BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 2182999 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05358
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX ZETA STENT DELIVERY SYSTEM (SDS)NOTED NO BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BUT NOT BETWEEN THE MARKERS. THE PROXIMAL END OF THE STENT IMPLANT WAS LOCATED DISTAL TO THE PROXIMAL BALLOON MARKER. THE STENT WAS NOT LOOSE AS REPORTED. THERE WERE CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON BETWEEN THE PROXIMAL BALLOON MARKER, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE INNER DIAMETER OF THE PROTECTIVE SHEATH AND THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. STENT MISLOCATION/MOVEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING DURING PRODUCT PREPARATION FOR USE, OR INTERACTION WITH ACCESSORY DEVICES. THE STENT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE STENT BEING PARTIALLY EXPANDED. IT IS POSSIBLE THE PROTECTIVE SHEATH AND STENT WERE INADVERTENTLY HANDLED DURING REMOVAL, RESULTING IN THE STENT MOVING ON THE BALLOON; HOWEVER THIS COULD NOT BE CONFIRMED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE STENT MOVEMENT COULD NOT BE DETERMINED HOWEVER THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED 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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IN THE MID LEFT ANTERIOR DESCENDING ARTERY PROCEDURE, THE 3.5 X 15 MULTILINK ZETA STENT 'SLIPPED OFF THE BALLOON' WHEN THE SHEATH WAS REMOVED. THE STENT WAS NOTED AS HALF OFF THE BALLOON AND POSSIBLY LOOSE. THERE WAS NO PATIENT INVOLVEMENT. A SECOND 3.5 X 15 ZETA WAS USED IN THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED DUE TO THE DEVICE ISSUE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0092141

    Patients

    Seq Age Sex Outcome Treatment
    1