BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7786087 · Received August 15, 2018

    Report

    Report Number
    2210968-2018-75190
    Event Type
    Injury
    Date Received
    August 15, 2018
    Report Date
    July 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. CITATION: OBES SURG (2012) 22:863¿865, DOI 10.1007/S11695-011-0567-Y, PUBLISHED ONLINE: 6 DECEMBER 2011. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : EVOLVING PATTERN OF LAPAROSCOPIC GASTRIC BAND ACCESS PORT COMPLICATIONS". AUTHOR: CHEK HENG TOG , JEFFREY HALLIDAY , YET KHOR , TUCK YONG , STEPHEN WILKINSON. CITATION: OBES SURG (2012) 22:863¿865, DOI 10.1007/S11695-011-0567-Y, PUBLISHED ONLINE: 6 DECEMBER 2011. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE RATE AND TIME-COURSE OF ACCESS PORT OR TUBING (AP/T) COMPLICATIONS DURING LAPAROSCOPIC GASTRIC BANDING (LGB). ALL PATIENTS WHOSE LGB PROCEDURE AND AP/T REVISION WERE BOTH PERFORMED BY ONE SURGEON (FROM 1999 TO 2008) WERE INCLUDED, GIVING 167 AP/T REVISIONS IN 124 PATIENTS (113 FEMALES, 11 MALES; TWO, NOT INCLUDED, WERE LOST TO FOLLOW-UP) OUT OF A TOTAL OF 1,928 LGB PATIENTS (1,562 FEMALES, 366 MALES). DURING THE PROCEDURE, ALLERGANTM 10 CM, VANGUARD, APS OR APL WERE INSERTED VIA SIX PORTS USING THE PARS FLACCIDA APPROACH, WITH THREE 2/0 ETHIBONDTM ANTERIOR GASTRO-OESOPHAGEAL FIXATION SUTURES OVER THE FRONT OF THE BAND. BAND TUBING WAS BROUGHT OUT THROUGH THE LEFT LOWER PORT WOUND AND THE INJECTION PORT SUTURED WITH 0/0 ETHIBONDTM (LATER HALF OF CASES) OR 2/0 PROLENETM (EARLIER HALF OF CASES) TO THE LEFT ANTERIOR RECTUS SHEATH. IV CEPHALOTHIN 2 G WAS GIVEN ON ANAESTHETIC INDUCTION, AND 160 MG GENTAMICIN WAS INSTILLED INTO THE ACCESS PORT (AP) WOUND PRIOR TO CLOSURE WITH SUBCUTICULAR VICRYLTM. PORT FLIP WAS MANAGED BY RE-SUTURE OF THE SAME PORT WITH 0/0 ETHIBONDTM BACK ONTO THE LEFT RECTUS SHEATH. THE 77 AP PROBLEMS WERE DUE TO: AP INFECTION (17%), AP LEAKAGE (26%) AND AP FLIPPING (57%). TYPES OF AP INFECTION WERE: ACUTELY INFECTED HAEMATOMA, CHRONIC DISCHARGING SINUS AND AP EROSION THROUGH THE SKIN. THE 82 LGB TUBING COMPLICATIONS WERE EITHER LEAKAGE (64 CASES, 78%) OR BLOCKAGE OF TUBING. THUS, LEAKAGE FROM THE TUBING WAS MUCH COMMONER THAN LEAKAGE FROM PORTS. THE 78% TUBING LEAKAGES WERE CLASSIFIED BY SITE OF LEAK ON THE TUBING: AP TO ABDOMINAL WALL (31%); ABDOMINAL WALL TRANSIT (12%); PERI-CONNECTOR (35%) AND INTRA-ABDOMINAL (7%). THE SITE OF 10% OF LEAKS WAS NOT RECORDED. LEAKAGE OVERALL (20 AP LEAKS AND 78 TUBING LEAKS) THUS CONSTITUTED 98/159 OR 62% OF ALL AP/T PROBLEMS. INDICATIONS FOR AP/T REVISIONS WERE: AP COMPLICATIONS, TUBING COMPLICATIONS AND 'OTHER' (EIGHT CASES, 5%¿FOUR CASES DUE TO KINKS OR TWISTS AND FOUR CASES WERE MISIDENTIFICATION OF THE AP. WHILST THE TECHNIQUES OF KEEPING THE ROUTE OF TUBING THROUGH THE ABDOMINAL WALL MINIMALLY CURVED AND OF ¿WALKING¿ UP THE NEEDLE FROM INFERIOR TO THE AP DURING ADJUSTMENT TO MISS THE AP SHAFT AND TUBING ARE SENSIBLE PREVENTATIVE STEPS, IT IS LIKELY THAT A CHANGE IN MATERIALS AND DESIGN OF THE AP MAY BE NECESSARY TO REDUCE THE LEAKAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627012 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention