BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8386634 · Received March 4, 2019

    Report

    Report Number
    2210968-2019-79221
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    February 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    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. IF FURTHER DETAILS ARE RECEIVED AT THE 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 (ETHIBOND, PROLENE OR VICRYL 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 (ETHIBOND, PROLENE OR VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: YONSEI MED J. 2017; 58(5): 1025-1030. DOI: HTTPS://DOI.ORG/10.3349/YMJ.2017.58.5.1025.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : SHORT-TERM OUTCOMES OF LAPAROSCOPIC GREATER CURVATURE PLICATION AND LAPAROSCOPIC SLEEVE GASTRECTOMY IN PATIENTS WITH A BODY MASS INDEX OF 30 TO 35 KG/M2." AUTHOR: YEON HO PARK AND SEONG MIN KIM. CITATION: YONSEI MED J. 2017; 58(5): 1025-1030. DOI: HTTPS://DOI.ORG/10.3349/YMJ.2017.58.5.1025. THE AIM OF THIS STUDY WAS TO COMPARE THE MIDTERM OUTCOMES OF LAPAROSCOPIC GREATER CURVATURE PLICATION (LGCP) AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IN OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF 30 TO 35 KG/M2. THIS SINGLE CENTER, RETROSPECTIVE REVIEW OF PROSPECTIVELY COLLECTED DATA WAS CONDUCTED FOR 149 OBESE PATIENTS THAT UNDERWENT LGCP (GROUP A; 75 PATIENTS; 8 MALE AND 67 FEMALE PATIENTS; AGE: 32.6 ± 6.7; BMI: 33.7 ± 3.3) OR LSG (GROUP B; 74 PATIENTS; 16 MALE AND 58 FEMALE PATIENTS; AGE: 30.4 ± 7.9; BMI: 34.7 ± 53.6) FROM MARCH 2013 TO FEBRUARY 2016. DURING THE LGCP SURGICAL PROCEDURE (GROUP A), GASTRIC INFOLDING WAS PERFORMED USING TWO LAYERS OF ETHIBOND NON-ABSORBABLE SUTURES (ETHICON) AND OUTER CONTINUOUS SUTURES OF PROLENE 2-0 SUTURES (ETHICON). THE FIRST ROW OF SUTURES WAS STARTED 2 CM BELOW THE GASTROESOPHAGEAL JUNCTION AND CONTINUED UNTIL 3¿4 CM PROXIMAL TO THE PYLORUS. DURING THE LSG SURGICAL PROCEDURE (GROUP B), AFTER GASTROLYSIS OF THE GREATER OMENTUM FROM THE GREATER CURVATURE, A BOUGIE (36 OR 40 FR) WAS INSERTED TO GUIDE GASTRIC RESECTION, WHICH WAS PERFORMED USING FIVE TO SEVEN 60 MM STAPLES. A SEROSAL REINFORCEMENT SUTURE WAS PLACED USING VICRYL 2-0 SUTURES (ETHICON). IN GROUP A, REPORTED COMPLICATIONS INCLUDED GASTRIC OBSTRUCTION (N-3) WHICH REQUIRED CONSERVATIVE TREATMENT IN 2 PATIENTS AND UNDO PLICATION IN 1 PATIENT AND A PATIENT WITH POSITIVE TEST FOR HELICOBACTER PYLORI AND MUCOSAL BLEEDING WHICH REQUIRED TRANSFUSION. IN GROUP B, REPORTED COMPLICATIONS INCLUDED GASTRIC STENOSIS (N-1) WHICH REQUIRED CONSERVATIVE TREATMENT AND PROXIMAL LEAK WITH SEVERE FEVER AND ABDOMINAL PAIN (N-1) WHICH REQUIRED CONSERVATIVE TREATMENT. IN CONCLUSION, THE PRESENT STUDY SHOWS THAT MEAN WEIGHT LOSS AFTER LGCP, IN PATIENTS WITH BMIS RANGING FROM 30 TO 35 KG/M2, IS INFERIOR TO THAT AFTER LSG, ESPECIALLY AFTER THE FIRST SIX POSTOPERATIVE MONTHS. NONETHELESS, WEIGHT LOSSES WERE STILL ACCEPTABLE, THE RESOLUTION RATE OF METABOLIC COMORBIDITIES WAS EXCELLENT, AND ACUTE AND CHRONIC COMPLICATION RATES WERE SATISFACTORY AND COMPARABLE TO LSG DURING THE FIRST THREE POSTOPERATIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179622 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOUGIE| STAPLER