASE EXTENDING INTO THE PROXIMAL LAD [LEFT ANTERIOR DESCENDING]. PATIENT MET IN CONSULTATION WITH DR. AND HAS ELECTED TO UNDERGO SURGICAL INTERVENTION. PATIENT WAS ADMITTED PREOPERATIVELY ON [DATE REDACTED] FOR COMPLETION OF PREOPERATIVE TESTING. ON [DATE REDACTED], PATIENT UNDERWENT REPLACEMENT OF IMPELLA WITH PROTEK DEVICE IN THE RIGHT HEART. APPROX. 1 HOUR AFTER RETURN TO THE CVICU [CARDIOVASCULAR INTENSIVE CARE UNIT] AFTER DEVICE PLACEMENT, THE CHEST TUBE OUTPUT INCREASED DRAMATICALLY, AND PRESSOR REQUIREMENTS ALSO INCREASED. THE PATIENT WAS GIVEN MULTIPLE MASSIVE TRANSFUSION PACKS WHILE THE FAMILY AND SURGICAL TEAM DETERMINED THE BEST PATH FORWARD, AND ULTIMATELY ELECTED TO HAVE THE PATIENT PROCEED WITH COMFORT MEASURES. TRANSFUSIONS WERE STOPPED, AND THE PATIENT PROMPTLY PASSED SECONDARY TO HYPOVOLEMIC SHOCK. CVICU INTENSIVIST NOTE: ANESTHESIOLOGY CRITICAL CARE: WAS CALLED TO BEDSIDE WITH INCREASED CHEST TUBE OUTPUT, FIRST PRIMARILY FROM LEFT PLEURAL TUBE AT APPROXIMATELY 200CC/HR AND SUBSEQUENTLY FROM THE MEDIASTINAL TUBES AS WELL. MASSIVE BLOOD TRANSFUSION WITH EQUAL PRBC [PACKED RED BLOOD CELLS], FFP [FRESH FROZEN PLASMA], PLATELETS WERE STARTED AND ESCALATION OF PRESSORS. TEE [TRANSESOPHAGEAL ECHOCARDIOGRAM] WAS DONE WHICH SHOWED THAT THE NEWLY PLACED PROTEK DUO CATH WAS IN THE RV [RIGHT VENTRICLE] WITH WHAT LOOKED LIKE AN RV INJURY PRESENT. SURGICAL TEAM WAS MADE AWARE AND PRESENT DURING DISCUSSIONS. WE SPOKE WITH FAMILY WHO AGREED THAT FURTHER SURGERY WOULD LIKELY NOT RESULT IN AN OUTCOME AND A QUALITY OF LIFE THAT THE PATIENT WOULD WANT. WE PROCEEDED TO CORRECT ANY COAGULOPATHY AND DESPITE THIS, THE BLEEDING CONTINUED. WE THEN SPOKE WITH FAMILY AND AGREED TO PROCEED WITH COMFORT CARE MEASURES. I PROVIDED 184 MINUTES OF CRITICAL CARE SERVICES WHICH WERE NECESSARY DUE TO THE PATIENT'S FOLLOWING CONDITION NECESSITATING CRITICAL CARE MANAGEMENT: ACIDOSIS, ACUTE BLOOD LOSS ANEMIA, ACUTE KIDNEY INJURY, ARRHYTHMIA, CARDIOGENIC SHOCK, COAGULOPATHY, ELECTROLYTE ABNORMALITIES, HYPOTENSION, HYPOVOLEMIC SHOCK, LIVER FAILURE, MULTISYSTEM ORGAN FAILURE, RENAL FAILURE, THROMBOCYTOPENIA. THE CRITICAL CARE TREATMENT AND MANAGEMENT INCLUDED ALKALI THERAPY, ANTIBIOTICS, BLOOD PRODUCT ADMINISTRATION, CONTINUOUS RENAL REPLACEMENT THERAPY, DISCUSSION OF PATIENT'S CONDITION AND THERAPEUTIC OPTIONS WITH MEDICAL DECISION MAKERS, ELECTROLYTE AND NUTRITION MANAGEMENT, FLUID ADMINISTRATION, INVASIVE HEMODYNAMIC MONITORING, MANAGEMENT OF MECHANICAL VENTILATION, REVIEW OF MEDICAL RECORDS, SEDATION MANAGEMENT, TITRATION OF INOTROPE INFUSIONS, TITRATION OF VASOPRESSOR INFUSIONS, DISCUSSION WITH CONSULTING SERVICES, TITRATION OF ANTICOAGULANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121981 | PROTEK DUO | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | CARDIAC ASSIST, INC. | 5140-4629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Death |