BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12419073 · Received September 2, 2021

    Report

    Report Number
    2210968-2021-08017
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    October 24, 2019
    Report Date
    August 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2020) 68:1208¿1211\.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: TOTAL PLEURAL COVERAGE FOLLOWED BY LUNG TRANSPLANTATION IN PATIENT WITH LYMPHANGIOLEIOMYOMATOSIS. AUTHOR/S: DO HYUNG KIM· HYO YEONG AHN· BONG SOO SON· JOOHYUNG SON. CITATION: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2020) 68:1208¿1211. HTTPS://DOI.ORG/10.1007/S11748-019-01217-0. THIS STUDY AIMS TO REPORT THE CASE OF A (B)(6) YEAR-OLD FEMALE WITH A SECONDARY SPONTANEOUS PNEUMOTHORAX CAUSED BY TSC-LAM WHO UNDERWENT TPC PRIOR TO LUNG TRANSPLANTATION. A (B)(6) YEAR-OLD FEMALE WAS ADMITTED TO THE EMERGENCY ROOM WITH DYSPNEA, AND RIGHT PNEUMOTHORAX WAS DIAGNOSED. CHEST COMPUTED TOMOGRAPHY (CT) REVEALED THE FEATURES OF LYMPHANGIOLEIOMYOMATOSIS (LAM), INCLUDING FACIAL ANGIOFIBROMA, HYPOMELANOTIC MACULES, AND RENAL ANGIOMYOLIPOMA; WE THUS DIAGNOSED TUBEROUS SCLEROSIS COMPLEX (TSC)-LAM. AS THE AIR LEAKAGE HAD DEVELOPED 10 DAYS PRIOR, AIRLEAK CONTROL WAS PERFORMED BY VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), WHICH SHOWED MULTIPLE LUNG CYSTS WITH RUPTURED BULLAE SURROUNDED BY A DENSE ADHESION IN THE RIGHT UPPER LOBE. AFTER RELEASING THE ADHESION, THE BULLAE WAS LIGATED, AND COVERED A HUGE FRAGILE CYST AT RISK OF IMMINENT RUPTURE WITH AN ABSORBABLE POLYGLYCOLIC ACID SHEET (NEOVEIL; GUNZE LTD., KYOTO, JAPAN) AND FIBRIN SEALANT (TISSEEL; BAXTER HEALTHCARE CORP., DEERFIELD, IL, USA). TO PREVENT RECURRENCE, WE PERFORMED TOTAL PLEURAL COVERAGE (TPC) OF THE ENTIRE LUNG SURFACE USING 12 SHEETS OF OXIDIZED REGENERATED CELLULOSE (ORC) MESH (ETHICON SURGICEL ® ABSORBABLE HEMOSTAT GAUZE, JOHNSON & JOHNSON, BRUNSWICK, NJ, USA). THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 9. ONE MONTH LATER, SHE WAS READMITTED TO TREAT A CONTRALATERAL RECURRENT PNEUMOTHORAX. SHE AGAIN UNDERWENT TPC AFTER LIGATION OF THE RUPTURED BULLAE AND WAS DISCHARGED ON POD 22. HOME OXYGEN THERAPY AND SIROLIMUS 1 MG DAILY WAS PRESCRIBED, BECAUSE THE DYSPNEA REMAINED AGGRAVATED EVEN AFTER OPERATION. FOURTEEN MONTHS LATER, LUNG TRANSPLANTATION WAS SUCCESSFULLY PERFORMED; BOTH LUNGS THAT HAD BEEN SUBJECTED TO TPC WERE SAMPLED, REVEALING THICKENED VISCERAL PLEURA SURROUNDED BY MINIMAL INFLAMMATION. AFTER THE OPERATION, OXYGEN THERAPY WAS NO LONGER NECESSARY AND SHE WAS DISCHARGED ON POD 41 WITHOUT ANY COMPLICATION. REPORTED COMPLICATIONS INCLUDED CONTRALATERAL RECURRENT PNEUMOTHORAX. IN CONCLUSION, TSC-LAM IS A RARE DISEASE, WHICH MAY TRIGGER AN INTRACTABLE PNEUMOTHORAX. TPC MIGHT BE ONE OF THE GOOD TOOLS FOR PREVENTION OF RECURRED PNEUMOTHORAX, MAKING THE THICKENED VISCERAL PLEURA USEFUL TO DESCRIBE OUR PATIENT WITH LAM WHO UNDERWENT TPC FOLLOWED BY LUNG TRANSPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316247 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention