BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1936016 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02863
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE STENT DELIVERY SYSTEM (SDS) OR THE STENT IMPLANT, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. FURTHERMORE, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT WITHIN THE BODY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT MANUFACTURING, IMPROPER TECHNIQUE OR HANDLING DURING SHEATH REMOVAL AND PREPARATION FOR USE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY OR PREVIOUSLY IMPLANTED STENTS. ALTHOUGH THE RETURN OF THE XIENCE V SDS MAY HAVE AIDED IN DETERMINING A CONCLUSIVE CAUSE, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO EXPERIENCED DIFFICULTIES. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED; HOWEVER, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND MAY HAVE BEEN RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE STENT MAY HAVE INTERACTED WITH THE LESION AND/OR ACCESSORY DEVICES DURING ATTEMPTED ADVANCEMENT/RETRACTION SUCH THAT THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED IN THE VESSEL, ALTHOUGH THIS CANNOT BE CONFIRMED. THE REPORTED REMOVAL OF FOREIGN BODY AND ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEARS TO BE A SECONDARY EFFECT OF THE STENT DISLODGEMENT AS A BALLOON CATHETER WAS USED TO WITHDRAW THE DISLODGED STENT AND ANOTHER STENT WAS IMPLANTED. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS ALSO SUBJECT TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY AND DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE FAILED TO CROSS AND WHEN WITHDRAWING THE DEVICE BACK TO TRY AND REPOSITION, THE STENT SLIPPED OFF THE BALLOON. THE STENT WAS CRUSHED USING A NON-ABBOTT 4.0 X 20 MM BALLOON CATHETER AND RETRIEVED OUTSIDE OF THE PATIENT. ANOTHER STENT (UNKNOWN TYPE) WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention