BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON FLEX 60 LONG

    MDR report key: 8906304 · Received August 19, 2019

    Report

    Report Number
    3005075853-2019-21337
    Event Type
    Death
    Date Received
    August 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002444
    PMA / PMN Number
    K081146
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). CORRESPONDENCE BETWEEN SURGEON AND COMPANY MEDICAL DIRECTOR: SURGEON ASKED IS IT POSSIBLE THAT A STAPLE LINE INSUFFICIENCY APPEARED POST-MORTEM DUE TO POST-MORTEM PROCESSES? ETHICON HAS NOT CONDUCTED ANY STUDIES ON STAPLE LINE INSUFFICIENCY DUE TO THE POST-MORTEM PROCESS. HOWEVER, WE PERFORMED A LITERATURE SEARCH USING THE KEYWORDS ¿STAPLE LINE¿, ¿INSUFFICIENCY DEFICIENCY¿, ¿INADEQUACY¿, ¿POST MORTEM¿, ¿AUTOPSY¿ AND ¿PM¿. THIS SEARCH DID NOT RESULT IN ANY RELEVANT LITERATURE ON THIS TOPIC.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). ADDITIONAL INFORMATION RECEIVED: THE FOLLOWING EIGHT LOT FOR LONG60A DEVICES WERE SUPPLIED TO THE (B)(6) HOSPITAL WITHIN THE LAST 3 YEARS BEFORE THE INCIDENT OCCURRED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBERS AND NO NON-CONFORMANCES WERE IDENTIFIED. N91C8K DATE OF MFG. 2016-05-09 EXP. DATE 2019-04-30; P91K3K DATE OF MFG. 2017-02-24 EXP. DATE 2020-01-31; P91Z65 DATE OF MFG. 2017-03-29 EXP. DATE 2020-02-29; P91T5U DATE OF MFG. 2017-03-13 EXP. DATE 2020-02-29; P94D8F DATE OF MFG. 2017-11-23 EXP. DATE 2020-10-31; R93M7J DATE OF MFG. 2018-06-18 EXP. DATE 2021-05-31. R9428F DATE OF MFG. 2018-08-02 EXP. DATE 2021-07-31; T92X98 DATE OF MFG. 2019-04-04 EXP. DATE 2022-03-31.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE OF EVENT IS NOT KNOWN. BATCH # UNK. 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 REQUESTED AND RECEIVED: WHAT WAS THE PATIENT¿S BMI? 44.7. IS THE PRODUCT CODE OF CARTRIDGES USED FOR SLEEVE KNOWN? NOT AVAILABLE RIGHT NOW, BUT HE REQUESTED THE PRODUCT CODES OF THE OR TEAM AND WILL SUPPLY THEM UPCOMING WEEK. WAS BUTTRESSING MATERIAL USED? NO. DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? YES. WERE ANY STAPLE FORMATION ISSUES NOTED INTRAOPERATIVELY? NO. WERE ANY DIFFICULTIES EXPERIENCED WITH DEVICE DURING PROCEDURE? NO. ARE PHOTOS OR VIDEO OF PROCEDURE AVAILABLE? NO. HOW DID AUTOPSY CONFIRM INSUFFICIENT STAPLE LINE? NOT. CAN AUTOPSY RESULTS BE SHARED? NOT AVAILABLE AT THE MOMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT SLEEVE GASTRECTOMY. SHE HAD BEEN RELEASED FROM HOSPITAL WITH SLIGHTLY INCREASED INFLAMMATION VALUES. FAMILY PHYSICIAN ALSO CHECKED THIS, BUT SAW NO NEED FOR ACTION. APPARENTLY, SHE HAD BEEN RELEASED FROM HOSPITAL WITH SLIGHTLY INCREASED INFLAMMATION VALUES AND VISITED HER FAMILY PHYSICIAN TO FOLLOW-UP. FAMILY PHYSICIAN SAW NO NEED FOR ACTION. PATIENT DID NOT DIE ON 5TH DAY AFTER SURGERY BUT WAS RELEASED FROM HOSPITAL ON THAT DAY. SHE DIED ON 10TH POST-OP DAY (+/- 1 DAY) AT HOME AFTER SHE HAD VISITED HER DOCTOR. AUTOPSY SHOWED PERITONITIS IN ADDITION TO STAPLE LINE INSUFFICIENCY. THE DOCTOR ASSUMES PULMONARY EMBOLISM AND POST MORTEM DECOMPOSITION PROCESS. LONG60A HAD BEEN USED TOGETHER WITH APPROPRIATE ECR RELOADS. AUTOPSY SHOWED INSUFFICIENT STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701744 ECHELON FLEX 60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036002444

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNKNOWN RELOAD FOR ECHELON 60| UNKNOWN RELOAD FOR ECHELON 60