BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 3173270 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03772
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT AND STENT DAMAGE WERE CONFIRMED. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 THAT WOULD 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE. THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. THE ANGIOGRAM REVEALED A LESION AND USING A FEMORAL ARTERY ACCESS APPROACH THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED, DE NOVO PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION WAS PRE-DILATATED USING A 1.5 X 10 MM AND A 2.0 X 10 MM BALLOON DILATATION CATHETER (BDC) AT 12 ATMOSPHERE (ATM). THE 3.5 X 28 MM MULTILINK ZETA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION LOCATION, HOWEVER, THE SDS COULD NOT CROSS THE LESION. WHILE ADVANCING USING FORCE RESISTANCE WAS MET AND MULTIPLE ATTEMPTS TO CROSS WERE MADE; THE SDS PROXIMAL SHAFT WAS BROKEN. THE SDS WAS REMOVED FROM THE ANATOMY AND IT WAS NOTED THAT THE DISTAL STENT STRUTS WERE FLARED. A 3.5 X 28 MM VISION SDS WAS USED TO CROSS THE LESION AND WAS DEPLOYED AT 14 ATM WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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
    273627 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2040341

    Patients

    Seq Age Sex Outcome Treatment
    1