BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7418026 · Received April 10, 2018

    Report

    Report Number
    2210968-2018-72071
    Event Type
    Injury
    Date Received
    April 10, 2018
    Report Date
    March 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: J THORAC CARDIOVASC SURG. 1999; 118: 1078 83. (B)(4)]

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PHARYNGEAL REFLUX AFTER GASTRIC PULL-UP ESOPHAGECTOMY WITH NECK AND CHEST ANASTOMOSES" AUTHORS: JAN JOHANSSON, MD, FOLKE JOHNSSON, MD, PHD, SUSAN GROSHEN, PHD, BRUNO WALTHER, MD, PHD CITATION: J THORAC CARDIOVASC SURG. 1999; 118: 1078 83. PHARYNGEAL REFLUX AFTER A GASTRIC PULL-UP ESOPHAGECTOMY MAY CAUSE ASPIRATION. THE STUDY EVALUATES ACID EXPOSURE TO THE ESOPHAGEAL REMNANT AND TO THE PHARYNX AFTER GASTRIC PULL-UP ESOPHAGECTOMY AND EVALUATES THE IMPACT OF ADDITIONAL DISSECTION OF THE ESOPHAGUS THAT IS NECESSARY FOR NECK ANASTOMOSES VERSUS NO NECK EXPLORATION AND PROXIMAL CHEST ANASTOMOSES. A TOTAL OF 47 PATIENTS (35 MALE AND 12 FEMALE) UNDERWENT ESOPHAGECTOMY AND A GASTRIC PULL-UP AND WERE INCLUDED IN THE STUDY. OF WHICH, 27 PATIENTS UNDERWENT CIRCULAR STAPLED ANASTOMOSES IN THE APEX OF THE RIGHT CHEST AND 20 PATIENTS UNDERWENT MANUAL SUTURED NECK ANASTOMOSES. IN THE CIRCULAR STAPLED ANASTOMOSES, THE GASTRIC TUBE WAS CREATED WITH THE AID OF A TLC 55 LINEAR STAPLING DEVICE OR GASTROINTESTINAL ANASTOMOSIS. THE DEVICE WAS INSERTED INTO THE LESSER CURVATURE APPROXIMATELY 7 CM PROXIMAL TO THE PYLORUS AND FIRED MULTIPLY, CREATING A 5-CM WIDE TUBE ALONG THE GREATER CURVATURE OF THE STOMACH. A 90-MM RL LINEAR STAPLING DEVICE WAS USED TO RESECT THE GASTRIC REMNANT, INCLUDING THE OPENING FROM THE PREVIOUSLY INSERTED CIRCULAR STAPLING DEVICE. WHEN THE STAPLED THORACIC ANASTOMOSIS WAS CREATED, THE LARGEST POSSIBLE CARTRIDGE WAS INSERTED. IN THE END-TO-END ANASTOMOSES OF THE NECK, THE AUTHORS MANUALLY SUTURED THE REMAINING CERVICAL ESOPHAGUS WITH A PDS II 4-0 SUTURE WITH A CONTINUOUS SINGLE LAYER TECHNIQUE THROUGH ALL THE LAYERS. IN THE CHEST ANASTOMOSES GROUP, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STRICTURE (3 MONTHS [N-5]; 12 MONTHS [N-1]) WHICH REQUIRED DILATATION THERAPY AND ESOPHAGITIS (3 MONTHS [N-7]; 12 MONTHS [N-1]). IN THE NECK ANASTOMOSES GROUP, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STRICTURE (3 MONTHS [N-3]) AND ESOPHAGITIS (3 MONTHS [N-2]; 6 MONTHS [N-1]). IT WAS CONCLUDED THAT THE ACID EXPOSURE TO THE ESOPHAGEAL REMNANT AND TO THE PHARYNX INCREASED DURING THE FIRST POST-OPERATIVE YEAR IN PATIENTS WITH NECK ANASTOMOSES BUT NOT IN PATIENTS WITH PROXIMAL CHEST ANASTOMOSES. THE RESULTS SUGGEST A LESS FAVORABLE ACID CLEARANCE IN PATIENTS WITH THE NECK APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254014 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention