BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 9450479 · Received December 11, 2019

    Report

    Report Number
    2210968-2019-90724
    Event Type
    Injury
    Date Received
    December 11, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: JOURNAL ARTICLE ATTACHED. CITATION: OBESITY SURGERY (2018) 28:4087¿4094 / HTTPS://DOI.ORG/10.1007/S11695-018-3465-8 - (B)(4).

    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 (PROLENE 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 PRODUCTS (PROLENE SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: OBESITY SURGERY (2018) 28:4087¿4094 / HTTPS://DOI.ORG/10.1007/S11695-018-3465-8.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC GASTRIC GREATER CURVATURE PLICATION: INTERMEDIATE RESULTS AND FACTORS ASSOCIATED WITH FAILURE." AUTHOR(S): R. GUDAITYTE & K. ADAMONIS & A. MALECKAS. CITATION: OBESITY SURGERY (2018) 28:4087¿4094 / HTTPS://DOI.ORG/10.1007/S11695-018-3465-8. THE AIM OF THIS PROSPECTIVE STUDY WAS TO INVESTIGATE INTERMEDIATE RESULTS AND FACTORS ASSOCIATED WITH FAILURE TO ACHIEVE SATISFACTORY WEIGHT LOSS AFTER LAPAROSCOPIC GASTRIC GREATER CURVATURE PLICATION (LGGCP). BETWEEN OCT 2011 AND NOV 2013, A TOTAL OF 53 PATIENTS UNDERWENT LGGCP. PATIENTS WERE DIVIDED DEPENDING ON EXCESS BODY MASS INDEX LOSS: %BMIL < 50 [N = 31 (N=23 FEMALE, N=8 MALE, MEAN AGE 47.5 ± 9.0 YEARS, MEAN BMI 47.5 ± 5.9 KG/M2)] OR %BMIL = 50 [N = 22 (N=17 FEMALE, N=5 MALE, MEAN AGE 49.7 ± 11.5 YEARS, MEAN BMI 44.7 ± 5.7 KG/M2)]. DISSECTION WITH HARMONIC ACE + SHEARS WITH ADAPTIVE TISSUE TECHNOLOGY (ETHICON ENDO-SURGERY, INC.) WAS STARTED ON THE GREATER CURVATURE 3¿4 CM FROM PYLORUS AND CONTINUED ALL THE WAY TO THE HIS ANGLE, WHERE FUNDUS WAS COMPLETELY MOBILIZED EXPOSING ABDOMINAL ESOPHAGUS AND LEFT CRUS. IN BOTH CASES, THE IMBRICATION OF THE GREATER CURVATURE WAS STARTED 1 CM BELOW CARDIA WITH SEPARATE 2 ¿0¿ PROLENE SUTURES (ETHICON) PLACED 2 CM APART UNTIL THE UPPER PART OF THE ANTRUM (DURING THE FIRST PERIOD) OR 3¿4 CM FROM THE PYLORUS (DURING THE SECOND PERIOD). IN TWO-ROW TECHNIQUE, THE CONTINUOUS RUNNING 2 ¿0¿ PROLENE SUTURE WAS STARTED FROM CARDIA AND PLACED OVER THE SEPARATE STITCHES UNTIL THE PROXIMAL PART OF THE ANTRUM. POSTOPERATIVE COMPLICATIONS INCLUDED OBSTRUCTION IN THE PROXIMAL PART OF STOMACH (N=1) WHICH RESOLVED AFTER CONSERVATIVE TREATMENT; OBSTRUCTION AT THE ANGLE OF THE STOMACH (N=1) WHICH NEEDED REPLICATION; BLEEDING FROM THE INJURY OF GASTROEPIPLOIC ARTERY (N=1) WHICH RELAPAROSCOPY WAS PERFORMED TO STOP BLEEDING; PARTIAL DISRUPTION OF PLICATION (N=10); AND COMPLETE DISRUPTION OF PLICATION (N=4). PATIENTS WITH LGGCP HAD POSTOPERATIVE COMPLICATION RATE 4.9% AND ACHIEVED ONLY MODEST WEIGHT LOSS AFTER 3 YEARS. INCREASED HUNGER WAS AN INDEPENDENT RISK FACTOR ASSOCIATED WITH UNSATISFACTORY WEIGHT LOSS AFTER LGGCP. LONG-TERM FOLLOW-UP DATA ARE NEEDED TO DEFINE THE ROLE OF LGGCP IN THE TREATMENT OF MORBID OBESITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249088 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention