BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2982556 · Received February 25, 2013

    Report

    Report Number
    1220423-2013-00006
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 15, 2013
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE LITERATURE DESCRIPTION. JOURNAL: A JOURNAL OF (B)(6) SURGICAL ASSOCIATION. AUTHOR: YAMANAKA M, MIYACHI M, KURAHASHI S ET AL. TITLE: A CASE OF ESOPHAGEAL HIATAL HERNIA OCCURRED AFTER A SURGERY FOR ESOPHAGEAL CARCINOMA. VOLUME: 73, PAGES: 733. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    EPIGASTRIC PAIN [ABDOMINAL PAIN UPPER]. PERICARDIAL EFFUSION [PERICARDIAL EFFUSION]. CARDIAC FAILURE DUE TO PERICARDIAL EFFUSION [CARDIAC FAILURE]. ESOPHAGEAL HIATAL HERNIA [HIATUS HERNIA]. ADHESION HAD LITTLE AT THE WOUND [POSTOPERATIVE ADHESION]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN. THE REPORT WAS FROM A LITERATURE ARTICLE ENTITLED "A CASE OF ESOPHAGEAL HIATAL HERNIA OCCURRED AFTER A SURGERY FOR ESOPHAGEAL CARCINOMA". THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR ESOPHAGEAL CARCINOMA AND CHEMORADIOTHERAPY. ON AN UNSPECIFIED DATE, THE PATIENT WAS HOSPITALIZED. ON AN UNSPECIFIED DATE IN (B)(6) 2012, SUBTOTAL ESOPHAGECTOMY AND THREE-FIELD DISSECTION WITH RIGHT THORACOTOMY AND LAPAROTOMY AND INTRAPERITONEAL RECONSTRUCTION USING NASOGASTRIC TUBE VIA POSTERIOR MEDIASTINUM WERE IMPLEMENTED. SEGMENTECTOMY OF THE RIGHT AND LEFT CRUS OF DIAPHRAGM AND RADICAL DISSECTION FROM ABDOMINAL AREA TO LOWER MEDIASTINUM WERE PERFORMED, AND A PART OF THE LEFT PLEURA WAS RESECTED. WHEN CLOSING ABDOMEN, ESOPHAGEAL HIATUS WAS COATED WITH ELEVATED GREATER OMENTUM, AND SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) WAS PLACED TO THE DORSAL SURFACE OF EXTRAHEPATIC LATERAL SEGMENTAL AREA AND UNDER THE SURGICAL WOUND (NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER OF SEPRAFILM WAS NOT PROVIDED. ON UNSPECIFIED DATES IN 2012, THE PATIENT DEVELOPED THE EVENT OF PERICARDIAL EFFUSION AND CARDIAC FAILURE AFTER THE SURGERY. THE COMPANY ASSESSED THE EVENT OF PERICARDIAL EFFUSION AND CARDIAC FAILURE DUE TO PERICARDIAL EFFUSION AS MEDICALLY SIGNIFICANT. ON THE POSTOPERATIVE DAY 36, THE EVENT OF CARDIAC FAILURE DUE TO PERICARDIAL EFFUSION ALLEVIATED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON THE POSTOPERATIVE DAY 62, THE PATIENT VISITED THE HOSPITAL DUE TO EPIGASTRIC PAIN. ON AN UNSPECIFIED DATE IN 2012, THE CHEST X-RAY AND COMPUTED TOMOGRAPHY (CT) SCAN WERE PERFORMED AND THEY DEMONSTRATED SMALL INTESTINE INVAGINATED FROM ESOPHAGEAL HIATAL HERNIA). IT WAS REPORTED THAT ADHESION HAD LITTLE AT THE WOUND AND ESOPHAGEAL HIATUS AREA. APPROXIMATELY 200 CM OF JEJUNUM INVAGINATED FROM ESOPHAGEAL HIATUS INTO THORACIC CAVITY AND WAS STRANGULATED. AFTER REINTEGRATION, REEFING OF ESOPHAGEAL HIATUS WAS PERFORMED TRYING NOT TO DAMAGE THE BLOOD FLOW OF NASOGASTRIC TUBE AND ABDOMEN WAS CLOSED AS THE COLOR OF SMALL INTESTINE WAS IMPROVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE POSTOPERATIVE DAY 07. THE EVENTS OF EPIGASTRIC PAIN AND ESOPHAGEAL HIATAL HERNIA RECOVERED. THE OUTCOME FOR THE EVENTS OF ADHESION HAD LITTLE AT THE WOUND AND PERICARDIAL EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND ALL THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. IT WAS REPORTED THAT THE REPORTS ON THE CASE HAVE BEEN SEEN OCCASIONALLY, AND THE CAUSE OF SUCH CASES HAS BEEN POINTED OUT AS INSUFFICIENT SUTURE OF DIAPHRAGM. HOWEVER, ACCORDING TO PHYSICIAN IT WAS DIFFICULT TO JUDGE THE APPROPRIATE STATE OF SUTURE FOR ESOPHAGEAL HIATUS TRYING NOT TO DAMAGE THE BLOOD FLOW OF NASOGASTRIC TUBE. IN THIS CASE, THE AREA OF ESOPHAGEAL HIATUS WAS COATED WITH GREATER OMENTUM, AND IT WAS CONSIDERED THAT SMALL INTESTINE INVAGINATED INTO ESOPHAGEAL HIATUS BEYOND TRANSVERSE COLON BECAUSE NEGATIVE PRESSURE OF THORACIC CAVITY CREATED CREVICE AND NO ADHESION OCCURRED AT THE CLOSER SITE OF HIATUS THAT SEPRAFILM WAS APPLIED TO INFERIOR SURFACE OF LIVER. REEFING OF DILATED ESOPHAGEAL HIATUS AND THE MORE REVISED WAY OF APPLICATION OF SEPRAFILM MAY BE REQUIRED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79361 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R