BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFREEDOM DRUG COATED CORONARY STENT SYSTEM

    MDR report key: 17487796 · Received August 9, 2023

    Report

    Report Number
    3002806593-2023-00002
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    October 8, 2022
    Report Date
    August 8, 2023
    Manufacturer
    BIOSENSORS EUROPE SA (BESA)
    Product Code
    NIQ
    PMA / PMN Number
    P190020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT BACK TO THE MANUFACTURER AND MANUFACTURER HAVE COMPLETED THE INVESTIGATION OF THE RETURNED DEVICE. BASED ON THE PROVIDED INFORMATION, THE TARGETED LESION WAS A SEVERELY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. HENCE, THERE WAS VERY LIMITED INFORMATION ON THE PROCEDURAL STEPS UNDERTAKEN. NO INFORMATION WAS PROVIDED IF THERE WAS ANY VESSEL PREPARATION HAD BEEN CONDUCTED PRIOR TO THE STENT ADVANCEMENT. FROM THE RETURNED DEVICE ANALYSIS, THERE WAS CATHETER DAMAGE OBSERVED. THE HYPOTUBE WAS OBSERVED TO BE BENT NEAR THE HUB. THE EXIT PORT WAS OBSERVED TO HAVE A TEAR. THE STENT WAS NOT SENT BACK TO THE MANUFACTURER WITH THE RETURNED CATHETER FOR INVESTIGATION. STENT CRIMPED MARKS COULD BE SEEN ON THE BALLOON.THEREFORE, WITH LIMITED INFORMATION, THIS SEEMED TO BE A CASE OF BIOFREEDOM 2.50 X 18 MM STENT FAILURE TO ADVANCE WITH SUBSEQUENT STENT DISLODGEMENT LIKELY DUE TO INSUFFICIENT OR EVEN LACK OF VESSEL PREPARATION AT A SEVERELY CALCIFIED AND TORTUOUS LESION PRIOR TO STENTING. DURING THE MANIPULATION OF THE DELIVERY SYSTEM (I.E., ADVANCEMENT OR WITHDRAWAL OF THE DELIVERY SYSTEM), THE STENT COULD HAVE BEEN TRAPPED AT INADEQUATELY DILATED LESION AND WHEN USED FORCE TO REMOVE THE DELIVERY SYSTEM; THE STENT COULD HAVE DISPLACED. MANUFACTURER HAVE EXAMINED THE MANUFACTURING RECORDS OF THE RELEVANT PRODUCTION LOT W22030347, HAVE IDENTIFIED NO OTHER COMPLAINTS OR ABNORMAL OBSERVATIONS WITH THIS BATCH OF DEVICES. EVENTS LINKED WITH THE DEVICE USAGE REPORTED TO BIOSENSORS ARE DOCUMENTED WITHIN OUR DEVICE RISK ASSESSMENT AND MANAGEMENT SYSTEMS. (B)(4). ALL OF THE DEVICE HISTORY RECORD (DHR) BATCHES OF BIOFREEDOM REPORTED EVENT TO DATE TO BIOSENSORS HAVE BEEN ANALYSED AND WE HAVE CONCLUDED THAT THERE ARE NO CONTRIBUTING FACTORS IN TERMS OF DEVICE MALFUNCTION, DESIGN OR CHANGES IN THE CHARACTERISTICS OR MANUFACTURING ANOMALIES OR FAILURES THAT COULD BE LINKED TO THE EVENTS. IN SUMMARY, WE HAVE NOT IDENTIFIED ANY SIGNALS IN OUR COMPLAINT REPORTING AND TREND ANALYSIS THAT WOULD SUGGEST THAT THERE IS ANY SYSTEMATIC CHANGE IN THE SAFETY AND PERFORMANCE OF THE BIOFREEDOM DELIVERY SYSTEM TILL DATE.

    Description of Event or Problem · 0

    THE INCIDENT OCCURRED IN (B)(6) 2022, HOWEVER, WE (AS THE MANUFACTURER) ARE MADE AWARE OF THIS INCIDENT ON (B)(6) 2023. THE PATIENT WAS A 77-YEAR-OLD MALE PATIENT WITH CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY ANGLE. DUE TO SEVERE VASCULAR CALCIFICATION, THE STENT WAS DISLODGED AND REMOVED BY SURGERY. DESPITE SEVERAL FOLLOW-UP, THERE WAS NO RESPONSE FROM THE PHYSICIAN ON FURTHER INFORMATION REQUESTED FOR THE INVESTIGATION, THEREFORE, INFORMATION ON THE EVENT DETAILS WERE INSUFFICIENT. STENT DISLODGEMENT IS A KNOWN RISK WITHIN THE STENT IMPLANTATION. HOWEVER, THIS EVENT HAS CAUSED SERIOUS INJURY TO THE PATIENT AS THE STENT WAS REMOVED BY SURGERY, THEREFORE, WE HAVE DECIDED TO REPORT IT TO THE COMPETENT THE INCIDENT OCCURRED IN OCTOBER 2022, HOWEVER, WE (AS THE MANUFACTURER) ARE MADE AWARE OF THIS INCIDENT ON (B)(6) 2023. THE PATIENT WAS A 77-YEAR-OLD MALE PATIENT WITH CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY ANGLE. DUE TO SEVERE VASCULAR CALCIFICATION, THE STENT WAS DISLODGED AND REMOVED BY SURGERY. DESPITE SEVERAL FOLLOW-UP, THERE WAS NO RESPONSE FROM THE PHYSICIAN ON FURTHER INFORMATION REQUESTED FOR THE INVESTIGATION, THEREFORE, INFORMATION ON THE EVENT DETAILS WERE INSUFFICIENT. STENT DISLODGEMENT IS A KNOWN RISK WITHIN THE STENT IMPLANTATION. HOWEVER, THIS EVENT HAS CAUSED SERIOUS INJURY TO THE PATIENT AS THE STENT WAS REMOVED BY SURGERY, THEREFORE, WE HAVE DECIDED TO REPORT IT TO THE COMPETENT AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905132 BIOFREEDOM DRUG COATED CORONARY STENT SYSTEM DRUG-COATED-METAL CORONARY ARTERY STENT, NIQ BIOSENSORS EUROPE SA (BESA) BFR1-2518 W22030347

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other