BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001898 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01227
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SCANNING ELCTRON MICROSCOPY (SEM) ANALYSIS NOTED SLIGHT STENT IMPRESSIONS. BASED ON THE SEM ANALYSIS, IT IS LIKELY THAT THE STENT WAS ORIGINALLY CRIMPED ON THE BALLOON; HOWEVER, IT IS UNKNOWN HOW TIGHTLY THE STENT MAY HAVE BEEN CRIMPED AND WHEN THE STENT MAY HAVE DISLODGED FROM THE BALLOON.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE STENT WAS NOT RETURNED. THE BALLOON HAD RELAXED FOLDS. THERE WERE NO CRIMP MARKS VISIBLE ON THE BALLOON. THE PROXIMAL AND DISTAL BALLOON MARKERS WERE SMASHED, WHICH MAY HAVE OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS AS THERE WAS NO RESISTANCE REPORTED ADVANCING THE SDS OVER THE GUIDE WIRE. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. INFORMATION RECEIVED FROM THE ACCOUNT STATED THERE WAS NO ISSUE NOTED WITH THE STENT DURING USE; HOWEVER, NO CRIMP MARKS WERE FOUND ON THE BALLOON DURING ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR MISSING STENTS FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS. IT IS UNKNOWN IF ANYTHING ELSE CROSSED. NO PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THIS IS BEING FILED BASED ON THE RETURNED DEVICE ANALYSIS WHICH NOTED A DISLODGED STENT WITH NO VISIBLE CRIMP MARKS ON THE BALLOON.

    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 0100541

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR