BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 2192278 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05522
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RX ZETA STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND ON THE SHAFT, WHICH IS CONSISTENT WITH HANDLING AND/OR ATTEMPTED ADVANCEMENT OF THE DEVICE. THE ANALYSIS CONFIRMED THAT THE STENT IMPLANT WAS DISLODGED AND RETURNED ON THE STYLET. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE BALLOON MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE PROXIMAL END OF THE STENT IMPLANT WAS FOUND TO BE SMASHED. HOWEVER, AS THERE WAS NO REPORT OF ANY DAMAGE OBSERVED DURING INSPECTION PRIOR TO USE, THIS DAMAGE LIKELY OCCURRED FROM HANDLING AFTER THE PROCEDURE. MEASUREMENTS OF THE OUTER DIAMETER (OD) OF THE STENT EXCLUDING THE PROXIMAL END WERE TAKEN AND ALL DIMENSIONS WERE WITHIN MANUFACTURING CRITERIA. THE PROXIMAL OD COULD NOT BE TAKEN DUE TO THE DAMAGE NOTED. THE INNER DIAMETER OF THE RETURNED PROTECTIVE SHEATH WAS ALSO MEASURED AND MET SPECIFICATION. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE FURTHER AIDED THE INVESTIGATION. SINCE THE STENT WAS RETURNED ON THE STYLET, THIS IS INCONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT DISLODGED ONTO THE SHAFT. THE BALLOON WAS ALSO FOUND TO BE LOOSELY-FOLDED, INDICATING THAT THE BALLOON HAD BEEN PRESSURIZED AT SOME POINT. ATTEMPTS WERE MADE TO GET CLARIFICATION FROM THE ACCOUNT REGARDING THE CONDITION OF THE RETURNED DEVICE, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. IT IS POSSIBLE THAT THE STENT WAS REMOVED FROM THE DELIVERY SYSTEM FROM FURTHER HANDLING AT THE ACCOUNT ONCE THE DEVICES WERE REMOVED FROM THE ANATOMY, LIKELY RESULTING IN THE NOTED STENT DAMAGE. AS THE STENT WAS STILL IN A CRIMPED STATE, THE BALLOON WAS LIKELY INFLATED AFTER IT WAS REMOVED FROM THE SDS POST-PROCEDURE, ALTHOUGH THIS COULD NOT BE CONFIRMED. DIFFICULTY POSITIONING THE SDS THROUGH THE GUIDING CATHETER, CAUSING RESISTANCE BETWEEN THE TWO DEVICES MAY BE RELATED TO NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, STENT IMPLANT OUTER DIAMETER, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. FURTHERMORE, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. THERE WAS NO REPORTED INFORMATION ON THE PATIENT ANATOMICAL MORPHOLOGY (TORTUOSITY OR CALCIFICATION), WHICH MAY HAVE AIDED THE INVESTIGATION. IT IS POSSIBLE THAT THE STENT INTERACTED WITH THE GUIDING CATHETER DURING ATTEMPTED ADVANCEMENT AND AS RESISTANCE WAS ENCOUNTERED, IT LIKELY BECAME DISRUPTED ON THE BALLOON AND DISLODGED AS A RESULT. ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FROM THIS LOT. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, ALL PRODUCTS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT MOVEMENT TO VERIFY STENT SECURITY AND DISLODGMENT 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    REPORTEDLY DURING USE OF THE DEVICE IN THE RIGHT CORONARY ARTERY, THE STENT BECAME DISLODGED INSIDE THE GUIDING CATHETER. THE STENT WHICH WAS LOCATED ON THE SHAFT OF THE STENT DELIVERY SYSTEM AND GUIDING CATHETER WERE REMOVED AS ONE UNIT WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A 3.5X28 MM ZETA. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECIEVED CONFIRMING RESISTANCE WAS FELT BETWEEN THE ZETA STENT DELIVERY SYSTEM AND THE NON-ABBOTT GUIDING CATHETER PRIOR TO THE STENT DISLODGEMENT.

    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 0113041

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR