BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2180324 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05270
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    April 13, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS) NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON, CONFIRMING THE REPORTED DISLODGEMENT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IN THIS CASE, IT IS POSSIBLE THAT DURING PREPARATION, POSITIVE PRESSURE WAS APPLIED TO THE SDS, SLIGHTLY EXPANDING THE STENT, SUCH THAT WHEN THE PROTECTIVE SHEATH WAS REMOVED, THE STENT DISLODGED; HOWEVER THIS COULD NOT BE CONFIRMED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL REPORTS FOR THE LOT RELATED TO THE COMPLAINT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS; THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    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 EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION FOR USE, THE STENT DISLODGED OFF THE BALLOON. THE DEVICE WAS NOT USED IN THE ANATOMY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0012841

    Patients

    Seq Age Sex Outcome Treatment
    1