BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON FLEX

    MDR report key: 7029498 · Received November 14, 2017

    Report

    Report Number
    3005075853-2017-06113
    Event Type
    Death
    Date Received
    November 14, 2017
    Date of Event
    October 19, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K141952
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ADDITIONAL INFORMATION RECEIVED: (B)(6) MALE PATIENT, WHO UNDERGOES A VATS LOBECTOMY TO REMOVE A 5CM TUMOR. EPOC, RENAL INSUFFICIENCY, HYPERTENSIVE CARDIOPATHY. PROCEDURE: AFTER DOING SEVERAL FIRINGS, IN THE LAST STEP, WHEN THE DOCTOR PERFORMED THE FIRING AROUND THE LEFT SUPERIOR MEDIASTINIC ARTERY, THE KNIFE IS LAUNCHED BUT, APPARENTLY, THE STAPLES DON¿T COME OUT. OUTCOME: THE PATIENT DIED IN THE OR DUE TO BLOOD LOSS. TEAM IN THE OR: THE SURGEON, WHO IS AN EXPERIENCED SURGEON WITH MORE THAN 4 YEARS OF EXPERIENCE IN VATS PROCEDURES. HE PERFORMS AROUND 3 TO 4 CASES PER WEEK WITH THIS TECHNIQUE AND IS AN ETHICON USER. HE IS USED TO MANIPULATING PVE35A. HE WAS ASSISTED BY ANOTHER SURGEON, WHO IS AN INTERNATIONAL KOL IN THORACIC SURGERY WHO HAS EQUALLY, A BROAD EXPERIENCE IN VATS. THEY PERFORM AROUND 80 CASES/YEAR ONLY WITH VATS. 80 MORE WITH OPEN SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT WERE THE INDICATIONS FOR SURGERY? LUNG CANCER SURGERY. WHAT WAS THE ESTIMATED WIDTH OF COMPRESSED PULMONARY ARTERY? 9MM. WAS THE COMPRESSED VESSEL PROXIMAL TO CUT LINE? NO. WAS IT CONFIRMED THAT THERE WAS NO EXTRANEOUS TISSUE IN JAWS DISTAL TO THE CUT LINE? YES. ANY EVIDENCE OF TUMOR INVASION IN THE VESSEL? THERE WAS NOT EVIDENCE OF TUMOR INVASION. WAS THE VESSEL QUALITY COMPROMISED DUE TO THE PATIENT'S DISEASE STATE? NO. BEFORE THE VASCULAR ACCIDENT, THE STAPLER WAS USED IN OTHER BRANCHES WITHOUT PROBLEMS. ANY STAPLES SEEN IN THE OPERATIVE FIELD? IF SO, WHAT WAS THEIR SHAPE? THE STAPLER SEEN WERE FROM OTHER CARTRIDGE FIRED PREVIOUSLY. THEY WERE CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ECHELON VASCULAR PVE35A FAILED TO RECORD AND CUT THE PULMONARY ARTERY, THE MACHINE CUT BUT NOT STAPLED, TORE THE ARTERY AND AS A RESULT, THE PATIENT DIED AT THE SURGERY TABLE. HE LOST 2 OR 3 LITERS OF BLOOD AND IT WAS IMPOSSIBLE TO CONTROL THE HEMORRHAGE. THE MACHINE HAD BEEN USED IN THE SAME INTERVENTION 3 OR 4 TIMES.THIS SERVICE HAS HAD EXPERIENCE FOR YEARS WITH THE ECHELON AND WITH THE VASCULAR SPECIFICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807098 ECHELON FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death