BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEK DUO VENO-VENOUS CANNULA 31 FR

    MDR report key: 13541351 · Received February 16, 2022

    Report

    Report Number
    2531527-2022-00012
    Event Type
    Death
    Date Received
    February 16, 2022
    Report Date
    February 13, 2022
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. CARDIACASSIST INC. MANUFACTURES THE PROTEKDUO CANNULA. THE INCIDENT OCCURRED IN (B)(6). A MEDICAL ASSESSMENT OF THE CASE WAS CONDUCTED. THE REPORTED SYNDROME IS NOT RELATED TO ANY SPECIFIC PRODUCT MALFUNCTION AND IS RELATED TO THE USE OF CANNULA. IN ADDITION, THIS TYPE OF EVENT DEPENDS ON CANNULA SIZE SELECTED FOR PATIENT VESSEL CONFORMATION. THE SYNDROME CAN BE SOLVED ONLY BY ADDITIONAL MEDICAL INTERVENTION OR BY REMOVAL OF THE OBSTRUCTION. DEATH OF PATIENT IS NOT RELATED TO SVC SYNDROME BUT DUE TO MULTIORGAN FAILURE OF THE PATIENT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.10: SVC SYNDROME CAN BE MULTI-FACTORIAL. DUE TO THE RIGHT INTERNAL JUGULAR VEIN INSERTION OF THE PROTEKDUO CANNULA, SVC SYNDROME MAY RESULT AND IT IS AN INHERENT RISK OF THE PROCEDURE. LOT NUMBER OF THE INVOLVED CANNULA WAS NOT STATED, THUS DHR REVIEW COULD NOT BE PERFORMED. BASED ON GATHERED INFORMATION AND CONSIDERING THAT, AS STATED IN SECTION B.5 OF THE INITIAL REPORT, PATIENT SVC LENGHT WAS CONSIDERED TO BE "SHORTER" THAN COMPARED TO OTHER PATIENT, A RELATIONSHIP BETWEEN A DEVICE MALFUNCTION AND THE SVC SYNDROME CAN BE EXCLUDED. THUS, THE REPORTED SVC SYNDROME IS MORE LIKELY ASSOCIATED TO PATIENT VESSELS CONFORMATIONS. AS STATED IN THE INITIAL REPORT, DEATH OF PATIENT IS NOT RELATED TO SVC SYNDROME BUT DUE TO MULTIORGAN FAILURE OF THE PATIENT.

    Description of Event or Problem · 0

    THROUGH LITERATURE REVIEW LIVANOVA BECAME AWARE OF A (B)(6) FEMALE PATIENT SUPPORTED WITH THE PROTEKDUO 31 FR. FOR RV DYSFUNCTION FOLLOWING HEARTWARE LVAD IMPLANT. THE PATIENT EXPERIENCED SVC (SUPERIOR VENA CAVA) SYNDROME AND WAS DETERMINED TO HAVE A ¿SHORTER¿ SVC LENGTH THAN COMPARED TO OTHER PATIENTS IN THE COHORT IN EXAM, WHICH MAY HAVE CONTRIBUTED TO THE SVC SYNDROME SYMPTOMS. THE PATIENT WAS TREATED WITH THE ADDITION OF A DRAINAGE CANNULA WHICH RESULTED IN RAPID RESOLUTION OF SYMPTOMS AND SHE TOLERATED THE RV SUPPORT WELL. THE REMAINDER OF HER HOSPITAL COURSE WAS COMPLICATED BY MULTISYSTEM ORGAN FAILURE AND RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY. THERE WAS NO IMPROVEMENT IN HER CLINICAL STATUS AFTER 43 DAYS, AND THE PATIENT¿S FAMILY OPTED TO WITHDRAW SUPPORT AND SHE SUBSEQUENTLY DIED. THE AUTHORS BELIEVE THAT ANATOMIC VARIABILITY IN SVC LENGTH AS WELL AS CANNULA SIZE CHOICE ARE LIKELY UNDERLYING CONTRIBUTORS TO THE DEVELOPMENT OF IATROGENIC SVC SYNDROME. OTHER METRICS SUCH AS DIAMETER (ANTEROPOSTERIOR AND LATERAL) AND AREA DID NOT DEMONSTRATE A CORRELATION BETWEEN SIZE AND SVC SYNDROME SECONDARY TO OBSTRUCTION.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17146 PROTEK DUO VENO-VENOUS CANNULA 31 FR CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIACASSIST INC. 5140-5131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O