BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

    MDR report key: 8056148 · Received November 9, 2018

    Report

    Report Number
    2210968-2018-77077
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (SURGICAL STEEL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (SURGICAL STEEL SUTURE) INVOLVED? CITATION: J THORAC CARDIOVASC SURG 2013; 146:901-5, HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2013.04.033. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "CROSSED WIRING CLOSURE TECHNIQUE FOR BILATERAL TRANSVERSE THORACOSTERNOTOMY IS ASSOCIATED WITH LESS STERNAL DEHISCENCE AFTER BILATERAL SEQUENTIAL LUNG TRANSPLANTATION," AUTHORS: THEODOOR D. KOSTER, MD, FAIZ Z. RAMJANKHAN, MD, ED A. VAN DE GRAAF, MD, PHD, BART LUIJK, MD, PHD, DIANA A. VAN KESSEL, MD, RONALD C. A. MEIJER, MD, AND JOHANNA M. KWAKKEL-VAN ERP, MD, PHD. CITATION: J THORAC CARDIOVASC SURG 2013; 146: 901-5, HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2013.04.033. THE PURPOSE OF THIS RETROSPECTIVE COHORT STUDY WAS TO COMPARE THE CONVENTIONAL, UNCROSSED CLOSURE TECHNIQUE WITH THE CROSSED CLOSURE TECHNIQUE REGARDING THE INCIDENCE OF STERNAL DEHISCENCE AND SURGICAL INTERVENTIONS AFTER BILATERAL LUNG TRANSPLANTATION. FROM JANUARY 2001 TO FEBRUARY 2011, 149 PATIENTS UNDERGOING LUNG TRANSPLANTATION VIA CLAMSHELL APPROACH WERE INCLUDED IN THE STUDY. IN 79 PATIENTS; 37 MALES, 47 FEMALES WITH AGE: 42 +/= 13, THE UNCROSSED CLOSURE TECHNIQUE WAS USED TO CLOSE THE BILATERAL TRANSVERSE THORACOSTERNOTOMY 50 PATIENTS; 29 MALES, 59 FEMALES WITH AGE: 44 +/= 14. THERE WERE 71 PATIENTS RECEIVED 2 STEEL WIRES, AND 8 PATIENTS RECEIVED 3 STEEL WIRES; SURGICAL STEEL ETHICON 653B, ETHICON, INC, SOMERVILLE, NJ, WHEREAS THE CROSSED CLOSURE TECHNIQUE WAS USED IN 50 PATIENTS. TO DETERMINE WHETHER PARASTERNALLY CROSSED CLOSURES ARE SUPERIOR TO STERNALLY CROSSED CLOSURES, THE CROSSED CLOSURE GROUP WAS SUBDIVIDED INTO 2 DIFFERENT GROUPS: STERNALLY CROSSED (33 PATIENTS) AND PARASTERNALLY CROSSED (17 PATIENTS). THERE WAS 1 OVERRIDE AND NO SEPARATIONS IN THE PARASTERNALLY CROSSED GROUP, COMPARED WITH 5 OVERRIDES AND 6 SEPARATIONS IN THE STERNALLY CROSSED GROUP. IN 56 (43%) OF THE 129 PATIENTS, STERNAL DEHISCENCE WAS FOUND. AN OVERRIDE WAS DIAGNOSED IN 38 PATIENTS (30%), AND A SEPARATION OF THE STERNUM WAS DIAGNOSED IN 18 PATIENTS (14%). AN OVERRIDE WAS OBSERVED IN 32 (41%) OF THE 79 PATIENTS IN THE UNCROSSED GROUP, AND A SEPARATION OF THE STERNUM WAS OBSERVED IN 12 PATIENTS (15%). IN COMPARISON, 6 (12%) OF THE 50 PATIENTS HAD AN OVERRIDE AND 6 (12%) HAD A SEPARATION OF THE STERNUM IN THE CROSSED GROUP. IN CONCLUSION, CLOSURE OF THE BILATERAL TRANSVERSE THORACOSTERNOTOMY USING THE CROSSED WIRING TECHNIQUE, ESPECIALLY THE PARASTERNALLY CROSSED METHOD, REDUCES THE INCIDENCE OF STERNAL DEHISCENCE. THIS METHOD OF CLOSURE IS ADOPTED IN OUR CLINIC, AND WE RECOMMEND THIS CLOSURE METHOD OVER THE UNCROSSED METHOD TO PREVENT STERNAL DEHISCENCE, WHICH IS DEFINED AS SEPARATION OF THE STERNAL PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895897 SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention