BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1914675 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02603
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE ON THE ENTIRE LENGTH OF THE CATHETER AND IN THE GUIDE WIRE LUMEN, WHICH IS NOT CONSISTENT WITH THE REPORTED INFORMATION WHICH STATED THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS CONTRAST ON THE BALLOON. THE FIRST SEVEN ROWS OF THE PROXIMAL END OF THE STENT IMPLANT WERE ON THE DISTAL BALLOON TAPER. THE MIDDLE AND DISTAL END OF THE STENT IMPLANT WERE STRETCHED PAST THE TIP. THE STENT IMPLANT WAS EASILY DISLODGED ONCE IT WAS DECONTAMINATED. THERE WERE BENT STRUTS IN THE FIRST TWO ROWS OF PROXIMAL STRUTS. CRIMP MARKS WERE VISIBLE ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE MIDDLE AND DISTAL ENDS OF THE BALLOON WERE TIGHTLY FOLDED AND THE PROXIMAL END HAD RELAXED FOLDS. THE DISTAL EDGE OF THE SOFT TIP WAS PINCHED. SINCE THE TIP DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE PINCHED MATERIAL MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE DISPENSER COIL AND PROTECTIVE SHEATH WERE NOT RETURNED, WHICH MAY HAVE AIDED THE INVESTIGATION. THE PROXIMAL STENT OUTER DIAMETER DIMENSIONS WERE OUTSIDE OF THE ACCEPTED MANUFACTURING SPECIFICATION, HOWEVER, BECAUSE STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WITHIN THE REQUIRED SPECIFICATION, THIS OVER-SIZING MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON SHOULDERS. THE DISTAL AND MIDDLE OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. DIFFICULTY REMOVING THE SDS FROM THE HOOP MAY BE ATTRIBUTED TO BUT NOT LIMITED TO A KINK IN THE SHAFT OR CRIMPED STENT, INTERACTION WITH THE STYLET OR SHEATH WITH THE HOOP, DAMAGE TO THE HOOP, OR IMPROPER HANDLING OR REMOVAL TECHNIQUE AT THE ACCOUNT. ADDITIONALLY, FACTORS THAT CAN INFLUENCE A LOOSE STENT (STENT MOVEMENT ON THE BALLOON) INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER STENT CRIMPING, HANDLING DURING MANUFACTURING OR AT THE ACCOUNT, PATIENT ANATOMICAL MORPHOLOGY, PHYSICIAN TECHNIQUE, OR INTERACTION WITH ACCESSORY DEVICES OR PREVIOUSLY IMPLANTED STENTS. CONSIDERING THE EXTENT OF THE DAMAGE (STRETCHED AND BENT) NOTED TO THE STENT, IT IS UNLIKELY THAT THIS WAS A PRE-EXISTING CONDITION AS THE PROTECTIVE SHEATH WOULD NOT HAVE FIT OVER THE STENT IMPLANT. IN THIS CASE, CONSIDERING THE EXTENT OF THE DAMAGE NOTED TO THE PRODUCT, IT IS POSSIBLE THE SDS WAS USED; 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 THAT COULD HAVE CONTRIBUTED TO THIS REPORT. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY REMOVING THE SDS FROM THE HOOP AND STENT DAMAGE COULD NOT BE DETERMINED. ALL SDS ARE 100% INSPECTED FOR DAMAGE/KINKS TO THE SDS, STENT AND DISPENSER HOOP. IN ADDITION, A QUALITY CONTROL (QC) AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. THERE WAS RESISTANCE DURING REMOVAL OF THE XIENCE V 2.75 X 28 FROM THE PACKAGE (COIL DISPENSER) AND THE STENT IMPLANT BECAME DAMAGED. WHEN THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE COIL DISPENSER THE STENT WAS NOTED TO BE LOOSELY HELD ON THE BALLOON AND SO IT WAS NOT USED FOR FEAR IT COULD BECOME DISLODGED. THE STENT WAS ALSO NOTED TO BE STRETCHED BEYOND THE BALLOON. THEREFORE, THE DEVICE WAS NOT USABLE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS PRODUCT. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE. THE ANALYSIS OF THE RETURNED DEVICE, WHICH REVEALED THE STENT IMPLANT WAS RETURNED ON THE BALLOON; HOWEVER DURING DECONTAMINATION WHEN THE DEVICE WAS SOAKED, THE STENT IMPLANT EASILY BECAME DISLODGED.

    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-CLONMEL 0030241

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR