BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME10 3MM X 5.4CM

    MDR report key: 7789337 · Received August 16, 2018

    Report

    Report Number
    3008114965-2018-00713
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Report Date
    July 26, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077800
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). CORRECTED SECTIONS: H6 - DEVICE CODE - REMOVE 1212. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 3.5 X 2.8 X 2.7MM RUPTURED ANEURYSM, THE 3MM X 5.4CM MICRUSFRAME10 (MFR100305/UNK LOT) THERMO-MECHANICAL COIL APPEARED TO FIT PERFECTLY IN THE BEGINNING OF THE CASE, BUT THE PROXIMAL PORTION OF THE EMBOLIC COIL FAILED TO BREAK. ¿THE LAST PART OF THE COIL DID NOT PERFORM LOOPS ANYMORE". THE COIL WAS ¿SUPPLIED¿ WITH A 3MM NON-CERENOVUS COIL, WHICH WAS CONSIDERED TOO SMALL. THERE WAS NO REPORT OF CONSEQUENCE OF IMPACT TO THE PATIENT. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION. THE MICRUSFRAME WAS NOT RETURNED FOR INVESTIGATION. IN ADDITION, THE STERILE LOT NUMBER WAS NOT AVAILABLE; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. PROCEDURAL IMAGING PROVIDED BY THE CUSTOMER WAS REVIEWED AND THE RESULTS ARE AS FOLLOWS: FILMS SHOWED THE COIL BEING INSERTED INTO AN ANEURYSM WITH CATHETER PUSHBACK. THE CATHETER PUSHBACK PREVENTED THE COIL FROM BEING DEPLOYED INTO THE ANEURYSM. IT WOULD BE EXPECTED FOR THE COIL TO FIT INTO THE ANEURYSM WITH THE PROXIMAL PORTION OF THE COIL TO FOLD/COIL AS IT WAS PUSHED INTO THE ANEURYSM. INSTEAD, THE MICROCATHETER BACKED OUT AS THE LAST PORTION OF THE COIL WAS BEING DELIVERED. THE SIZE OF THE COIL MAY BE APPROPRIATE FOR THE ANEURYSM, BUT THIS COIL WAS TOO LONG TO ALLOW FULL DEPLOYMENT INTO THE ANEURYSM. AN ALTERNATIVE APPROACH MAY HAVE BEEN TO ADVANCE THE MICROCATHETER FURTHER INTO THE ANEURYSM, OR, THE USE A SHORTER COIL THAN THE 5.4 CM COIL USED. THE PUSH BACK OF THE MICROCATHETER AS THE PROXIMAL END OF THE COIL IS INSERTED INTO THE ANEURYSM IS VERY COMMON WITH ALL SYSTEMS. WHILE IT MAY INDICATE LACK OF SUPPORT BY THE MICROCATHETER IT IS STILL COMMONLY OBSERVED WITH MANY DIFFERENT TYPES OF MICROCATHETERS, FIRM OR SOFT. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION OBSERVED, AND THE EVENT APPEARS TO BE RELATED TO DEVICE SELECTION. BASED ON THE REVIEW OF PROCEDURAL FILMS, THE REPORTED CUSTOMER COMPLAINT OF POSITIONING DIFFICULTY-POOR CONFORMABILITY WAS CONFIRMED. POSITIONING DIFFICULTY IS A KNOWN PROCEDURAL COMPLICATION ASSOCIATED WITH THE MICRUSFRAME THERMO-MECHANICAL COIL. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM SIZE/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE MANIPULATION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. DATE OF EVENT: THE EVENT OCCURRED IN 2018; HOWEVER, THE MONTH AND DAY WERE NOT REPORTED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. REVIEW OF THE IMAGING PROVIDED BY THE CUSTOMER IS PENDING AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(6). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 3.5 X 2.8 X 2.7MM RUPTURED ANEURYSM, THE 3MM X 5.4CM MICRUSFRAME10 (MFR100305/UNK LOT) THERMO-MECHANICAL FRAMING COIL APPEARED TO FIT PERFECTLY IN THE BEGINNING OF THE CASE, BUT THE PROXIMAL PORTION OF THE EMBOLIC COIL FAILED TO BREAK. THE COIL WAS SUPPLIED WITH A 3MM NON-CERENOVUS COIL, WHICH WAS CONSIDERED TOO SMALL. IT WAS FURTHER STATED THAT "THE LAST PART OF THE COIL DID NOT PERFORM LOOPS ANYMORE". THERE WAS NO REPORT OF CONSEQUENCE OF IMPACT TO THE PATIENT. IMAGING WAS PROVIDED BY THE CUSTOMER. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632158 MICRUSFRAME10 3MM X 5.4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 10886704077800

    Patients

    Seq Age Sex Outcome Treatment
    1 3MM NON-CERENOVUS COIL