BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3031742 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01938
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INFLATION ISSUE AND DAMAGE WERE CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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). 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 THE PROCEDURE IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, MID RIGHT CORONARY ARTERY FOR TREATMENT OF A DE NOVO LESION, PRE-DILATATION WAS PERFORMED USING A 2.0X08 TREK BALLOON. A 3.5X12 RX MULTI-LINK 8 STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT. THE STENT BALLOON DID NOT INFLATE. THE DEVICE WAS REPLACED WITH ANOTHER MULTI-LINK 8 STENT SYSTEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATES THAT RESISTANCE WAS FELT DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM DUE TO THE ANATOMY. AFTER REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE ANATOMY, UNSPECIFIED DAMAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135222 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1062441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR