BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 8350442 · Received February 19, 2019

    Report

    Report Number
    2647580-2019-00904
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    November 30, 2018
    Report Date
    February 19, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: INCARCERATED PARAESOPHAGEAL HERNIA COMPLICATED BY PANCREATIC DAMAGE AND USUAL COMORBIDITY: TWO RETROSPECTIVE CASE SERIES SOURCE: THE AUTHORS. PUBLISHED BY ELSEVIER LTD ON BEHALF OF IJS PUBLISHING GROUP LTD. INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 54 (2019) 75¿78 H6. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE, AFTER INCARCERATED PARAESOPHAGEAL HERNIA (PEH), COMPLICATION CASE WAS REPORTED. THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER ADMISSION DUE TO FOUR DAYS OF VOMITING AND EPIGASTRIC PAIN. CT SCAN REVEALED A LARGE PEH. BECAUSE OF ISCHEMIC DAMAGE TO LARGE PARTS OF THE STOMACH A LAPAROSCOPIC GASTRECTOMY WITH ROUX-EN-Y RECONSTRUCTION WAS PERFORMED USING A DEVICE TO CONSTRUCT A CIRCULAR STAPLED ANASTOMOSIS. FOUR DAYS AFTER SURGERY A LAPAROTOMY WAS PERFORMED DEMONSTRATING HERNIATION OF THE BILIOPANCREATIC LIMB. AT DAY 17 THE PATIENT HAD FEVER AND VOMITING AND A DEFECT IN THE ESOPHAGOJEJUNOSTOMY WAS CON-FIRMED BY ENDOSCOPY. A SUMP TUBE PLACED THROUGH THE DEFECT WAS HELD ON CONTINUOUS SUCTION FOR FOUR DAYS BEFORE INSERTION OF A PARTIALLY COVERED ENDOFLEX STENT. FOLLOWING ENDOSCOPIC EVALUATION OF THE DEFECT AFTER TWO WEEKS THE TREATMENT WAS CONTINUED WITH AN IDENTICAL STENT. THE PATIENT WAS DISCHARGED HOME DAY 54 AND READMITTED DAY 58. CT DEMONSTRATED GASTROJEJUNAL LEAKAGE, A MEDIASTINAL FLUID COLLECTION AND AN ABSCESS ADJACENT TO THE PANCREATIC TAIL. PERCUTANEOUS ABSCESSOGRAPHY AND DRAINAGE DEMONSTRATED PASSAGE OF CONTRAST THROUGH THE ANASTOMOSIS NO LONGER COVERED BY THE DISTALLY MIGRATED STENT. THERE WAS NEAR TOTAL ANASTOMOTIC DEHISCENCE HE GRADUALLY IMPROVED, AND THE THIRD STENT WAS REMOVED AT DAY 85. A FORTH ENDOFLEX STENT WAS NECESSARY UNTIL DAY 103 FOR COMPLETE HEALING OF THE ANASTOMOSIS. THE PATIENT WAS TRANSFERRED TO THE LOCAL HOSPITAL AT DAY 104, AND AT DISCHARGE ON DAY 134 THE PATIENT WAS ALLOWED INTAKE OF FOOD, BUT STILL RECEIVED NUTRITIONAL SUPPLEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142227 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R