BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3163206 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03650
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: CHOICE PT ES; GUIDE CATH: MEDTRONIC AR1. (B)(4): INCORRECT PREP AND EXCESSIVE FORCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) FOR EXPELLING AIR FROM THE DELIVERY SYSTEM WHICH IS PRIOR TO INSERTING INTO THE ANATOMY. FURTHER, THE IFU STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE WHERE THE PATIENT PRESENTED WITH AN STEMI AND THROMBUS OF THE NARROW, MID RIGHT CORONARY ARTERY (RCA) THE GUIDE WIRE AND GUIDE CATHETER WERE ADVANCED AND POSITIONED WITHOUT ISSUE. A THROMBECTOMY WAS PERFORMED AND THE 3.5 X 15 MM MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS) WAS DELIVERED. THE DEVICE WAS PREPARED INSIDE THE ANATOMY USING NEGATIVE VACUUM AT THE TARGET AREA AND DEPLOYED WITHOUT ISSUE USING A SHORT EXPANSION AND DEFLATION. DURING ATTEMPTED REMOVAL THE BALLOON BECAME STUCK INSIDE THE GUIDE CATHETER CURVE AND COULD NOT BE REMOVED. IT WAS NOTED THE PATIENT EXPERIENCED 'BLOOD PRESSURE CURVATURE' LOSS ON THE MONITOR AS THE DEVICE COULD NOT BE REMOVED. THERE WAS NO REPORT OF TREATMENT/INTERVENTION GIVEN. EXTREME FORCE WAS USED AND THE BALLOON AND GUIDE WIRE WERE SUCCESSFULLY REMOVED WHILE GENTLY PUSHING THE GUIDE CATHETER. POST PROCEDURE ANGIOGRAPHY OF THE VESSEL APPEARED GOOD. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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
    264141 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3020741

    Patients

    Seq Age Sex Outcome Treatment
    1