BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7958259 · Received October 11, 2018

    Report

    Report Number
    2210968-2018-76480
    Event Type
    Death
    Date Received
    October 11, 2018
    Report Date
    September 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON SUTURE CAUSED/ CONTRIBUTED TO THE DEATH? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING ? CITATION: AJNR AM J NEURORADIO/15:263-271, FEB 1994.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON SUTURE CAUSED/ CONTRIBUTED TO THE DEATH? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING ? RESPONSE RECEIVED FROM SURGEON: THE PAPER CONCERNS THE OFF-LABEL USE OF SUTURE AS AN AGENT TO ENDOVASCULARLY OCCLUDE AVM VESSELS PRIOR TO THE SURGICAL EXCISION OF THE AVM. THIS AGENT IS NO LONGER USED FOR THIS PURPOSE DUE THE PROBLEMS STATED IN THE PAPER AND BECAUSE MUCH BETTER AGENTS ARE NOW AVAILABLE, INCLUDING J&J ¿ S OWN PRODUCT TRUFILL NBCA

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: A CLINICAL AND NEUROPATHOLOGIC STUDY OF SILK SUTURE AS AN EMBOLIC AGENT FOR BRAIN ARTERIOVENOUS MALFORMATIONS" AUTHOR(S): JOHN P. DEVEIKIS, HERBERT J . MANZ, ALFRED J. LUESSENHOP, ANTHONY J. CAPUTY, ARTHUR I. KOBRINE, DIETER SCHELLINGER, AND NICHOLAS PATRONAS. CITATION: AJNR AM J NEURORADIO/15:263-271, FEB 1994. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF SILK SUTURE AS AN AGENT FOR PREOPERATIVE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS. A TOTAL OF SIX PATIENTS UNDERWENT TRANSVASCULAR EMBOLIZATION USING SILK SUTURE. FIVE- TO 15 MM OF 5-0 SILK SUTURE (ETHICON) WERE USED IN THESE PATIENTS. IN CASE 1, A 44-YEAR-OLD MALE PATIENT WITH ARTERIOVENOUS MALFORMATION LOCATED IN THE LEFT SYLVIAN FISSURE UNDERWENT PREOPERATIVE EMBOLIZATION OF MIDDLE CEREBRAL FEEDERS WITH 4CM OF 4-0 SILK, 10ML OF THROMBOTIC MIXTURE OF COLLAGEN, ETHYL ALCOHOL (ETH) AND POLYVINYL ALCOHOL MICROPARTICLES (PVA) WERE INJECTED. POSTOPERATIVE COURSE WAS UNEVENTFUL, HOWEVER, HISTOPATHOLOGY SHOWED ACUTE INFLAMMATORY CELL ACCUMULATIONS, EXTRAVASCULAR INFLAMMATION AND PROMINENT VESSEL WALL NECROSIS. IN CASE 3, A 60-YEAR-OLD MALE PATIENT WITH A LARGE ARTERIOVENOUS MALFORMATION IN THE LEFT SYLVIAN FISSURE UNDERWENT EMBOLIZATION OF THE ARTERIOVENOUS MALFORMATION WITH SILK AND SILICONE SPHERES. AFTER EMBOLIZATION, THE PATIENT HAD HEADACHE AND WAS AFEBRILE. SEVEN DAYS AFTER EMBOLIZATION, HEADACHE WORSEN AND HE BECAME UNRESPONSIVE. CT SHOWED LARGE INTRACEREBRAL HEMORRHAGE, BUT THE FAMILY OF THE PATIENT REFUSED SURGERY AND HE WAS TREATED SUPPORTIVELY WITH SOME RECOVERY. THE PATIENT CONTINUED TO BE APHASIC AND HEMIPLEGIC. IN CASE 5, A 49-YEAR-OLD MALE PATIENT WITH LEFT PARIETAL ARTERIOVENOUS MALFORMATION UNDERWENT EMBOLIZATION OF SEVERAL MIDDLE CEREBRAL FEEDERS USING 5-0 SILK FOLLOWED BY THE COLLAGEN-ETHANOL-POLYVINYL ALCOHOL MIXTURE AT TWO SITTINGS. IMMEDIATELY AFTER THE SECOND PROCEDURE, HE COMPLAINED OF NAUSEA, WAS RAPIDLY LAPSE INTO COMA AND CT SHOWED LEFT INTRACEREBRAL HEMORRHAGE. THE HEMATOMA WAS SURGICALLY EVACUATED, BUT PATIENT CONTINUED TO DETERIORATE AND DIED 10 DAYS LATER. RESIDUAL ARTERIOVENOUS MALFORMATION CONTAINED SILK AND OTHER EMBOLIC AGENTS, AS WELL AS LEUKOCYTE ACCUMULATIONS. MODERATE INTRAVASCULAR AND EXTRAVASCULAR INFLAMMATION WAS SEEN AT HISTOPATHOLOGY. IN CASE 6, A 23-YEAR-OLD FEMALE PATIENT WITH LEFT PARACENTRAL ARTERIOVENOUS MALFORMATION UNDERWENT STAGED PREOPERATIVE EMBOLIZATION AT TWO SITTINGS WAS PERFORMED USING SILK AND POLYVINYL ALCOHOL MICROPARTICLES TO OBLITERATE THE MIDDLE CEREBRAL SUPPLY. AFTER THE FIRST STAGE, SHE EXPERIENCED HEADACHE AND LOW GRADE FEVER. AFTER THE SECOND STAGE, SHE HAD FURTHER HEADACHE, LOW-GRADE FEVER AND DIAPHORESIS. MICROSCOPIC ANALYSIS OF THE EXCISED SURGICAL SPECIMEN REVEALED RATHER STRIKING INTRAVASCULAR AND EXTRAVASCULAR INFLAMMATORY CELL INFILTRATION ALONG WITH THE SILK. THE CURRENT STUDY SUGGESTS FOUR CHARACTERISTICS OF SILK SUTURE THAT, AT LEAST THEORETICALLY, MIGHT PREDISPOSE TO BLEEDING. THESE ARE: THE HIGH PRESSURE REQUIRED FOR DELIVERY OF THE EMBOLI; THE POSSIBLE UNCONTROLLED DEPOSITION EITHER IN THE FEEDING ARTERY OR, IF A FISTULA IS PRESENT OR IF FRAGMENTATION OCCURS, IN THE VENOUS DRAINAGE; THE INFLAMMATORY RESPONSE; AND THE MECHANISM OF VESSEL OCCLUSION, IN WHICH A SMALL SILK FIBER IS ASSOCIATED WITH THROMBUS, WHICH CAN RESORB AND RESTORE FLOW TO POSSIBLY NECROTIC VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799192 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death