BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7710920 · Received July 23, 2018

    Report

    Report Number
    2210968-2018-74556
    Event Type
    Injury
    Date Received
    July 23, 2018
    Report Date
    July 3, 2018
    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

    (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 REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 USED IN THIS PROCEDURE? CITATION: INTERNATIONAL JOURNAL OF SURGERY. 2017; 48: 210 214. DOI: HTTPS://DOI.ORG/10.1016/J.IJSU.2017.11.001 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: INDOCYANINE GREEN TISSUE ANGIOGRAPHY AFFECTS ANASTOMOTIC LEAKAGE AFTER ESOPHAGECTOMY. A RETROSPECTIVE, CASE-CONTROL STUDY AUTHOR : IOANNIS KARAMPINISA, ULRICH RONELLENFITSCHB, CHRISTINA MERTENSA, ANDREAS GERKENA, SVETLANA HETJENSC, STEFAN POSTA, PETER KIENLEA, KAI NOWAKA CITATION: INTERNATIONAL JOURNAL OF SURGERY. 2017; 48: 210 214. DOI: HTTPS://DOI.ORG/10.1016/J.IJSU.2017.11.001. OPTIMAL PERFUSION OF THE GASTRIC CONDUIT DURING ESOPHAGECTOMY IS ELEMENTARY FOR THE ANASTOMOTIC HEALING SINCE POOR PERFUSION HAS BEEN ASSOCIATED WITH INCREASED MORBIDITY DUE TO ANASTOMOTIC LEAKS. UNTIL RECENTLY, SURGICAL EXPERIENCE WAS THE MAIN TOOL TO ASSESS THE PERFUSION OF THE ANASTOMOSIS. THE AUTHORS HYPOTHESIZED THAT ANASTOMOSES LOCATED IN THE ZONE OF OPTIMAL ICG PERFUSION OF THE GASTRIC CONDUIT (¿OPTIZONE¿) HAVE A REDUCED ANASTOMOTIC LEAKAGE RATE AFTER ESOPHAGECTOMY. A TOTAL OF 88 PATIENTS WITH PRIMARY ESOPHAGEAL CARCINOMA WHO UNDERWENT ESOPHAGECTOMY IN THE DEPARTMENT AND WERE ENROLLED IN THE STUDY. A TOTAL OF 33 PATIENTS (9 FEMALE AND 24 MALE PATIENTS; AGE RANGE: 65.7 ± 8.5; BMI: 26.8 ± 4.2) WERE OPERATED BETWEEN AUGUST 2014 AND DECEMBER 2016 WITH INTRAOPERATIVE ICG FLUORESCENCE ANGIOGRAPHY. THE RESULTS WERE COMPARED TO A CONSECUTIVE COHORT OF 55 PATIENTS (CONTROL GROUP; 14 FEMALE AND 41 MALE PATIENTS; AGE RANGE: 60.5 ± 8.5; BMI: 25.8 ± 4.3) WHO HAD BEEN OPERATED BETWEEN 2010 AND 2014 WITHOUT INTRAOPERATIVE ICG TISSUE ANGIOGRAPHY. DURING THE SURGICAL PROCEDURE IN BOTH GROUPS, A 3- TO 5-CM WIDE GASTRIC CONDUIT WAS CREATED UNDER PRESERVATION OF THE RIGHT GASTRIC (WHEN POSSIBLE) AND GASTROEPIPLOIC ARTERY. LINEAR STAPLERS WERE USED TO PREPARE THE GASTRIC CONDUIT AND THE STAPLE LINES WERE OVERSEWN WITH PDS 4-0 SUTURES. THE TUBULARIZED GASTRIC CONDUIT WAS BROUGHT UP TO THE POSTERIOR MEDIASTINUM AND A CIRCULAR STAPLER (ETHICON) WAS USED FOR THE ANASTOMOSIS. PATIENTS WITH TUMOR OF THE PROXIMAL OR UPPER THORACIC ESOPHAGUS WERE OPERATED THORACOSCOPICALLY IN PRONE POSITION. AFTER PULL-UP OF THE GASTRIC CONDUIT TO THE NECK, A CERVICAL END TO END HAND-SEWN SINGLE LAYER ANASTOMOSIS WAS PERFORMED. IN THE ICG GROUP, REPORTED COMPLICATIONS INCLUDED MALPERFUSION TOWARDS THE TIP OF THE GASTRIC CONDUIT (N-26) WHICH REQUIRED GASTRIC CONDUIT SHORTENING, SEVERELY STRESSED GASTRIC CONDUIT (N-1) WHICH REQUIRED GASTRIC CONDUIT SHORTENING AND AN INTRATHORACIC ANASTOMOSIS IN THE OPTIZONE WAS PERFORMED AND NO LEAK WAS OBSERVED, AND ANASTOMOTIC LEAKAGE (N-1). IN THE CONTROL GROUP, REPORTED COMPLICATIONS INCLUDED MINOR ANASTOMOTIC LEAKAGE (N-6) WITHOUT NEED FOR FURTHER INTERVENTIONAL TREATMENT, MAJOR CLINICAL LEAKAGE WITH A NECROSIS OF THE GASTRIC CONDUIT (N-3), AND ANASTOMOTIC LEAKAGE (N-1). IT WAS REPORTED THAT ADEQUATE PERFUSION IS ESSENTIAL FOR THE UNCOMPLICATED HEALING OF GASTROINTESTINAL ANASTOMOSES. ICG TISSUE ANGIOGRAPHY REPRESENTS A FEASIBLE AND RELIABLE TECHNICAL SUPPORT IN THE EVALUATION OF THE ANASTOMOTIC PERFUSION AFTER ESOPHAGECTOMY. IN THIS RETROSPECTIVE ANALYSIS, THE AUTHORS OBSERVED A SIGNIFICANT DECREASE IN ANASTOMOTIC LEAKAGE RATE WHEN THE ANASTOMOSIS COULD BE PLACED IN THE ZONE OF GOOD PERFUSION DEFINED BY ICG FLUORESCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552486 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CIRCULAR STAPLER