BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX23MM NO TIP

    MDR report key: 7686403 · Received July 13, 2018

    Report

    Report Number
    1226348-2018-00649
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 25, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    UDI-DI
    10886704075363
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: 2 MM X 3 CM GALAXY G3 MINI (GLM920030/S15138), 3 MM X 4 CM GALAXY G3 MINI (GLM930040/UNK LOT), PROWLER SELECT LP/ES (606-S155X/17687035) MICROCATHETER. INITIAL REPORTER FIRST NAME, PHONE, FAX, & E-MAIL WERE NOT REPORTED. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENTERPRISE 2 STENT-ASSISTED COIL EMBOLIZATION OF A 4.9 MM X 4.6 MM (4.4 MM NECK) LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 2 MM X 3 CM GALAXY G3 MINI (GLM920030/S15138) THERMO-MECHANICAL COIL WAS ADVANCED TO THE MICROCATHETER TIP IN THE EXISTING COIL MASS, BUT THE PHYSICIAN FELT THE COIL WAS NO LONGER RESPONDING TO ADVANCEMENT OR WITHDRAWAL AND MAY HAVE STRETCHED. THE PROWLER LP/ES (606-S155X/17687035) MICROCATHETER AND COIL WERE PULLED BACK TOGETHER AS A UNIT FROM THE COIL MASS. UPON THEIR WITHDRAWAL, THE PROXIMAL 1 CM OF THE PREVIOUS 3 MM X 4 CM GALAXY G3 MINI (GLM930040/UNK LOT) COIL CAME OUT OF THE ANEURYSM. THE MICROCATHETER AND 2 MM X 3 CM GALAXY G3 MINI COIL WERE REMOVED FROM THE PATIENT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DETERMINED THAT THE COIL EMBOLIZATION WAS COMPLETE. A 4 MM X 23 MM ENTERPRISE 2 STENT (ENF402300/UNK LOT) WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM. THE SALES REPRESENTATIVE GENTLY REMOVED THE COIL FROM THE MICROCATHETER AND NO VISIBLE DAMAGE WAS NOTED TO THE EMBOLIC COIL. REPORTEDLY, NO ADDITIONAL INTERVENTION WAS PERFORMED TO ADDRESS THE COIL THAT PROTRUDED FROM THE ANEURYSM AND THERE ARE NO PLANS TO PERFORM ADDITIONAL COIL EMBOLIZATION AT A LATER DATE. THE COIL WAS LEFT IN PLACE TO ENDOTHELIALIZE. THERE WAS NO EVIDENCE OF THROMBUS FORMATION AT THE SITE OF THE PROTRUDED COIL AND NO SIGN OF FLOW RESTRICTION/REDUCTION. THE SURGERY WAS DELAYED FIVE MINUTES DUE TO THE EVENT. THE SALES REPRESENTATIVE INDICATED THAT THE EXACT ISSUE REMAINS UNCLEAR BUT THE EVENT MAY HAVE BEEN RELATED TO COIL ENTANGLEMENT. THE SUSPECTED CAUSE OF COIL ENTANGLEMENT WAS NOT REPORTED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE DEVICES WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL DELIVERY SYSTEMS WERE PREPPED WITHOUT ANY DIFFICULTY. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. PRIOR TO THE 2 MM X 3 CM GALAXY G3 MINI COIL, FIVE COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE THROUGH THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THE ENTERPRISE 2 STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE COMPLAINT THAT THE STENT FAILED TO MAINTAIN THE EMBOLIC COIL WITHIN THE CONFINES OF THE TARGET ANEURYSM COULD NOT BE CONFIRMED. IN ADDITION, THIS COMPLAINT IS SPECIFIC TO THE OPERATIONAL CONTEXT AND CANNOT BE EVALUATED IN THE LAB. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. COIL MIGRATION/PROLAPSE INTO NORMAL VESSELS ADJACENT TO THE ANEURYSM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AND STENT-ASSISTED COIL EMBOLIZATION PROCEDURES. THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE ANEURYSM NECK SIZE/VESSEL CHARACTERISTICS, COIL ENTANGLEMENT/DEVICE INTERACTION, AND CIRCUMSTANCES OF THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00678, 3008114965-2018-00679, AND THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENTERPRISE 2 STENT-ASSISTED COIL EMBOLIZATION OF A 4.9 MM X 4.6 MM (4.4 MM NECK) LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 2 MM X 3 CM GALAXY G3 MINI (GLM920030/S15138) THERMO-MECHANICAL COIL WAS ADVANCED TO THE MICROCATHETER TIP IN THE EXISTING COIL MASS, BUT THE PHYSICIAN FELT THE COIL WAS NO LONGER RESPONDING TO ADVANCEMENT OR WITHDRAWAL AND MAY HAVE STRETCHED. THE PROWLER LP/ES (606-S155X/17687035) MICROCATHETER AND COIL WERE PULLED BACK TOGETHER AS A UNIT FROM THE COIL MASS. UPON THEIR WITHDRAWAL, THE PROXIMAL 1 CM OF THE PREVIOUS 3 MM X 4 CM GALAXY G3 MINI (GLM930040/UNK LOT) COIL CAME OUT OF THE ANEURYSM. THE MICROCATHETER AND 2 MM X 3 CM GALAXY G3 MINI COIL WERE REMOVED FROM THE PATIENT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DETERMINED THAT THE COIL EMBOLIZATION WAS COMPLETE. A 4 MM X 23 MM ENTERPRISE 2 STENT (ENF402300/UNK LOT) WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM. THE SALES REPRESENTATIVE GENTLY REMOVED THE COIL FROM THE MICROCATHETER AND NO VISIBLE DAMAGE WAS NOTED TO THE EMBOLIC COIL. REPORTEDLY, NO ADDITIONAL INTERVENTION WAS PERFORMED TO ADDRESS THE COIL THAT PROTRUDED FROM THE ANEURYSM AND THERE ARE NO PLANS TO PERFORM ADDITIONAL COIL EMBOLIZATION AT A LATER DATE. THE COIL WAS LEFT IN PLACE TO ENDOTHELIALIZE. THERE WAS NO EVIDENCE OF THROMBUS FORMATION AT THE SITE OF THE PROTRUDED COIL AND NO SIGN OF FLOW RESTRICTION/REDUCTION. THE SURGERY WAS DELAYED FIVE MINUTES DUE TO THE EVENT. THE SALES REPRESENTATIVE INDICATED THAT THE EXACT ISSUE REMAINS UNCLEAR BUT THE EVENT MAY HAVE BEEN RELATED TO COIL ENTANGLEMENT. THE SUSPECTED CAUSE OF COIL ENTANGLEMENT WAS NOT REPORTED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE DEVICES WERE STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL DELIVERY SYSTEMS WERE PREPPED WITHOUT ANY DIFFICULTY. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. PRIOR TO THE 2 MM X 3 CM GALAXY G3 MINI COIL, FIVE COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE THROUGH THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. THE ENTERPRISE 2 STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528973 ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC 10886704075363

    Patients

    Seq Age Sex Outcome Treatment
    1