BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2083262 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03345
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ANALYSIS OF THE RETURNED STENT DELIVERY SYSTEM (SSD) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, ON THE STENT IMPLANT AND BALLOON, CONSISTENT WITH HANDLING AND THE SDS AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE SOFT TIP WAS SEPARATED AT THE DISTAL SEAL, CONFIRMING THE REPORTED INFORMATION. THE FRACTURE FACE WAS STRETCHED AND JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE SOFT TIP WAS BUNCHED DISTAL TO THE CLEAR GAP FOR A LENGTH OF 1MM. THE DISTAL END OF THE TIP WAS FLARED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE SDS OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT ARE NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TIP DETACHMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING (PROCESSING AND/OR HANDLING), HANDLING DURING REMOVAL FROM PACKAGING AT THE ACCOUNT, PREPARATION/USE OF THE CATHETER, OR INTERACTION WITH LESION/ANATOMY OR ACCESSORY DEVICES. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS AND PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY AND TIP TENSILE FORCE. THE INNER DIAMETER OF THE SEPARATED SOFT TIP UP TO THE BUNCHED PORTION WAS MEASURED AND MET MANUFACTURING CRITERIA. AN ATTEMPT WAS MADE TO MEASURE THE INNER DIAMETER OF THE TIP AND GUIDE WIRE LUMEN PROXIMAL TO THE SEPARATION, BUT THE MANDREL WAS NOT ABLE TO ADVANCE PAST THE DRIED BLOOD IN THE GUIDE WIRE LUMEN. AFTER THE SDS WAS SOAKED IN THE WATER BATH AND AFTER THE GUIDE WIRE LUMEN WAS FLUSHED, THE INNER DIAMETER WAS MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. AN ATTEMPT WAS MADE TO BACK LOAD A NEW GUIDE WIRE THROUGH THE SDS, BUT THE GUIDE WIRE WAS NOT ABLE TO ADVANCE PAST THE BLOOD IN THE GUIDE WIRE LUMEN. AFTER THE SDS WAS SOAKED IN THE WATER BATH AND AFTER THE GUIDE WIRE LUMEN WAS FLUSHED, A NEW GUIDE WIRE WAS BACK LOADED THROUGH THE SDS AND REMOVED WITH NO RESISTANCE NOTED. IN THIS CASE, IT IS LIKELY THAT THE COAGULATION OF BLOOD ON THE GUIDE WIRE AND IN THE GUIDE WIRE LUMEN CONTRIBUTED TO THE REPORTED DIFFICULTIES. ADDITIONALLY, AS RESISTANCE WAS MET DUE TO THE BUILD UP OF BLOOD, THIS WOULD CONTRIBUTE TO THE TIP BUNCHING. AND AS THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED, THIS WOULD CONTRIBUTE TO THE TIP STRETCHING AND ULTIMATELY SEPARATING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULTY POSITIONING/REMOVING THE GUIDE WIRE OR TIP DETACHMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE A XIENCE V RX 3.0 X 23 DELIVERY CATHETER MET RESISTANCE AND BECAME STUCK ON A NON-ABBOTT GUIDE WIRE DURING ADVANCEMENT, BEFORE ENTERING THE INTRODUCER SHEATH, OUTSIDE OF THE ANATOMY. WHEN THE DELIVERY CATHETER WAS PULLED BACK THE TIP OF THE CATHETER FELL OFF. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0111241

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC LUGE GUIDE WIRE