BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSFRAME10 3MM X 5.4CM

    MDR report key: 8670595 · Received June 5, 2019

    Report

    Report Number
    3008114965-2019-01027
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 13, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077800
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE: PROCODE IS KRD/HCG. LOT NUMBER, EXPIRATION NUMBER: THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING THE ANEURYSM ON THE TERMINAL INTERNAL CAROTID ARTERY (ICA), A LOOP OF THE 3MM X 5.4CM MICRUSFRAME 10 COIL (MFR100305 / UNK LOT) IMPLANTED IN THE TARGET LESION WAS PUSHED OUT INTO THE PARENT VESSEL BY THE REPORTED STIFFNESS OF THE 2MM X 2CM DELTAPLUSH 10 COIL (DPL10020220 / S10016). AS A RESULT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS SUBSEQUENTLY PLACED OVER THE PROTRUDING COIL LOOP TO SECURE THE COIL TO THE PARENT VESSEL WALL. A 2 MM X 2 CM BARRICADE¿ HELICAL COIL (BLOCKADE MEDICAL) WAS USED TO REPLACE THE DELTAPLUSH COIL AFTER THE STENT PLACEMENT WITHOUT INCIDENT; THE COIL WAS PLACED THROUGH THE STRUTS OF THE ATLAS STENT. THE COIL LOOP DID NOT CAUSE ANY RESTRICTION OR REDUCTION IN BLOOD FLOW; THERE WAS NO THROMBOSIS REPORTED AS A RESULT OF THE EVENT. THERE IS NO ADDITIONAL INTERVENTION PLANNED TO ADDRESS THE REMAINING COIL LOOP IN THE PARENT VESSEL; THE COIL LOOP WAS SECURED TO THE PARENT VESSEL WALL BY THE STENT. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED EVENT. THE MICRUSFRAME COIL REMAINS IMPLANTED IN THE PATIENT AND IS THUS, NOT AVAILABLE FOR RETURN. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. COIL POSITIONING DIFFICULTY, ENTANGLEMENT, AND PROTRUSION INTO PARENT VESSEL ARE KNOWN POTENTIAL PROCEDURAL COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION OF CEREBRAL ANEURYSMS. BASED ON THE MINIMAL INFORMATION AVAILABLE FOR REVIEW, IT APPEARS THAT THE USER MAY HAVE HAD DIFFICULTY POSITIONING THE COIL IN THE ANEURYSM AND THE COIL THEN BECAME ENTANGLED WITH A PREVIOUSLY IMPLANTED COIL, RESULTING IN THE REPORTED COIL HERNIATION INTO THE PARENT VESSEL. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE AT THIS TIME; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND DEVICE MANIPULATION, MAY HAVE CONTRIBUTED. SINCE THE REPORTABLE PRODUCT FAILURES COIL ENTANGLEMENT AND PROTRUSION INTO PARENT VESSEL ASSIGNED TO THE MICRUSFRAME COIL REQUIRED SURGICAL INTERVENTION (I.E. PLACEMENT OF A STENT TO SECURE THE COIL TO THE VESSEL WALL) TO PRECLUDE PERMANENT IMPAIRMENT/INJURY, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY¿. THE DELTAPLUSH ENTANGLEMENT EVENT MEETS MDR REPORTING CRITERIA AS A ¿MALFUNCTION¿ SINCE THE COIL DISPLACED A PREVIOUSLY PLACED COIL; HOWEVER, THERE WAS NO EVIDENCE OF A SERIOUS INJURY ASSOCIATED WITH THIS COIL. THE MICRUSFRAME 10 COIL REMAINS IMPLANTED; THE PROTRUDED LOOP HAS BEEN SECURED BY THE USE OF THE STENT. 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 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-01026. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING THE ANEURYSM ON THE TERMINAL INTERNAL CAROTID ARTERY (ICA), A LOOP OF THE 3MM X 5.4CM MICRUSFRAME 10 COIL (MFR100305 / UNK LOT) IMPLANTED IN THE TARGET LESION WAS PUSHED OUT INTO THE PARENT VESSEL BY THE REPORTED STIFFNESS OF THE 2MM X 2CM DELTAPLUSH 10 COIL (DPL10020220/S10016). AS A RESULT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS SUBSEQUENTLY PLACED OVER THE PROTRUDING COIL LOOP TO SECURE THE COIL TO THE PARENT VESSEL WALL. A 2 MM X 2 CM BARRICADE¿ HELICAL COIL (BLOCKADE MEDICAL) WAS USED TO REPLACE THE DELTAPLUSH COIL AFTER THE STENT PLACEMENT WITHOUT INCIDENT; THE COIL WAS PLACED THROUGH THE STRUTS OF THE ATLAS STENT. THE COIL LOOP DID NOT CAUSE ANY RESTRICTION OR REDUCTION IN BLOOD FLOW; THERE WAS NO THROMBOSIS REPORTED AS A RESULT OF THE EVENT. THERE IS NO ADDITIONAL INTERVENTION PLANNED TO ADDRESS THE REMAINING COIL LOOP IN THE PARENT VESSEL; THE COIL LOOP WAS SECURED TO THE PARENT VESSEL WALL BY THE STENT. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED EVENT. THE MICRUSFRAME COIL REMAINS IMPLANTED IN THE PATIENT AND IS THUS, NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465278 MICRUSFRAME10 3MM X 5.4CM MICRUSFRAME KRD MEDOS INTERNATIONAL SARL 10886704077800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 2 MM X 2 CM BARRICADE¿ HELICAL COIL (BLOCKADE)| NEUROFORM ATLAS® STENT SYSTEM (STRYKER)| SL-10® MICROCATHETER (STRYKER)