BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001875 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01221
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. STENT: 2.5 X 18 MM XIENCE V ((B)(4)); OTHER: ST. JUDE MEDICAL E-TURN Y-CONNECTOR. PATIENT WEIGHT ROUNDED; ACTUAL (B)(6). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE 2.5 X 18 MM XIENCE V ((B)(4), IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE ON THE ENTIRE LENGTH OF THE DEVICE AND IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS NOT RETURNED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE PROXIMAL BALLOON TAPER AND SHOULDER WERE WRINKLED. THE RHV USED IN THE PROCEDURE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE INVESTIGATION. THE SDS WAS NOT ADVANCED THROUGH A NEW RHV OR GUIDING CATHETER BECAUSE THE STENT IMPLANT WAS DISLODGED. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. FACTORS WHICH MAY CONTRIBUTE TO DIFFICULTY ADVANCING AND RETRACTING THE SDS WITH THE GUIDING CATHETER/RHV INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, STENT IMPLANT OUTER DIAMETER, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER/RHV, THE RHV NOT FULLY OPENED, OR DAMAGE TO THE GUIDING CATHETER/RHV. IN THIS CASE, IT IS POSSIBLE AN INTERACTION WITH THE GUIDING CATHETER DURING ADVANCEMENT MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE TO THE STENT AS THERE WAS NO DAMAGE NOTED DURING THE INSPECTION PRIOR TO USE. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE DEVICE. DURING RETRACTION OF THE SDS, THE DAMAGED STENT STRUTS WOULD HAVE INTERACTED WITH THE RHV, CAUSING RESISTANCE AND FURTHER CONTRIBUTING TO THE DAMAGE NOTED TO THE STENT. IT IS UNKNOWN WHEN THE STENT DISLODGED FROM THE FIRST SDS; HOWEVER AS IT WAS NOT REPORTED WITH THE INCIDENT INFORMATION; IT IS POSSIBLE THE STENT DISLODGED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE DIFFICULT TO POSITION IN THE GUIDING CATHETER, NOTED STENT DISLODGEMENT, OR REPORTED DIFFICULTY REMOVING THE SDS COULD NOT BE DETERMINED. 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 HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION/REMOVE OR STENT DAMAGE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 2.5 X 18 MM XIENCE V (LOT 0052141) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION, THEN DURING REMOVAL FROM THE ANATOMY, THE STENT IMPLANT MET RESISTANCE AT THE NON-ABBOTT Y-CONNECTOR. AFTER REMOVAL FROM THE ANATOMY IT WAS NOTED THAT THE STENT PROXIMAL STRUT WAS FLARED. THERE WAS NO REPORTED PATIENT EFFECT. A NEW 2.5 X 18 MM XIENCE V (LOT 0051441) WAS ATTEMPTED BUT COULD NOT REACH THE LESION, AND MET RESISTANCE DURING REMOVAL FROM THE ANATOMY AT THE SAME LOCATION OF THE NON-ABBOTT Y-CONNECTOR. THE XIENCE V WAS REMOVED FROM ANATOMY WITH THE Y-CONNECTOR. THERE WAS NO REPORTED PATIENT EFFECT. A 2.5 X 23 MM XIENCE V STENT IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS DISLODGED AND WAS NOT RETURNED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT RESISTANCE WAS MET DURING ADVANCEMENT OF THE XIENCE V STENT DELIVERY SYSTEM IN THE GUIDE CATHETER.

    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 0052141

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR