BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIA

    MDR report key: 14381140 · Received May 12, 2022

    Report

    Report Number
    1219930-2022-01777
    Event Type
    Death
    Date Received
    May 12, 2022
    Date of Event
    March 18, 2022
    Report Date
    July 27, 2022
    Manufacturer
    POLYSUTURE IND COM LTDA
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. ONE SEALED REPRESENTATIVE SAMPLE WITH THE APPROPRIATE PACK AGING WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT UNEXPECTED BLEEDING OCCURRED ALONG THE STAPLE LINE, AND THE PATIENT HAD EXPERIENCED A MEDICAL COMPLICATION AS A RESULT OF DEVICE USAGE. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: FAILURE TO ADVANCE THE HANDLE COMPLETELY MAY RESULT IN INCOMPLETE STAPLE FORMATION, WHICH MAY COMPROMISE THE INTEGRITY OF THE STAPLE LINE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, TWO DAYS AFTER A BILIODIGESTIVE SHUNT AND GASTROENTEROANASTOMOSIS VIA TRANSMESOCOLIC WITH PROXIMAL LOOP THROUGH STAPLER AND PROLENE 4.0 PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE CRITICAL CARE WHERE SHE UNDERWENT CRANIOTOMY AT THE TIME, THERE WAS POST-OPERATIVE COMPLICATION AND THE STAPLE LINE WAS BLEEDING. THERE WAS A TISSUE DAMAGED AND EXTENDED HOSPITALIZATION.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE FIRST PROCEDURE, THE SURGEON PERFORMED ENDOSCOPY THAT SHOWED A LARGE CLOT AT STOMACH LEVEL. THE SURGEON HAD NO DIFFICULTY ON THE DEVICE DURING THE FIRST PROCEDURE. TWO DAYS AFTER A BILIODIGESTIVE SHUNT AND GASTROENTEROANASTOMOSIS VIA TRANSMESOCOLIC WITH PROXIMAL LOOP THROUGH STAPLER AND PROLENE 4.0 PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE CRITICAL CARE WHERE SHE UNDERWENT CRANIOTOMY AT THE TIME. THERE WAS POST-OPERATIVE COMPLICATION AND THE STAPLE LINE WAS BLEEDING BUT NO POOR STAPLE FORMATION. SURGICALLY RE-APPROACHED THE PATIENT AND COMPLETED WITH SUTURE. THERE WAS A TISSUE DAMAGE AND EXTENDED HOSPITALIZATION THEN A DAY AFTER THE PATIENT DIED. THE REPORT OF THE SURGERY TEAM WAS THAT THE DEVICE DID NOT PERFORM ITS FUNCTION PROPERLY, LEADING TO THE NEED FOR SURGICAL RE-APPROACH WITH MANUAL SUTURING DUE TO POSTOPERATIVE BLEEDING/COMPLICATION IN AN ELDERLY PATIENT, WHO ENDED UP UNDERGOING TWO SURGERIES UNNECESSARILY. THE CAUSE OF DEATH WAS ALSO QUESTIONED ABOUT SEPSIS WITH A PROBABLE ABDOMINAL FOCUS, WHOSE TREATMENT WAS STARTED WITH A REGIMEN OF ANTIBIOTIC THERAPY FOR SEPSIS, SINCE ITS CLINICAL WORSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935363 GIA STAPLE, IMPLANTABLE GDW POLYSUTURE IND COM LTDA GIA8038LBR 2123406G

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Female Hospitalization| R| D