BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6376759 · Received March 3, 2017

    Report

    Report Number
    3005075853-2017-01194
    Event Type
    Death
    Date Received
    March 3, 2017
    Date of Event
    February 4, 2017
    Report Date
    February 24, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND HAS BEEN REVISED TO NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED: IT IS NOT BELIEVED AT THIS TIME THAT THE DEVICE HAD ANY AFFECT RELATED TO THE PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SALES REP WAS IN A CASE WITH THE SURGEON ON 02/06/17 WHEN SHE WAS INFORMED THAT THE PATIENT FROM A DUODENAL SWITCH CASE ON (B)(6) 2017 HAD DIED OVER THE WEEKEND OF (B)(6) 2017. THE SALES REP HAD BEEN PRESENT FOR THE DS CASE. A PLEE60A DEVICE WAS USED WITH GST CARTRIDGES AND GORE SEAMGUARD BUTTRESSING; THE SURGEON DID NOT OVER-SEW ANY OF THE STAPLE LINES. THE CASE WENT WITHOUT ISSUE AND PASSED THE INTRA-OPERATIVE LEAK CHECK. POST-OPERATIVELY, THE PATIENT HAD NO SIGNS OF COMPLICATIONS AND THE SWALLOW TEST WAS NEGATIVE. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND PASSED SOMETIME OVER THE WEEKEND OF (B)(6) 2017. THE SURGEON INFORMED THE SALES REP THAT THE PATIENT HAD A BMI OF 50+ WITH COMORBIDITIES OF DIABETES AND SLEEP APNEA; THE PATIENT SLEPT WITH A CPAP MASK. THE SURGEON SPOKE TO THE PATIENT¿S BROTHER WHO INFORMED HIM THAT THE PATIENT HAD TOLD THE BROTHER THAT SHE DID NOT GET ANY SLEEP IN THE HOSPITAL AND ALL SHE WANTED TO DO WAS SLEEP. IT WAS UNKNOWN IF CPAP WAS USED. THE SALES REP WAS INFORMED THAT A MEDICAL EXAMINER WOULD BE PERFORMING AN AUTOPSY. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT THE PATIENT DEATH IS RELATED IN ANY WAY TO THE STAPLING DEVICE? WAS AN AUTOPSY PERFORMED? IF SO, CAN THE RESULTS BE SHARED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DUODENAL SWITCH PROCEDURE, THE PATIENT DIED. THERE WAS NO PRODUCT COMPLAINT; THE CASE WENT WELL WITH NO ISSUES. THE SURGEON INFORMED THE SALES REP. THE WEEK FOLLOWING THE EVENT. THERE IS NO FURTHER INFORMATION REGARDING THE PATIENT AT THIS POINT IN REGARDS TO AN AUTOPSY, ETC. I BELIEVE THAT ONE IS BEING PERFORMED BY A MEDICAL EXAMINER. THE PATIENT DID HAVE SLEEP APNEA. THERE WAS NO OFFICIAL PRODUCT COMPLAINT AND THE DEVICE PERFORMED AS DESIGNED WITH NO ISSUES. I WAS PRESENT IN THE CASE AND OBSERVED NO ISSUES WITH THE DEVICE. THE SURGEON HAD NO FURTHER INFORMATION AT THAT TIME AND THE CAUSE OF DEATH WAS NOT KNOWN AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158918 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death