BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GIA PRODUCT

    MDR report key: 15896383 · Received December 1, 2022

    Report

    Report Number
    2647580-2022-04374
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    August 15, 2022
    Report Date
    March 22, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PROD: UNKNOWN EEA UNKNOWN EEA LOT # UNK TITLE: HAND-SEWN VERSUS STAPLED SMALL BOWEL ANASTOMOSES IN PATIENTS WITH SECONDARY MESENTERIC ISCHEMIA SOURCE: JOURNAL OF SURGICAL RESEARCH JANUARY 2023 (281) 52 E5 6 0022-4804/$ E SEE FRONT MATTER ª 2022 ELSEVIER INC. ALL RIGHTS RESERVED. HTTPS://DOI.ORG/10.1016/J.JSS.2022.08.007 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.

    Additional Manufacturer Narrative · 0

    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 LITERATURE, A RETROSPECTIVE STUDY COMPARED HAND-SEWN INTESTINAL ANASTOMOSES WITH STAPLED ANASTOMOSES IN PATIENTS WHO UNDERWENT SMALL BOWEL RESECTION FOR ACUTE MESENTERIC ISCHEMIA BETWEEN JANUARY 2015 AND JUNE 2021. THE PATIENTS WERE DIVIDED INTO THREE GROUPS: GROUP 1: HAND-SEWN ANASTOMOSIS GROUP WITH A COMPETITOR SUTURE, GROUP 2: STAPLED END-TO-SIDE ANASTOMOSIS WITH CIRCULAR STAPLER ANVIL 25MM AND LINEAR STAPLER 80MM TO CLOSE THE ENDS OF THE SMALL BOWEL, GROUP 3: STAPLED SIDE-TO-SIDE ANASTOMOSIS WITH LINEAR STAPLER 80MM. THERE WERE 137 PATIENTS IN THE STUDY: 48 PATIENTS WERE IN GROUP 1, 56 WERE IN GROUP 2 AND 33 WERE IN GROUP 3. COMPLICATIONS INCLUDED ANASTOMOTIC LEAK, PERITONITIS, SEPSIS, AND HEMORRHAGE. ANASTOMOTIC LEAK WAS TREATED WITH REOPERATION. FIVE PATIENTS REQUIRED RESECTION OF THE ANASTOMOSIS AND TWO PATIENT REQUIRED ILEOSTOMY. HEMORRHAGE WAS SELF-LIMITED AND DID NOT REQUIRE REOPERATION. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: PULMONARY EMBOLISMS, MYOCARDIAL INFARCTIONS, PULMONARY ATELECTASIS WITH SUPERIMPOSED BACTERIAL PNEUMONIA, SUPERFICIAL WOUND INFECTIONS, AND SUPERFICIAL PHLEBITIS. FOUR DEATHS OCCURRED IN THIS GROUP AND WERE NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED HAND-SEWN INTESTINAL ANASTOMOSES WITH STAPLED ANASTOMOSES IN PATIENTS WHO UNDERWENT SMALL BOWEL RESECTION FOR ACUTE MESENTERIC ISCHEMIA BETWEEN JANUARY 2015 AND JUNE 2021. THE PATIENTS WERE DIVIDED INTO GROUPS BASED ON APPROACH AND THE LINEAR STAPLER WAS USED TO CLOSE THE THE OPEN ENDS OF THE SMALL BOWEL FOR THE STAPLED END-TO-SIDE ANASTOMOSIS GROUP (GROUP 2) AND FOR THE STAPLED SIDE-TO-SIDE ANASTOMOSIS GROUP (GROUP 3) PERFORMED IN A FUNCTIONAL END-TO-END FASHION. COMPLICATIONS INCLUDED ANASTOMOTIC LEAK MANAGEMENT, ONE CASE OF CONTAINED DEHISCENCE IN PATIENTS WITHOUT SIGNS OF SEPSIS OR POSTOPERATIVE PERITONITIS AND WERE CONSERVATIVELY TREATED.2 CASES OF DEHISCENCE IN PATIENTS WITH SIGNS OF SEPSIS AND PERITONITIS AND WERE TREATED WITH RE SURGERY. RE-OPERATED PATIENTS UNDERWENT RESECTION OF THE ANASTOMOSIS FOLLOWED BY RE-ANASTOMOSIS AND ILEOSTOMY. OTHER ANASTOMOTIC COMPLICATION INCLUDED WAS HEMORRHAGE AND IT WAS A SELF-LIMITED AND DID NOT REQUIRED OPERATION. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: PULMONARY EMBOLISMS, MYOCARDIAL INFARCTIONS, PULMONARY ATELECTASIS WITH SUPERIMPOSED BACTERIAL PNEUMONIA, SUPERFICIAL WOUND INFECTIONS, AND SUPERFICIAL PHLEBITIS. FOUR DEATHS OCCURRED IN THIS GROUP AND WERE NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852311 UNKNOWN GIA PRODUCT STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN GIA PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other| R