BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 20522633 · Received October 24, 2024

    Report

    Report Number
    2210968-2024-11056
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    March 16, 2021
    Report Date
    October 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; 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: BRITISH JOURNAL OF NEUROSURGERY, DOI: 10.1080/02688697.2021.1905771. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: ENDOSCOPIC TRANSSPHENOIDAL SURGERY RECONSTRUCTION USING THE FIBRIN SEALANT PATCH TACHOSIL®. AUTHOR(S): KARAN JOLLY, KESHAV KUMAR GUPTA, OFUCHI EGBUJI, PARESH PRAMOD NAIK & SHAHZADA KHURAM AHMED. CITATION: BRITISH JOURNAL OF NEUROSURGERY, DOI: 10.1080/02688697.2021.1905771. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TACHOSIL TO REPAIR INTRAOPERATIVE DEFECTS DURING AN ENDOSCOPIC TRANSSPHENOIDAL APPROACH. BETWEEN JANUARY 2013 AND JUNE 2020, 51 PATIENTS (52 PROCEDURES) WHO UNDERWENT AN ENDOSCOPIC TRANSSPHENOIDAL APPROACH WITH THE USE OF TACHOSIL AS THE OVERLAY WERE INCLUDED IN THE STUDY. THERE WERE 21 MALES AND 30 FEMALES WITH A MEAN AGE OF 44 ± 16.1 YEARS (RANGE, 18¿83) AND A MEAN BMI OF 29.6 ± 7.5 KG/M2 (RANGE, 18.3¿59.6). A LIMITED POSTERIOR SEPTECTOMY WAS PERFORMED AND A WIDE SPHENOIDOTOMY WAS MADE USING A COMBINATION OF KERISONS RONGEURS AND A HIGH-SPEED DIAMOND BURR DRILL. AFTER THE PRIMARY PATHOLOGY WAS ADDRESSED, THE REPAIR TECHNIQUE VARIED DEPENDING ON THE PRECISE SITE AND SIZE OF THE DEFECT AS WELL AS THE CEREBROSPINAL FLUID LEAK FLOW RATE. ONE LAYER OF SURGICEL (OXIDIZED CELLULOSE, ETHICON INC) WAS PLACED WITHIN THE SELLA DEFECT AND, IN THE PRESENCE OF A CEREBROSPINAL FLUID LEAK, A COMPETITOR EXTRADURAL DURAL GRAFT (DURAGEN, MANUFACTURER: INTEGRA LIFE SCIENCES) WAS PLACED UNDER THE BONY EDGES OF THE SELLOTOMY DEFECT. A COMPETITOR FIBRIN SEALANT PATCH (TACHOSIL, MANUFACTURER: TAKEDAPHARMA) WAS THEN PLACED OVER THE BONY EDGES OF THE DEFECT, PREVIOUSLY DENUDED OF MUCOSA. THE RECONSTRUCTION WAS THEN TESTED WITH A VALSALVA MANOEUVRE AND THEN HELD IN PLACE WITH FURTHER LAYERS OF SURGICEL AND TISSUE GLUE (EVICEL FIBRIN SEALANT, JOHNSON & JOHNSON MEDICAL DEVICES). THE NASAL CAVITY WAS THEN PACKED WITH A COMPETITOR ABSORBABLE NASOPORE (MANUFACTURER: STRYKER). REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE CEREBROSPINAL FLUID LEAK (N=4). IN CONCLUSION, WE BELIEVE THIS TO BE THE LARGEST CASE SERIES EVALUATING THE ENDOSCOPIC USE OF TACHOSIL IN SKULL BASE RECONSTRUCTION. OUR DATA SHOW THAT IN ENDOSCOPIC TRANSSPHENOIDAL APPROACH, TACHOSIL MAY BE USED SAFELY IN A MULTI-LAYERED APPROACH AS AN EFFECTIVE ALTERNATIVE TO THE NASOSEPTAL FLAP IN LOW FLOW CEREBROSPINAL FLUID LEAK CASES, OR ALONGSIDE A NASOSEPTAL FLAP IN HIGHER FLOW LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737469 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other