BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL UNKNOWN

    MDR report key: 9401722 · Received December 3, 2019

    Report

    Report Number
    2210968-2019-90376
    Event Type
    Injury
    Date Received
    December 3, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 PRODUCTS (STRATAFIX SPIRAL) 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 PRODUCTS (STRATAFIX SPIRAL) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS: CITATION: J SURG ONCOL. (2019);120:1142¿1147. DOI: 10.1002/JSO.25698. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: INTRATHORACIC SIDE-TO-SIDE ESOPHAGOGASTROSTOMY WITH A LINEAR STAPLER AND BARBED SUTURE IN ROBOT-ASSISTED IVOR LEWIS ESOPHAGECTOMY". AUTHORS: FUQIANG WANG MD, HANLU ZHANG MD, YU ZHENG M,D, ZIHAO WANG MD, YINGCAI GENG MD, YUN WANG MD, PHD. CITATION: J SURG ONCOL. (2019);120:1142¿1147. DOI: 10.1002/JSO.25698. THE AUTHORS INTRODUCED THEIR INITIAL EXPERIENCE OF INTRATHORACIC SIDE-TO-SIDE ESOPHAGOGASTROSTOMY WITH A LINEAR STAPLER AND REPORT THE SHORT-TERM OUTCOMES. THIS RETROSPECTIVE STUDY INVOLVES A TOTAL OF 37 PATIENTS (35 MALE AND 2 FEMALE; MEDIAN AGE OF 62.7 YEARS; AGE RANGE: 46-75 YEARS; MEDIAN BMI: 22.1 KG/M2; BMI RANGE: 15.1-29.4) WHO UNDERWENT ROBOT-ASSISTED IVOR LEWIS ESOPHAGECTOMY WITH SIDE-TO-SIDE ESOPHAGOGASTROSTOMY FROM FEBRUARY 2016 TO SEPTEMBER 2018. DURING THE PROCEDURE, THE LINEAR STAPLER (ECHELON FLEX POWERED STAPLER 60 MM; ETHICON) WAS INTRODUCED INTO THE ORIFICE OF THE GASTRIC TUBE AND ESOPHAGEAL STUMP, AND A 4-CM LONG SIDE-TO-SIDE STAPLING PROCEDURE APPLIED TO FORM THE POSTERIOR ASPECT OF THE ANASTOMOSIS. TWO SELF-LOCKING BARBED SUTURES (STRATAFIX SPORAL 3/0; ETHICON) WERE PLACED AT EACH END OF THE REMAINING DEFECT, AND THE DEFECT OF THE WHOLE LAYER WAS CLOSED BY RUNNING SUTURE FROM THE END TO THE MIDDLE (FIGURE 5). AFTER CROSS OVER AT THE MIDDLE, THE RUNNING SUTURES WERE RETRACED TO THEIR OWN ENDS TO EMBED THE ANASTOMOSIS. REPORTED COMPLICATION INCLUDED STENOSIS (N-1), POSTOPERATIVE ANASTOMOTIC LEAKAGE (N-3) WHICH WERE SUCCESSFULLY TREATED WITHOUT OPERATION, AND ANASTOMOTIC FISTULAS (N-3) WERE DEVELOPED AT THE ANASTOMOSED AREA WHICH WERE SUCCESSFULLY TREATED BY DRAINAGE AND/OR IRRIGATION WITHOUT REOPERATION. THE INITIAL RESULTS IMPLY THAT IT IS TECHNICALLY FEASIBLE TO PERFORM INTRATHORACIC GASTROESOPHAGEAL ANASTOMOSIS BY TAKING ADVANTAGE OF A ROBOTIC SYSTEM AND KNOTLESS SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196152 STRATAFIX SPIRAL UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention