BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT T DETACHABLE COIL SYSTEM

    MDR report key: 6689940 · Received July 6, 2017

    Report

    Report Number
    9616099-2017-00001
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    January 1, 2009
    Report Date
    June 16, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 9616099-2017-00001. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. UDI UNAVAILABLE, LOT UNKNOWN. EXPIRATION DATE UNAVAILABLE, LOT UNKNOWN. MANUFACTURING DATE UNAVAILABLE, LOT UNKNOWN. THERE ARE NO ALLEGED QUALITY ISSUES WITH THE PRODUCT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NO DEVICE RETURNED COIL HERNIATION AND ANEURYSM RECANALISATION ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE CODMAN EMBOLIC COIL DEVICES AND ARE LISTED IN THE IFU. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET SITE/ PARENT VESSEL ANATOMY AND COIL PACKING DENSITY AS WELL AS UNDERLYING DISEASE PROGRESSION MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿EARLY REBLEEDING OF SMALL ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH PRESUMED EXTRUSION OF COIL LOOP TO OUTSIDE THE ANEURYSMAL WALL DURING ENDOVASCULAR TREATMENT¿ BY HW PYUN, DK HYUN, DH LEE, SW PARK, MK LIM, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 15: 103-108, 2009, IT WAS REPORTED THAT THE DISTAL PART OF THE COIL HERNIATED OUT OF THE ANEURYSM AND POST-PROCEDURE ANEURYSM RECANALIZATION WAS REPORTED. PER THE ARTICLE; ¿A (B)(6) WOMAN PRESENTED WITH SEVERE HEADACHE, FOLLOWED BY DETERIORATION OF MENTAL STATUS (HUNT AND HESS GRADE III). BRAIN CT SHOWED PROFUSE SUBARACHNOID HEMORRHAGE (SAH) AND INTRAVENTRICULAR HEMORRHAGE (IVH) AND ADDITIONAL CT ANGIOGRAPHY DEMONSTRATED AN OVAL SHAPED, SMALL ACOMA ANEURYSM, WHICH WAS 2.7 MM IN HEIGHT AND 2.0 MM IN WIDTH. ITS NECK DIAMETER WAS ABOUT 1.8 MM. SHE SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION OF THE ANEURYSM. BECAUSE OF THE UNFAVORABLE ARCHITECTURE OF THE ANEURYSM, IT TOOK MANY TRIALS TO INSERT THE FIRST COIL (2 MM IN DIAMETER, 15 MM IN LENGTH) (TRUFILL MINICOMPLEX 10, CORDIS, JOHNSON AND JOHNSON, MIAMI, FL). DURING AN ATTEMPT AT THE SECOND COIL INSERTION, IT WAS DETECTED THE FIRST LOOP OF A PREVIOUSLY INSERTED COIL WAS BEYOND THE ANEURYSMAL MARGIN. IMMEDIATE ANGIOGRAPHY DID NOT SHOW ANY CONTRAST MEDIA LEAKAGE. ADDITIONAL DELAYED ANGIOGRAPHY DEPICTED NO FURTHER CONTRAST FILLING OF THE SAC SUGGESTING THE POSSIBILITY OF COMBINED INTRA-ANEURYSMAL THROMBOSIS. POST-PROCEDURAL CT SCAN DID NOT SHOW EXTRAVASATION OF CONTRAST OR INCREASED SAH. IT WAS PRESUMED PENETRATED DISTAL COIL LOOP WAS PROTECTED BY INTRAANEURYSMAL THROMBUS FORMATION AT THAT MOMENT. SHE WAS HOSPITALIZED FOR TWO WEEKS UNEVENTFULLY AND DISCHARGED WITH MINIMAL NEUROLOGICAL DEFICIT. FOUR WEEKS AFTER THE INITIAL TREATMENT, SEVERE HEADACHE AND VOMITING ATTACKED HER AGAIN. BRAIN CT SCAN REVEALED RECURRENT SAH WITH IVH. SLACK COIL MESH INCLUDING DISTAL PORTION OF COIL LOOP WHICH PRESUMED BEYOND ANEURYSMAL SAC INITIALLY WAS DEPICTED WITHIN AN INCREASED INDEX ANEURYSM ON CATHETER ANGIOGRAPHY. ADDITIONAL COIL EMBOLIZATION OF THE RECURRED ANEURYSM WAS PERFORMED AFTER EXTERNAL VENTRICULAR DRAINAGE. THREE COILS WERE INSERTED TO ACHIEVE SATISFACTORY EMBOLIZATION OF THE ANEURYSM WITHOUT ANY DIFFICULTY DURING INITIAL ENDOVASCULAR TREATMENT. SHE UNDERWENT A VENTRICULO- PERITONEAL SHUNT AND WAS DISCHARGED WITH MINOR NEUROLOGIC DEFICIT ONE MONTH AFTER THE SECOND EMBOLIZATION. FOLLOW-UP MR ANGIOGRAPHY OBTAINED ONE AND SIX MONTHS AFTER THE SECOND ENDOVASCULAR TREATMENT SHOWED NO EVIDENCE OF RECANALIZATION. REPORTED THERE WERE NO PRODUCT ISSUES EXPERIENCED WHEN USING THE TRUFILL COIL. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471983 TRUFILL DCS ORBIT T DETACHABLE COIL SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention