BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4697840 · Received April 16, 2015

    Report

    Report Number
    1058196-2015-00082
    Event Type
    Injury
    Date Received
    April 16, 2015
    Date of Event
    March 21, 2015
    Report Date
    March 23, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: A 7FR SHEATH INTRODUCER BY UNSPECIFIED MANUFACTURER, A CHIKAI (ASAHI INTECC, 0.014¿), TRAXCESS 14 (TERUMO), A ROADMASTER (GOODMAN, 7FR), AN ECHELON 14 (COVIDIEN (B)(4)), A PROWLER SELECT PLUS (45 ANGLE, LOT UNKNOWN), A SCEPTER C4X15 (TERUMO), AND A DCS SYRINGE II (LOT UNKNOWN) WERE USED FOR THIS PROCEDURE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAD NOT YET BEEN COMPLETED. INFORMATION REGARDING PATIENT AGE, WEIGHT AND CONCOMITANT MEDICATIONS WAS NOT PROVIDED. (B)(4). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT VERTEBRAL ARTERY ANEURYSM, AN ENTERPRISE VRD (ENC452212/10358980) MIGRATED FROM THE INTENDED SITE, AND THE PHYSICIAN THOUGHT THE PROXIMAL MARKER OF THE DELIVERY WIRE APPEARED DARKER THAN USUAL IN ANGIOGRAPHY. A PROWLER SELECT PLUS (45 ANGLE, LOT UNKNOWN) WAS FIRST POSITIONED OVER THE DISTAL SIDE OF THE ANEURYSM NECK. THE ECHELON 14 MICROCATHETER WAS THEN INTRODUCED INTO THE ANEURYSM, AND THE SCEPTER BALLOON CATHETER WAS POSITIONED AT THE PROXIMAL RIM OF THE ANEURYSM NECK. THE ENTERPRISE VRD WAS DEPLOYED AFTER HALF OF A COSMOS 18 COIL (TERUMO, 6X19) WAS LOOPED IN THE ANEURYSM. THE COSMOS WAS FULLY DETACHED FOLLOWING THE DEPLOYMENT. THE DELIVERY WIRE WAS THEN KEPT IN THE POSITION TO USE AS THE MARKER FOR GUIDING THE SCEPTER FROM OUTSIDE TO INSIDE OF THE VRD. THE PHYSICIAN THEN WITHDREW BOTH THE DELIVERY WIRE AND THE PROWLER, BUT THE VRD MIGRATED PROXIMALLY. FORTUNATELY THE ANEURYSM NECK WAS STILL COVERED BY THE FLARED PART OF THE GRAFTED VRD TO PREVENT THE COIL MIGRATION. IT WAS REPORTED THAT THE STENT REMAINED GRAFTED IN THE PATIENT TO HOLD THE COILS DESPITE THE MIGRATION. THE PHYSICIAN WAS ABLE TO FULLY EMBOLIZE THE ANEURYSM, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE PHYSICIAN THOUGHT THE PROXIMAL MARKER OF THE DELIVERY WIRE APPEARED FAR DARKER THAN USUAL IN THE ANGIOGRAPHY. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE DEVICE APPEARED NORMAL PRIOR TO USE. THERE WAS NO RESISTANCE WHILE THE ENTERPRISE WAS ADVANCED THROUGH THE PROWLER, AND EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE DURING THE PROCEDURE. THE ENTERPRISE HAD NOT BEEN PREVIOUSLY RE-CAPTURED, AND THE MICROCATHETER HAD NOT BEEN RE-SHAPED PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ONE NON-STERILE ENTERPRISE DELIVERY WIRE AND A TUBE DISPENSER WERE RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE DELIVERY WIRE WAS RECEIVED COILED APART IN A SEPARATED PACKAGE FROM TUBE DISPENSER. TUBE DISPENSER WAS RECEIVED EMPTY. NO OTHERS COMPONENTS FROM THE ENTERPRISE SYSTEM WERE RECEIVED. NEITHER STENT NOR INTRODUCER TUBE WERE RECEIVED. THE DELIVERY WIRE WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES OR DAMAGES WERE OBSERVED. FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE NEITHER STENT NOR INTRODUCER TUBE WERE RECEIVED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE INVOLVED LAKE REGION AND CORDIS LOT NUMBER 10358980. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE STENT MIGRATION COULD NOT BE CONFIRMED DUE TO THE NATURE OF COMPLAINT; HOWEVER, MIGRATION IS A KNOWN EVENT THAT CAN OCCUR WITH STENTING AND IS LISTED IN THE INSTRUCTIONS FOR USE. THE MARKER BAND APPEARING DARK WAS NOT CONFIRMED SINCE NO STENT WAS RECEIVED. THE CAUSE OF THE EVENTS EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENTS AS REPORTED. IT WAS REPORTED THAT THE PHYSICIAN WITHDREW BOTH THE DELIVERY WIRE AND THE PROWLER WHEN THE STENT MIGRATED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THAT ¿IF STENT POSITIONING IS SATISFACTORY, CAREFULLY RETRACT THE INFUSION CATHETER, WHILE MAINTAINING THE POSITION OF THE DELIVERY WIRE.¿ SINCE THERE WERE NO MANUFACTURING ISSUES FOUND TO BE RELATED TO THE EVENT, AND MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT VERTEBRAL ARTERY ANEURYSM, AN ENTERPRISE VRD (ENC452212/10358980) MIGRATED FROM THE INTENDED SITE, AND THE PHYSICIAN THOUGHT THE PROXIMAL MARKER OF THE DELIVERY WIRE APPEARED DARKER THAN USUAL IN ANGIOGRAPHY. A PROWLER SELECT PLUS (45 ANGLE, LOT UNKNOWN) WAS FIRST POSITIONED OVER THE DISTAL SIDE OF THE ANEURYSM NECK. THE ECHELON 14 MICROCATHETER WAS THEN INTRODUCED INTO THE ANEURYSM, AND THE SCEPTER BALLOON CATHETER WAS POSITIONED AT THE PROXIMAL RIM OF THE ANEURYSM NECK. THE ENTERPRISE VRD WAS DEPLOYED AFTER HALF OF A COSMOS 18 COIL (TERUMO, 6X19) WAS LOOPED IN THE ANEURYSM. THE COSMOS WAS FULLY DETACHED FOLLOWING THE DEPLOYMENT. THE DELIVERY WIRE WAS THEN KEPT IN THE POSITION TO USE AS THE MARKER FOR GUIDING THE SCEPTER FROM OUTSIDE TO INSIDE OF THE VRD. THE PHYSICIAN THEN WITHDREW BOTH THE DELIVERY WIRE AND THE PROWLER, BUT THE VRD MIGRATED PROXIMALLY. FORTUNATELY THE ANEURYSM NECK WAS STILL COVERED BY THE FLARED PART OF THE GRAFTED VRD TO PREVENT THE COIL MIGRATION. IT WAS REPORTED THAT THE STENT REMAINED GRAFTED IN THE PATIENT TO HOLD THE COILS DESPITE THE MIGRATION. THE PHYSICIAN WAS ABLE TO FULLY EMBOLIZE THE ANEURYSM, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE PHYSICIAN THOUGHT THE PROXIMAL MARKER OF THE DELIVERY WIRE APPEARED FAR DARKER THAN USUAL IN THE ANGIOGRAPHY. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THE DEVICE APPEARED NORMAL PRIOR TO USE. THERE WAS NO RESISTANCE WHILE THE ENTERPRISE WAS ADVANCED THROUGH THE PROWLER, AND EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE DURING THE PROCEDURE. THE ENTERPRISE HAD NOT BEEN PREVIOUSLY RE-CAPTURED, AND THE MICROCATHETER HAD NOT BEEN RE-SHAPED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253555 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10358980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention