BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1971135 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00478
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 10, 2010
    Manufacturer
    AV-TEMECULA-CT
    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 STENT DELIVERY SYSTEM (SDS) NOTED BLOOD IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT AND ON THE BALLOON. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SDS WAS INSERTED IN TO THE BODY. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE ENTIRE LENGTH OF THE TIP AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE REPORTED ANATOMICAL CONDITIONS WERE MILD TORTUOSITY AND 90% STENOSIS WHICH APPEARS TO HAVE CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. POTENTIAL CAUSES FOR STENT DISLODGEMENT, MAY INCLUDE IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION FOR USE, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION FOR USE, OR INTERACTION OF THE STENT WITH THE LESION, ACCESSORY DEVICES AND/OR PREVIOUSLY IMPLANTED STENTS AND RE-INSERTION OF THE SDS. ANALYSIS NOTED THE STENT IMPLANT HAD DISLODGED PROXIMALLY AND WAS LOOSE ON THE SHAFT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED AND HAD EVIDENCE OF CRIMP MARKS BETWEEN THE MARKERS SUGGESTING THAT THE STENT WAS PROPERLY POSITIONED ON THE BALLOON AT THE TIME OF MANUFACTURING. IT WAS REPORTED THAT THE SDS WAS RE-MOVED FROM THE ANATOMY TO PERFORM ADDITIONAL DILATATION OF THE LESION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. IT IS POSSIBLE THAT HANDLING DURING REMOVAL AND RE-INSERTION COULD HAVE CONTRIBUTED TO LOOSENING THE STENT. ADDITIONALLY, IT WAS ALSO REPORTED THAT DURING PACKING OF THE DEVICE FOR RETURN TO ABBOTT VASCULAR THE STENT HAD COMPLETELY DISLODGED WHICH IS CONSISTENT WITH THE NOTED STENT ON THE SHAFT. ANALYSIS NOTED THE INNER MEMBER WAS BUNCHED FOR A LENGTH OF 1.5 MM DISTAL TO THE PROXIMAL BALLOON MARKER, 2 MM DISTAL TO THE DISTAL BALLOON MARKER FOR A LENGTH OF 1 MM AND PROXIMAL TO THE DISTAL BALLOON MARKER FOR A LENGTH OF 0.5 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THERE WAS A PORTION OF A NON-ABBOTT GUIDE WIRE FROZEN IN THE DISTAL END OF THE SDS AND 3.5 CM OF THE CORE WAS EXTENDING OUT THE TIP OF THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. IT IS POSSIBLE THAT THE NOTED BLOOD IN THE GUIDE WIRE LUMEN COULD HAVE CONTRIBUTED TO THE GUIDE WIRE LOCKING ON THE SDS GUIDE WIRE LUMEN DURING THE PROCEDURE AND SUBSEQUENT HANDLING AND ATTEMPTS TO ADVANCE TO THE LESION RESULTED IN THE INNER MEMBER BUNCHING. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED FAILURE TO CROSS, LOOSE STENT AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, A QUALITY CONTROL (QC) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A TIGHT LESION IN THE LEFT CIRCUMFLEX ARTERY. PREDILATATION WAS PERFORMED WITH A BALLOON CATHETER PRIOR TO THE ATTEMPT TO CROSS THE LESION WITH THE XIENCE V STENT; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS. ADDITIONAL PREDILATATION WAS PERFORMED; HOWEVER, THE SDS STILL WOULD NOT CROSS. THERE WAS NO REPORTED RESISTANCE DURING THE REMOVAL OF THE SDS; HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE STENT HAD MOVED ON THE BALLOON. THE CASE WAS ABANDONED. DURING PACKAGING OF THE DEVICE FOR RETURN THE STENT COMPLETELY DISLODGED. NO PATIENT EFFECTS WERE REPORTED. 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 0072241

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR