BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853296 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07595
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE LOOSE/DISLODGED STENT 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY DURING USE, DESPITE PRE-DILATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER, THE XIENCE PRIME STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY DESCRIBED AS DE NOVO, HEAVILY CALCIFIED AND CHRONIC TOTAL OCCLUSION. AS THE PHYSICIAN RETRACTED THE XIENCE PRIME SDS INTO THE GUIDING CATHETER THE STENT IMPLANT WAS NOTED TO BE LOOSE AND SLIPPED FROM THE SDS. THE STENT IMPLANT WAS LOST INSIDE THE GUIDING CATHETER. THERE WAS REPORTEDLY NO RESISTANCE FELT DURING WITHDRAWAL OF THE SDS INTO THE GUIDING CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE GUIDING CATHETER WITH THE STENT IMPLANT INSIDE TOGETHER WITH THE SDS FROM THE ANATOMY. A NEW GUIDING CATHETER WAS PLACED AND THE PHYSICIAN TREATED THE TARGET LESION WITH A NEW XIENCE PRIME (SAME SIZE) WITH A SATISFACTORY RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT DURING INSERTION OF THE XIENCE PRIME STENT DELIVERY SYSTEM (SDS) INTO A NON-ABBOTT GUIDING CATHETER TO TREAT THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY DESCRIBED AS DE NOVO WITH HEAVY CALCIFICATION AND A CHRONIC TOTAL OCCLUSION, THE STENT IMPLANT MOVED ON THE SDS BALLOON ALTHOUGH THERE WAS NO RESISTANCE NOTED. THE SDS WAS THEN RETRACTED WITH NO RESISTANCE FELT; HOWEVER, DURING RETRACTION, IT WAS NOTED THAT THE STENT IMPLANT HAD MOVED ONTO THE DISTAL SHAFT. THEREFORE, THE PHYSICIAN REMOVED THE GUIDING CATHETER WITH THE STENT IMPLANT INSIDE, TOGETHER WITH THE SDS, FROM THE ANATOMY. A NEW GUIDING CATHETER WAS PLACED AND THE PHYSICIAN TREATED THE TARGET LESION WITH A NEW 2.25X8 MM XIENCE PRIME WITH A SATISFACTORY RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2041641

    Patients

    Seq Age Sex Outcome Treatment
    1