BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7762150 · Received August 8, 2018

    Report

    Report Number
    2210968-2018-75000
    Event Type
    Death
    Date Received
    August 8, 2018
    Report Date
    July 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WAS THIS CASE PREVIOUSLY REPORTED TO ETHICON? O IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 2. PLEASE SPECIFY WHAT THE QUALITY ISSUE WAS WITH THE PRODUCT? 3. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? 4. DOES THE SURGEON BELIEVE THAT ETHICON SUTURE CAUSED/ CONTRIBUTED TO THE DEATH (DUE TO SEPSIS)? 5. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCT (ETHIBOND OR PROLENE SUTURE) USED IN THIS PROCEDURE? 6. WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING (TRANSLATION IS AVAILABLE)? THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 3. SPECIFY WHAT THE PATIENT CONSEQUENCE WAS? 4. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? O IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED? IF YES, PLEASE INCLUDE: DATE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE? 5. WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED? CITATION: THORAC CARDIOVASC SURG 2016;64:116¿123; DOI HTTP://DX.DOI.ORG/10.1055/S-0035-1552580. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : IS BENTALL PROCEDURE STILL THE GOLD STANDARD FOR ACUTE AORTIC DISSECTION WITH AORTIC ROOT INVOLVEMENT? AUTHOR: ERIK BECKMANN1,_ ANDREAS MARTENS1,_ FIRAS ABD ALHADI1 FABIO IUS1 NURBOL KOIGELDIYEV1 FELIX FLEISSNER1 PENELOPE STIEFEL1 TIM KAUFELD1 AXEL HAVERICH1 MALAKH SHRESTHA1 CITATION: THORAC CARDIOVASC SURG 2016;64:116¿123; DOI HTTP://DX.DOI.ORG/10.1055/S-0035-1552580. THE STUDY AIMED TO COMPARE THE OUTCOME OF VALVE-SPARING AORTIC ROOT SURGERY (DAVID I) WITH THE OUTCOME OF BENTALL PROCEDURES WITH MECHANICAL AND TISSUE VALVED CONDUITS IN THE SETTING OF ACUTE AORTIC DISSECTION TYPE A (AADA). BETWEEN JAN2002 AND JUL2011, 119 PATIENTS WITH AADA UNDERWENT SURGERY AND WERE CLASSIFIED ACCORDING TO THE PROCEDURE: GROUP 1 (N=31; AGE OF 71 YEARS [67-76 YEARS]) RECEIVED A BENTALL PROCEDURE WITH TISSUE-VALVED CONDUIT, GROUP 2 (N=41; AGE OF 62 YEARS [53-69 YEARS]) RECEIVED A BENTALL PROCEDURE WITH MECHANICAL CONDUIT, AND GROUP 3 (N=47; AGE OF 52 YEARS [46-61 YEARS]) UNDERWENT AORTIC VALVE-SPARING DAVID I PROCEDURE. IN THE VALVE-SPARING AORTIC ROOT TECHNIQUE, 9-12 THREADS OF 2/0 COATED ETHIBOND SUTURES WERE PLACED INSIDE-OUT HORIZONTALLY BELOW THE VALVE IN A CIRCUMFERENTIAL WAY AND ANCHORED IN THE DACRON PROSTHESIS. THE DACRON GRAFT WAS FIXED WITHIN USING 4/0 PROLENE SUTURES INCLUDING THE REMNANTS OF THE AORTIC SINUSES AND THE AORTIC ANNULUS INTO THE STRAIGHT GRAFT. THE CORONARY OSTIA WERE REIMPLANTED TO THEIR RESPECTIVE NEOSINUSES USING 5/0 POLY-PROLENE SUTURE. IN THE BENTALL TECHNIQUE (TISSUE-VALVED, MECHANICAL CONDUITS), THE CONDUIT WAS IMPLANTED INTO THE AORTIC ANNULUS USING ETHIBOND SUTURES AND CORONARY OSTIA WERE REPLANTED INTO THE CONDUIT USING 5/0 POLLY-PROLENE SUTURES. IN A 30-DAY MORTALITY, TWO PATIENTS FROM GROUP 2 DIED OF SEPSIS, AND TWO PATIENTS FROM GROUP 3 ALSO DIED OF SEPSIS. COMPARED WITH MECHANICAL VALVE CONDUITS, A POSSIBLY HIGHER REOPERATION RATE AFTER DAVID PROCEDURES HAS TO BE WEIGHED AGAINST A HIGHER RISK FOR THROMBOEMBOLIC AND BLEEDING COMPLICATIONS UNDER LIFE-LONG ANTICOAGULATION IN PATIENTS RECEIVING A MECHANICAL VALVE. BENTALL PROCEDURE WITH A TISSUE-VALVED CONDUIT CAN BE CONSIDERED FOR OLDER PATIENTS, BUT IN YOUNGER PATIENTS, VALVE-SPARING ROOT REPLACEMENTS SHOULD BE CONSIDERED IF THE SURGICAL TEAM IS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606067 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death