BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 18334776 · Received December 15, 2023

    Report

    Report Number
    2647580-2023-05328
    Event Type
    Death
    Date Received
    December 15, 2023
    Date of Event
    May 8, 2023
    Report Date
    December 15, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EEA (LOT#: UNKNOWN); UNKNOWN EEA (LOT#: UNKNOWN) MARCO CATARCI, STEFANO GUADAGNI, FRANCESCO MASEDU, GIACOMO RUFFO, MASSIMO G. VIOLA, FELICE BORGHI, GIANANDREA BALDAZZI, MARCO SCATIZZI. THREE-ROW VERSUS TWO-ROW CIRCULAR STAPLERS FOR LEFTSIDED COLORECTAL ANASTOMOSIS: A PROPENSITY SCOREMATCHED ANALYSIS OF THE ICRAL 2 AND 3 PROSPECTIVE COHORTS. INTERNATIONAL JOURNAL OF SURGERY (2023) 109. HTTP://DX.DOI.ORG/10.1097/JS9.0000000000000480. PAGES 2312¿2323 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 LITERATURE SOURCE OF STUDY PERFORMED BETWEEN (B)(6) 2021, TWO RETROSPECTIVE STUDIES EVALUATED ADVERSE EVENTS BETWEEN TWO-ROW AND THREE-ROW STAPLERS IN PATIENTS WHO UNDERWENT COLORECTAL RESECTION AND ANASTOMOSIS FOR MALIGNANT AND BENIGN DISEASES. TRI-STAPLE CIRCULAR STAPLER WAS USED FOR PATIENTS IN THE THREE-ROW GROUP, WHILE CIRCULAR STAPLER AND COMPETITOR STAPLERS WERE USED IN THE TWO-ROW GROUP. THERE WERE 2799 PATIENTS IN THE STUDY. THERE WERE 22 DEATHS WITHIN 60 DAYS. CAUSE OF DEATH WAS NOT REPORTED. OTHER MAJOR COMPLICATIONS THAT WERE NOT RELATED TO THE DEVICE INCLUDED: PNEUMONIA AND PULMONARY FAILURE, PULMONARY EMBOLISM, ACUTE RENAL FAILURE AND A NEUROLOGIC COMPLICATION. THE STUDY CONCLUDED THAT THE USE OF THE THREE-ROW STAPLER SIGNIFICANTLY REDUCED ANASTOMOTIC LEAK AND MAJOR MORBIDITY RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114192 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death| O SEE NOTE ON H10