BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 3181468 · Received June 21, 2013

    Report

    Report Number
    2032282-2013-00061
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CASE 1 IS REGARDING BAXTER'S FLOSEAL. CASE 2 IS REGARDING ETHICON JOHNSON & JOHNSON'S SURGIFLO AND AS SUCH THE CASE WAS FORWARDED TO JOHNSON & JOHNSON. BAXTER MEDICAL ASSESSMENT: ALLERGIC OR ANAPHYLACTIC REACTIONS TO BOVINE GELATIN ARE EXTREMELY RARE, BUT EXPECTED REACTION PATTERNS TO THE USE OF FLOSEAL. THE CALCULATED INCIDENCE BASED ON THE NUMBER OF EXPOSURES IS (B)(4) OCCURRENCES PER MILLION EXPOSURES (OPM). ACCORDING TO THE STANDARDIZED RISK EVALUATION CRITERIA THIS OPM CORRESPONDS TO A MODERATE OVERALL RISK ((B)(4)); [FLOSEAL CLINICAL EVALUATION REPORT, 2012]. THE EVENT IS RELATED TO THE USE OF FLOSEAL, BASED ON A REASONABLE TEMPORAL RELATIONSHIP OF THE EVENT TO THE PRODUCT APPLICATION AND PROOF OF INCREASED IGE TITERS AGAINST BOVINE GELATIN. THE AUTHORS ACCURATELY PRESENT THE EVALUATION OF THE ROOT CAUSE AND THE CLINICAL RISK MINIMIZATION MEASURES IN THEIR PUBLICATION. ADEQUATE REFERENCES TO THIS RISK ARE MADE IN THE FLOSEAL IFU. ESPECIALLY THE CONTRAINDICATION TO USE FLOSEAL IN PATIENTS SENSITIZED TO BOVINE PROTEINS IS TO BE MENTIONED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. NO TREND WAS IDENTIFIED. PER HAYWARD, ADEQUATE REFERENCES TO THIS RISK ARE MADE IN THE FLOSEAL IFU. THE MANUFACTURING FACILITY DETERMINED NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. AFFILIATE OF JOHNSON AND JOHNSON, ETHICON, HAS BEEN NOTIFIED OF THE SURGIFLO AE CASE WITHIN THE ARTICLE. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A LITERATURE (LUHMANN, SCOTT J. ET AL. "INTRAOPERATIVE ANAPHYLAXIS SECONDARY TO INTRAOSSEOUS GELATIN ADMINISTRATION." J PEDIATR ORTHOP 2013; 33:E58-E60. JULY/AUGUST 2013) ANAPHYLAXIS OCCURRED IN WHICH FLOSEAL WAS USED. THE ABSTRACT OF THE LITERATURE IS PROVIDED BELOW. BACKGROUND: FLOSEAL AND SURGIFLO HEMOSTATIC MATRICES ARE COMMONLY USED IN SURGICAL PROCEDURES TO PROMOTE COAGULATION AND MINIMIZE BLOOD LOSS. THEY ARE COMPOSED OF BOVINE AND PORCINE GELATIN MATRIX, RESPECTIVELY, THAT CAN BE INJECTED INTO PEDICLES TO STOP OSSEOUS BLEEDING DURING PEDICLE SCREW INSERTION. METHODS: THIS REPORT DETAILS 2 PEDIATRIC SPINAL DEFORMITY RECONSTRUCTIVE SURGERY PATIENTS WHO EXPERIENCED INTRAOPERATIVE CARDIOVASCULAR EVENTS AFTER THE INTRAOSSEOUS ADMINISTRATION OF ANIMAL-DERIVED GELATIN. RESULTS: CASE #1 IS A(B)(6) FEMALE WITH (B)(6) IDIOPATHIC SCOLIOSIS WHO WAS UNDERGOING ROUTINE POSTERIOR SPINAL INSTRUMENTATION AND FUSION. DURING PLACEMENT OF THE FOURTH PEDICLE SCREW, THE PATIENT DEVELOPED PROFOUND HYPOTENSION, TACHYCARDIA AND ELEVATED AIRWAY PRESSURES REQUIRING INTRAVENOUS EPINEPHRINE AND PHENYLEPHRINE FOR HEMODYNAMIC SUPPORT. SURGERY WAS ABORTED. POSTOPERATIVE WORK-UP DEMONSTRATED A POSITIVE IMMUNOCAP STUDY FOR BOVINE GELATIN. SURGERY WAS REPEATED 1 WEEK LATER, WITHOUT THE USE OF FLOSEAL AND NO EPISODES OF HEMODYNAMIC INSTABILITY. CASE #2 WAS A (B)(6) FEMALE WITH (B)(6) IDIOPATHIC SCOLIOSIS WHO WAS UNDERGOING A GROWING SPINE CONSTRUCT. AS IN CASE #1, SURGIFLO WAS PLACED INTO 2 PEDICLE TRACTS AFTER WHICH THERE WAS PROFOUND HYPOTENSION, TACHYCARDIA, AND ELEVATED AIRWAY PRESSURES. RESUSCITATIVE EFFORTS INCLUDED INTRAVENOUS ATROPINE AND EPINEPHRINE WITH RESOLUTION. SURGERY WAS ABORTED. SURGERY WAS REPEATED 2 WEEKS LATER, WITHOUT THE USE OF SURGIFLO, WITH NO EPISODES OF HEMODYNAMIC INSTABILITY. CONCLUSIONS: GIVEN THAT THE PATIENT'S SYMPTOMS WERE CLASSIC FOR ANAPHYLAXIS, AND THAT THE TIME OF THE ANAPHYLAXIS IMMEDIATELY FOLLOWED THE ADMINISTRATION OF FLOSEAL AND SURGIFLO WE BELIEVE THAT FLOSEAL AND SURGIFLO WERE THE CAUSE OF THE REACTIONS. THESE ARE THE FIRST KNOWN REPORTED CASES OF INTRAOPERATIVE ANAPHYLAXIS ASSOCIATED WITH FLOSEAL AND SURGIFLO. ON THE BASIS OF OUR EXPERIENCE, IN ORDER TO AVOID INTRAOPERATIVE CARDIOVASCULAR EVENTS, WE OBTAIN PREOPERATIVE IMMUNOCAP TESTING AND ELICITING A THOROUGH PREOPERATIVE HISTORY ABOUT BOVINE-DERIVED AND PORCINE-DERIVED GELATIN PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283513 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR