BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 2180107 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05268
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - REMOVED. EVALUATION SUMMARY: EVALUATION OF THE RETURNED ZETA STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE ENTIRE LENGTH OF THE SDS. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE HYPOTUBE WAS SEPARATED 18.7 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS SEPARATED AT THE SAME LOCATION. THE JACKET MATERIAL AT THE HYPOTUBE SEPARATION WAS STRETCHED AND JAGGED. THERE WERE MULTIPLE KINKS AND BENDS NOTED TO THE SDS. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE HYPOTUBE CAN LEAD TO WEAKENING OF THE HYPOTUBE MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IN THIS CASE, THE PATIENT ANATOMY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT THE SHAFT KINKED DURING ADVANCEMENT IN THE LESION AS RESISTANCE WAS ENCOUNTERED AS THERE WAS NO DAMAGE NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE. FURTHER HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE HYPOTUBE SEPARATING. A SEARCH OF THE DEVICE LOT HISTORY RECORD INDICATED NO NONCONFORMANCE MATERIAL RECORDS FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS. IN SUMMARY, BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY 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 EVALUATION. 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 ADVANCEMENT OF THE ZETA STENT DELIVERY SYSTEM IN A LONG AND DIFFICULT LESION SITE, THE SHAFT KINKED DURING THE PROCEDURE. AS A RESULT, THE BALLOON WOULD NOT EXPAND AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ZETA FAILED TO CROSS TO THE LESION SITE, AND THAT NO ATTEMPT WAS MADE TO INFLATE THE STENT DELIVERY SYSTEM BALLOON. HOWEVER, RETURNED DEVICE ANALYSIS NOTED A SEPARATED HYPOTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0102241

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR