BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2821640 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06993
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD- RE-INSERTION; INDICATION FOR USE, NON-DE NOVO LESION. PATIENT WEIGHT ESTIMATED; ACTUAL WEIGHT (B)(6). EVALUATION SUMMARY: DURING THIS PROCEDURE, THE FIRST OBTUSE MARGINAL DEVELOPED ACUTE OCCLUSION. THIS WAS LIKELY RELATED TO PROXIMAL CIRCUMFLEX MANIPULATION. PROCEDURE CONTINUED. PHYSICIAN WAS SUCCESSFUL IN PCI TO LEFT CIRCUMFLEX AND PROXIMAL FIRST OBTUSE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. STENT DAMAGE WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES: 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, MID CIRCUMFLEX ARTERY, THE XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT CROSS THE TARGET LESION ON TWO SEPARATE ATTEMPTS. THE DEVICE WAS REMOVED AND ADDITIONAL PRE-DILATATION WAS PERFORMED DURING EACH ATTEMPT. A GUIDELINER CATHETER WAS ATTEMPTED TO BE USED FOR ADDITIONAL SUPPORT BUT THE XIENCE V SDS COULD NOT CROSS AND WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE AND WITHOUT RESISTANCE. IT WAS NOTED THAT AFTER REMOVAL THE STENT WAS DAMAGED [BENT STRUT]. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF 4 OTHER STENTS IN THE CIRCUMFLEX AND OBTUSE MARGINAL VESSELS WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENTLY, A USER-FACILITY MEDWATCH REPORT RECEIVED STATES: EVENT DESC: A PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR IN-STENT RESTENOSIS [NON-ABBOTT STENT] OF THE LEFT CIRCUMFLEX AND PROXIMAL TO NEAR OSTIAL FIRST OBTUSE MARGINAL STENOSIS. THE STENT WAS INSERTED INTO GUIDELINER AND WOULD NOT PASS THROUGH PROXIMAL LEFT CIRCUMFLEX LESION ON 2 ATTEMPTS. WHEN STENT WAS PULLED IT WAS DAMAGED AN UNUSABLE. PHYSICIAN FELT THE ANGLE OF THE INSERTION INTO THE LEFT CIRCUMFLEX WHICH WAS PREVIOUSLY STENTED CAUSED THE STENT HANGUP.

    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 1120541

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention OTHER: GUIDELINER CATHETER 6 FR V2