PROTEK DUO VENOUS CANNULA
Report
- Report Number
- 2531527-2025-20002
- Event Type
- Death
- Date Received
- June 16, 2025
- Date of Event
- January 1, 2025
- Report Date
- April 22, 2026
- Manufacturer
- CARDIAC ASSIST INC.
- Product Code
- DWF
- PMA / PMN Number
- K140999
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE LOT NUMBER IS UNKNOWN, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER AND EXPIRY DATE ARE NOT AVAILABLE H.4. AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H11: LIVANOVA MANUFACTURES THE PROTEK DUO CANNULA. THE INCIDENT OCCURRED IN (B)(6). AS ADDITIONAL INFORMATION REPORTED IN THE RECEIVED MEDTWATCH REPORT: DUE TO PATIENT INCREASED CHEST TUBE OUTPUT (FIRST PRIMARILY FROM LEFT PLEURAL TUBE AT APPROXIMATELY 200CC/HR AND SUBSEQUENTLY FROM THE MEDIASTINAL TUBES AS WELL) A MASSIVE BLOOD TRANSFUSION WITH EQUAL PRBC (PACKED RED BLOOD CELLS), FFP (FRESH FROZEN PLASMA) AND PLATELETS WERE STARTED AND ESCALATION OF PRESSORS. IN ADDITION, TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) WAS DONE WHICH SHOWED THAT THE NEWLY PLACED PROTEK DUO CANNULA WAS IN THE RV (RIGHT VENTRICLE) WITH WHAT LOOKED LIKE AN RV INJURY PRESENT. AFTER SPEAKING WITH PATIENT'S FAMILY IT WAS AGREED NOT TO PROCEED WITH A FURTHER SURGERY. THEREFORE, ANY COAGULOPATHY WAS CORRECTED AND DESPITE THIS, THE BLEEDING CONTINUED. THEN, IT WAS AGREED TO PROCEED WITH COMFORT CARE MEASURES. THE PATIENT'S FOLLOWING CONDITION NECESSITATING CRITICAL CARE MANAGEMENT: ACIDOSIS, ACUTE BLOOD LOSS ANAEMIA, 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. AS PER LIVANOVA MEDICAL EXPERTS' OPINION, THE INJURY (BLEEDING) IS AT THE CANNULA INSERTION SITE. THIS MAY BE RELATED TO THE USED INSERTION TECHNIQUE OR TO CANNULA MIGRATION. HOWEVER, AT THE MOMENT THERE IS NO EVIDENCE, AND NO DEFINITIVE CONCLUSION CAN BE REACHED AROUND THE RELATIONSHIP BETWEEN INJURED TISSUE AND THE DEVICE. MOREOVER, BASED ON INFORMATION PROVIDED, ALSO THE SUCTION OF THE IMPELLA (NON LIVANOVA DEVICE) GENERATING EXCESSIVE NEGATIVE PRESSURE MAY HAVE CAUSED THE INJURY TO THE RIGHT VENTRICLE AS THE PROCEDURE WAS FOR IMPELLA DEVICE REPLACEMENT. REGARDING THE ULTIMATE CAUSE OF PATIENT DEATH, MEDICAL ASSESSMENT OUTCOME IS THAT IT WAS LIKELY CAUSED BY ALL OTHER SERIOUS PATIENT CONDITIONS (E.G. COVID; MYCOBACTERIA INFECTION; CORONARY HEART DISEASE; DIABETES; HEPATIC/RENAL DYSFUNCTION; HYPERTENSION; IMMUNO-COMPROMISED; MORBIDLY OBESE; OTHER) AND THAT MOST LIKELY THE BLEEDING WAS NOT THE MAIN CAUSE OF THE DEATH. INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
H10: RELATED MEDWATCH REPORT NUMBER HAS BEEN ADDED INTO THE DEDICATED SECTION.
G1: UPDATE OF G1 CONTACT OFFICE - MANUFACTURING SITE TO CARDIAC ASSIST INC. [2531527] WITH RESPECT TO PREVIOUS FOLLOW-UP REPORT #2531527-2025-20002.
H11: COMPLAINTS DATABASE REVIEW REVEALED NO CONCERNING TREND HIGHLIGHTED FOR THE REPORTED FAILURE MODE. AS REPORTED IN PRODUCT INSTRUCTIONS FOR USE IFU, POTENTIAL ADVERSE EFFECTS THAT MAY BE ASSOCIATED WITH VENOUS CANNULATION INCLUDE THE INJURY TO OR PERFORATION OF THE MYOCARDIAL WALL WITH OR WITHOUT CARDIAC TAMPONADE. BASED ON THE AVAILABLE INFORMATION, NO EVIDENCE OF MALFUNCTION OF THE PROTEKDUO DEVICE WAS IDENTIFIED. PATIENT'S DEATH WAS LIKELY CAUSED BY HIS SERIOUS CONDITIONS (E.G. COVID; MYCOBACTERIA INFECTION; CORONARY HEART DISEASE; DIABETES; HEPATIC/RENAL DYSFUNCTION; HYPERTENSION; IMMUNO-COMPROMISED; MORBIDLY OBESE; OTHER), THEREFORE BLEEDING WAS NOT THE MAIN CAUSE OF THE DEATH. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.
LIVANOVA RECEIVED A MEDWATCH REPORT (B)(4) REPORT RELATED TO A PROTEK DUO CANNULA 29FR. PATIENT DEVELOPED A PROGRESSIVE DYSPNOEA FOLLOWING COVID INFECTION. A SURFACE ECHOCARDIOGRAM REVEALED PROGRESSION TO SEVERE MITRAL STENOSIS. TRANSOESOPHAGEAL 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 (REPLACEMENT OF IMPELLA WITH PROTEK DEVICE IN THE RIGHT VENTRICLE OF THE HEART). PATIENT WAS ADMITTED PREOPERATIVELY FOR COMPLETION OF PREOPERATIVE TESTING. PATIENT UNDERWENT THE SURGERY FOR REPLACEMENT OF IMPELLA (NON LIVANOVA DEVICE) WITH PROTEK DUO CANNULA IN THE RIGHT HEART. APPROXIMATELY ONE 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 THEN 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. PATIENT DEAD.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009468 | PROTEK DUO VENOUS CANNULA | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | CARDIAC ASSIST INC. | PROTEK DUO ECLS CANNULA 29FR | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Death |