BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12170947 · Received July 14, 2021

    Report

    Report Number
    2210968-2021-06353
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    April 9, 2020
    Report Date
    July 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (WOUND INFECTION/HEALING DISORDER, OBSTIPATION, FLATULENCE, DIARRHEA, STEATORRHEA, PAIN, NAUSEA, BLOATEDNESS, SYMPTOMATIC BILE REFLUX, ANASTOMOTIC ULCERS, MASSIVE MALABSORPTION SYNDROME, DUMPING SYNDROME, READMISSION, ABSCESS, STAPLE LINE LEAK, INCISIONAL HERNIA AND IN ONE FEMALE PATIENT -SMALL BOWEL OBSTRUCTION)? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PDS II SUTURE) USED IN THIS PROCEDURE/STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (WOUND INFECTION/HEALING DISORDER, OBSTIPATION, FLATULENCE, DIARRHEA, STEATORRHEA, PAIN, NAUSEA, BLOATEDNESS, SYMPTOMATIC BILE REFLUX, ANASTOMOTIC ULCERS, MASSIVE MALABSORPTION SYNDROME, DUMPING SYNDROME, READMISSION, ABSCESS, STAPLE LINE LEAK, INCISIONAL HERNIA AND IN ONE FEMALE PATIENT -SMALL BOWEL OBSTRUCTION) AND DETAILS OF EVENTS IF AVAILABLE. WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: SURGERY FOR OBESITY AND RELATED DISEASES (2020); 16: 1060¿1066. DOI: HTTPS://DOI.ORG/10.1016/J.SOARD.2020.04.014. ADVERSE EVENTS WERE SUBMITTED VIA 2210968-2021-06354.

    Description of Event or Problem · 1

    TITLE: SHORT- TO MEDIUM-TERM RESULTS OF SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS COMPARED WITH ONE-ANASTOMOSIS GASTRIC BYPASS FOR WEIGHT RECIDIVISM AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY. THE AIM OF THIS OBSERVATIONAL STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF SADI AND OAGB AS REVISIONAL BARIATRIC SURGERY (RBS) IN INITIALLY SUPER-OBESE PATIENTS (BODY MASS INDEX [BMI] .50 KG/M2). BETWEEN JULY 2013 AND APRIL 2018, A TOTAL OF 84 INITIALLY SUPER-OBESE PATIENTS UNDERWENT RBS AFTER LSG. OF THESE, 42 PATIENTS (31 FEMALE, 11 MALE; MEAN AGE = 45.1±11.1 YEARS; MEAN BMI = 55.1±12 KG/M2) UNDERWENT A SADI PROCEDURE, IN THE OTHER 42 PATIENTS (28 FEMALE, 14 MALE; MEAN AGE = 47.2±10.8 YEARS; MEAN BMI = 55.6±9.1 KG/M2) AN OAGB WAS PERFORMED. THE SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS (SADI) PROCEDURE WAS PERFORMED USING A 60-MM BLUE CARTRIDGE LINEAR STAPLER (ECHELON FLEX; ETHICON). THE ONE-ANASTOMOSIS GASTRIC BYPASS (OAGB) PROCEDURE WAS PERFORMED USING A 60-MM LINEAR STAPLER (ECHELON FLEX; ETHICON) AND THE CLOSURE OF THE STAPLER ENTRY POINTS WAS PERFORMED THROUGH A 3.0 PDS CONTINUOUS SUTURE (ETHICON). REPORTED COMPLICATIONS INCLUDED WOUND INFECTION/HEALING DISORDER (N=2); OBSTIPATION (N=6); FLATULENCE (N=2); DIARRHEA (N=5); STEATORRHEA (N=2); PAIN, NAUSEA, BLOATEDNESS (N=8); SYMPTOMATIC BILE REFLUX (N=11); ANASTOMOTIC ULCERS (N=1); MASSIVE MALABSORPTION SYNDROME (N=2); DUMPING SYNDROME (N=5); READMISSION (N=18); ABSCESS (N=2); STAPLE LINE LEAK (N=1); INCISIONAL HERNIA (N=2). IN CONCLUSION, BOTH SADI AND OAGB WERE EFFECTIVE PROCEDURES TO ADDRESS WEIGHT RECIDIVISM AFTER LSG IN A COHORT OF INITIALLY SUPER-OBESE DIFFICULT TO TREAT PATIENTS. WEIGHT LOSS, PROCEDURAL TIME, AND COMPLICATION RATES WERE COMPARABLE. GERD SYMPTOMS IMPROVED IN BOTH TREATMENT GROUPS PROVIDING AN ADDITIONAL BENEFIT FOR PATIENTS WITH PERSISTING REFLUX SYMPTOMS AFTER LSG. ANATOMIC AND PHYSIOLOGIC IMPACT IS SUBSTANTIAL FOR BOTH SADI AND OAGB. CONSEQUENT LIFELONG SUPPLEMENTATION OF MICRONUTRIENTS AND LONG-TERM MEDICAL CARE ARE MANDATORY TO PREVENT LONG-TERM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061539 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention