BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2592291 · Received May 30, 2012

    Report

    Report Number
    2954761-2012-00018
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: AFTER SPINAL SURGERY (PRONE POSITION) IN WHICH FLOSEAL HAS BEEN USED A PATIENT EXPERIENCED DYSPNEA POSTOPERATIVELY. AFTER POSITIVE D-DYMER TEST ON POD4 A THORACIC CT-SCAN REVEALED BILATERAL PULMONARY EMBOLISM THAT HAS SUBSIDED ONE WEEK LATER AFTER LOW MOLECULAR HEPARIN. PATIENT HAS BEEN DISCHARGED ON MARCUMAR. WHILE A TEMPORAL RELATIONSHIP IS NOT OBVIOUS (NO CLEAR INTRAOPERATIVE EVENT), AND TAKING INTO ACCOUNT OTHER ALTERNATIVE CAUSES THAT MAY INDUCE POSTOPERATIVE EMBOLISM, A CAUSAL RELATIONSHIP WITH THE APPLICATION OF FLOSEAL CANNOT BE FULLY EXCLUDED. THE EVENT IS POSSIBLY RELATED TO THE USE OF FLOSEAL. (B)(6). THE COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED BY BAXTER (B)(4) ON (B)(4) 2012: FEMALE PATIENT HAD APPROX. (B)(6) WEIGHT. THIS CAUSED AN INCREASED PRESSURE ON THE VENA CAVA WHEN LYING IN PRONE POSITION. THE PRESSURE WAS ALSO VISIBLE IN PLUMP EPIDURAL VEINS. THE SPINE WAS STABILIZED ON 2 LEVELS. MASSIVE BLEEDINGS IN THE VENOUS AREA OCCURRED, WHICH WERE NOT STOPPABLE BY COAGULATION AND COMPRESSION. THEREFORE 2 UNITS OF FLOSEAL WERE USED. HEMOSTASIS WAS SUCCESSFUL AND THE SURGICAL INTERVENTION WAS PROCEEDED (STANDARD PROCEDURE) WITHOUT ANY SPECIAL OCCURRENCES (NEUROSURGICAL OR ANESTHESIOLOGICAL). POST-OP. SURVEILLANCE WITH I.V. MORPHINE-PAIN TREATMENT (STANDARD SCHEME). (B)(6) DAYS AFTER POST-OP. TAG DIFFICULTIES TO BREATH APPEARED, CT-BEFUND WAS DONE, WHICH SHOWED LARGE DISSEMINATED LUNG EMBOLISM (AS ALREADY REPORTED). BAXTER FINAL MEDICAL ASSESSMENT: THE ADDITIONAL RECEIVED INFORMATION DOES REVEAL AN INCREASED PERIPHERAL VENOUS PRESSURE (PVP) DUE TO CAVA COMPRESSION IN AN EXTREMELY OBESE PATIENT. AS OPPOSED TO THE SITUATION OF A NEGATIVE PVP, THIS SITUATION REDUCES THE RISK OF INTRAVASCULAR PENETRATION OF FLOSEAL. THIS IS WHY A FLOSEAL EMBOLISM APPEARS UNLIKELY. IN ADDITION TO THAT THE TEMPORAL RELATIONSHIP FROM THE APPLICATION OF FLOSEAL (WITH BLEEDING CONTROL AND NO REMARKABLE ANESTHESIOLOGICAL INCIDENTS INTRAOPERATIVELY) TO THE OCCURRENCE OF PULMONARY EMBOLISM SYMPTOMS IS UNREASONABLY LONG. GIVEN THE CO-MORBIDITIES (EXTREME OBESITY, BED IMMOBILIZATION) THE PATIENT HAD A CONSIDERABLY HIGHER RISK OF POSTOPERATIVE THROMBOEMBOLISM. A CAUSAL RELATIONSHIP OF THE INTRAOPERATIVE USE OF FLOSEAL WITH THE PULMONARY EMBOLISM OCCURRING ON POD 4 IS UNLIKELY. EVENT DEEMED NOT RELATED TO THE USE OF FLOSEAL.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT HAD ON (B)(6) 2012 A SPINAL SURGERY (IN PRONE POSITION), WHERE FLOSEAL WAS USED. THE PATIENT EXPERIENCED POSTSURGICAL DYSPNEA AND AN INCREASED D-DYMER. ON (B)(6) 2012 A CT WAS MADE, WHICH SHOWED A PULMONIC EMBOLISM ON BOTH SIDES (BIG AREAS CONCERNED). ON (B)(6) 2012 ANOTHER CT WAS MADE, WHICH SHOWED NO EMBOLISM. THE PATIENT WAS GIVEN 2 TIMES 80MG LOVENOX AND LATER WAS TRANSFERRED TO MARCUMAR. THE PATIENT WAS ABLE TO LEAVE THE HOSPITAL ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD HA111136

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other