BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP

    MDR report key: 9774836 · Received March 2, 2020

    Report

    Report Number
    3005075853-2020-01351
    Event Type
    Death
    Date Received
    March 2, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 5, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014584
    PMA / PMN Number
    K141952
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/30/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: 1. PLEASE CONFIRM THE SURGICAL PROCEDURE. RIGHT PNEUMONECTOMY. 2. WHAT WERE THE INDICATIONS FOR SURGERY? LOCALIZED TUMOR IN THE RIGHT LUNG HILUM. 3. WHAT ANATOMICAL STRUCTURE WAS DEVICE FIRED ON PRIOR TO ARTERY FIRING? MAIN RIGHT PULMONARY ARTERY. 4. WHAT WAS THE APPROXIMATE WIDTH OF PULMONARY ARTERY? 1.7~1.9 CM. 5. WHAT WAS THE EXACT BRANCH OF PULMONARY ARTERY? RIGHT MAIN PULMONARY ARTERY. 6. WHAT IS THE SURGEON¿S EXPERIENCE WITH DEVICE? VERY EXPERT. 7. DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? YES. 8. CAN IT BE CONFIRMED THAT THE ENTIRE WIDTH OF COMPRESSED VESSEL WAS PROXIMAL TO CUT LINE AND NO EXTRANEOUS TISSUE WAS WITHIN JAWS DISTAL TO CUT LINE? YES. 9. PLEASE DESCRIBE CLEANING TECHNIQUE BETWEEN FIRINGS. THE STAPLER IS WASHED BY PUTTING IT IN A PUT THAT CONTAINS NORMAL SALINE AND MAKE SURE THAT THE WHOLE JAW IS BEING WASHED PROPERLY BEFORE EACH RELOAD. 10. PLEASE CONFIRM THAT DEVICE WAS NOT REPROCESSED. YES / NEW ONE UPON THE HOSPITAL POLICES NO DISPOSABLES CAN BE RASTERIZED IN (B)(6) CENTER. 11. WHY WAS THE SUSPECTED REASON FOR BLEED STAPLE MALFORMATION? CAN ANY DETAILS BE PROVIDED OF SHAPE? 5 TO 7 SECONDS AFTER FINISHING FIRING AND REMOVING THE STAPLER, AND MAKING SURE THAT THE STAPLES CLOSED THE WHOLE ARTERY, THE ARTERY OPENED FOR THE STAPLER SIDE AND STARTED TO BLEED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT: 7/14/2020. ADDITIONAL INFORMATION OBTAINED FROM CONVERSATION WITH SURGEON: THE PATIENT WAS A MALE WITH STAGE IIIA CANCER WHO UNDERGONE RADIATION THERAPY 20 MONTHS PRIOR. THE PATIENT HAD A FULL EVALUATION PRIOR TO SURGERY TO CONFIRM NO ADHESIONS AND TUMOR WAS LOCALIZED. THE TISSUE QUALITY SEEMED TO BE ACCEPTABLE. DURING PROCEDURE, VESSEL LOOPS WERE USED, AND THE ARTERY WAS COMPLETELY DISSECTED OUT FOR PROPER DEVICE PLACEMENT. THE SURGEON CONFIRMED THAT THE JAWS OF DEVICE WERE VISIBLE, AND HE WAITED 1-2 MINUTES PRIOR TO FIRING. THE APPROXIMATE WIDTH OF COMPRESSED VESSEL WAS 3CM. AFTER FIRING, THE STAPLE LINE HELD FOR ABOUT 3-5 SECONDS AND THEN OPENED. DUE TO THE AMOUNT OF BLEEDING, THE STAPLE FORM COULD NOT BE OBSERVED. THIS WAS THE 4TH FIRING OF DEVICE DURING THE PROCEDURE. THE SAME DEVICE WAS USED ON THE VEINS WITH NO ISSUES. NO UNUSUAL SOUNDS OR FEEDBACK WERE NOTICED. THE SURGEON STATED THAT IT TOOK 2-3 HOURS TO CONTROL THE BLEEDING AND THE PATIENT WAS GIVEN 16 UNITS OF BLOOD. THE PATIENT EXPIRED 2 DAYS LATER OF ORGAN FAILURE. THE SURGEON CONTINUES TO USE THE PVS DEVICE AND HAS SINCE USED APPROXIMATELY 30 TIMES SINCE THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 3/2/2020. BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CONFIRM THE SURGICAL PROCEDURE. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT ANATOMICAL STRUCTURE WAS DEVICE FIRED ON PRIOR TO ARTERY FIRING? WHAT WAS THE APPROXIMATE WIDTH OF PULMONARY ARTERY? WHAT WAS THE EXACT BRANCH OF PULMONARY ARTERY? WHAT IS THE SURGEON¿S EXPERIENCE WITH DEVICE? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? CAN IT BE CONFIRMED THAT THE ENTIRE WIDTH OF COMPRESSED VESSEL WAS PROXIMAL TO CUT LINE AND NO EXTRANEOUS TISSUE WAS WITHIN JAWS DISTAL TO CUT LINE? PLEASE DESCRIBE CLEANING TECHNIQUE BETWEEN FIRINGS. PLEASE CONFIRM THAT DEVICE WAS NOT REPROCESSED. WHY WAS THE SUSPECTED REASON FOR BLEED STAPLE MALFORMATION? CAN ANY DETAILS BE PROVIDED OF SHAPE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN AN OPEN LUNG LOBOTOMY PROCEDURE, THE DOCTOR USED PVS35A ALONG WITH VASECR35. AFTER THE THIRD FIRE AND DURING THE USE OF THE PRODUCT IN CLOSING THE PULMONARY ARTERY, THE SURGEON FIRED THE STAPLER AND AFTER LESS THAN 60 SECONDS, THE VESSEL STARTED TO BLEED FROM THE STAPLER SITE AND THEN COMPLETE OPEN OF THE VESSEL ALONG WITH HEAVY BLEEDING. THE SURGEON MANAGED TO STOP THE BLEEDING, BUT THE PATIENT LOST AROUND 30 UNIT OF BLOOD AND HE SUFFERED FROM BLOOD PERFUSION AND DIED AFTER THE PROCEDURE IN THE ICU MANUAL COMPRESSION AND AFTER MANAGING THE BLEEDING A HAND SEWING WAS PERFORMED. WE CANT DESCRIBE THE ACTUAL DAMAGE, SUSPECTED REASON IS A MALFORMATION OF THE B-SHAPE OF THE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239965 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PVE35A T94W1P 10705036014584

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death