BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2983913 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01187
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED STENT, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION WHEN REMOVING THE PROTECTIVE SHEATH OF A 4.0X18 RX MULTI-LINK 8 CORONARY STENT SYSTEM, THE STENT DISLODGED FROM THE BALLOON BEFORE USE IN THE PATIENT AND REMAINED IN THE PROTECTIVE SHEATH. REPORTEDLY, NO RESISTANCE WAS FELT DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. TWO 4.0X15 RX MULTI-LINK 8 STENTS AND ONE 4.0X23 RX MULTI-LINK 8 STENT WERE IMPLANTED TO TREAT THE LESION IN THE HIGHLY CALCIFIED RIGHT CORONARY ARTERY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88598 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2062041

    Patients

    Seq Age Sex Outcome Treatment
    1