BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12705880 · Received October 27, 2021

    Report

    Report Number
    2210968-2021-10439
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    December 22, 2020
    Report Date
    October 27, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2021; 50: 798¿800 HTTPS://DOI.ORG/10.1016/J.IJOM.2020.11.019,

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: PSEUDOANEURYSM IN THE INFERIOR ALVEOLAR ARTERY FOLLOWING A BAD SPLIT IN BILATERAL SAGITTAL SPLIT OSTEOTOMY AUTHOR: A. ABUKARAKY1, M. AL MOUSA1, O. A. SAMARA2, Z. H. BAQAIN1,3 CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2021; 50: 798¿800 HTTPS://DOI.ORG/10.1016/J.IJOM.2020.11.019, THIS STUDY PRESENTS AN UNUSUAL CASE OF INFERIOR ALVEOLAR ARTERY (IAA) PSEUDOANEURYSM AFTER BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO) THAT WAS COMPLICATED WITH A BAD SPLIT IS REPORTED HERE. A CASE OF A A (B)(6) YEAR-OLD FEMALE PATIENT REFERRED FOR LE FORT I OSTEOTOMY AND BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO) SETBACK.PREOPERATIVE HAEMOGLOBIN WAS 14.1 G/DL. THE MAXILLARY OSTEOTOMY WAS UNEVENTFUL, HOWEVER DURING THE BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO) A BAD SPLIT OCCURRED ON THE RIGHT SIDE, WITH BUCCAL PLATE FRACTURE AND A FRACTURE LINE EXTENDING POSTERIORLY TO THE SIGMOID NOTCH INCLUDING THE CONDYLAR NECK. OSTEOTOMES WERE USED TO COMPLETE THE DISTAL SEGMENT SEPARATION FROM THE PROXIMAL SEGMENT. PULSATILE BLEEDING ENSUED FROM THE MEDIAL SIDE OF THE RAMUS, WHICH WAS CONTROLLED WITH DIRECT PRESSURE USING A GAUZE AND ABSORBABLE HAEMOSTATIC AGENT (SURGICEL, ETHICON).WITH THE FINAL OCCLUSION ESTABLISHED, FIXATION WAS ACHIEVED. THE VALSALVA MANOEUVRE CONFIRMED HAEMOSTASIS AND THE ESTIMATED BLOOD LOSS WAS 900 ML. THE PATIENT MADE AN UNEVENTFUL RECOVERY AND POSTOPERATIVE HAEMOGLOBIN WAS9.1 G/DL. SHE WAS DISCHARGED ON DAY 3 POSTOPERATIVE WITH MORE SWELLING NOTED ON THE RIGHT SIDE. ON DAY 18 POSTOPERATIVE, THE PATIENT ATTENDED AS AN EMERGENCY DUE TO RECURRING BLEEDING EPISODES AND RECURRING THROBBING PAIN ON THE SAME SIDE OF THE THROAT. SHE WAS CONSCIOUS, HYPOTENSIVE (70/40 MMHG), AND TACHYCARDIC (130 BPM) AND HER HAEMOGLOBIN WAS 7.2 MG/DL. SHE WAS ADMITTED AND TRANSFUSED WITH ONE UNIT OF PACKED RED BLOOD CELLS. A CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SCAN GAVE THE IMPRESSION OF BLEEDING FROM THE MAXILLARY ARTERY OR IAA.DECISION WAS MADE TO PROCEED WITH ANGIOGRAPHY, WITH POSSIBLE SELECTIVE EMBOLIZATION OF THE BLEEDING VESSEL. MULTIPLE IMAGES SHOWED A LARGE PSEUDOANEURYSM THAT WAS ACTIVELY BLEEDING, WITH CONTRAST. SELECTIVE CATHETERIZATION OF THE OSTIUM OF THE INFERIOR ALVEOLAR ARTERY (IAA) INTO THE PSEUDOANEURYSM WAS ATTEMPTED SUCCESSFULLY. TWO MORE UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED, AND THE PATIENT WAS DISCHARGED FROM HOSPITAL AFTER 2 DAYS. SHE REMAINED WELL 6 MONTHS AFTER SURGERY. IT WAS CONCLUDED, THAT THE AGGRESSIVE MANIPULATION IN THE MANDIBLE POSTERIORLY TOWARDS THE CONDYLE WITH OSTEOTOMES TO ACHIEVE A SPLIT SHOULD BE AVOIDED. IF ASSOCIATED WITH BOUTS OF POSTOPERATIVE BLEEDING, THE SURGICAL TEAM SHOULD SEEK ADVANCED RADIOLOGICAL INVESTIGATIONS TO CONFIRM A POTENTIAL PSEUDOANEURYSM. ONCE THE PATIENT IS HAEMODYNAMICALLY STABILIZED, A CTASSISTED ANGIOGRAPHY IS USEFUL TO LOCATE AND EMBOLIZE THE BLEEDING VESSEL. THE USE OF TRANS-CATHETER INTERVENTION HAS IMPROVED ACCESS TO SURGICALLY INACCESSIBLE VESSELS AND REDUCED THE MORBIDITY ASSOCIATED WITH OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602165 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention