BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143331 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04545
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE INFLATION LUMEN AND GUIDE WIRE LUMEN AND ON THE ENTIRE LENGTH, CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A KINK IN THE SHAFT AT THE DISTAL END OF THE STRAIN RELIEF TUBING. THE TOTAL CATHETER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR, FILLED WITH WATER WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WHEN FLUID WAS OBSERVED COMING OUT OF A TEAR IN THE SHAFT PROXIMAL TO THE PROXIMAL BALLOON SEAL. THE DEFLATION TIMES WERE UNABLE TO BE TESTED. THERE WAS NO BALLOON RUPTURE AS REPORTED. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE SHAFT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE LESION/ANATOMY. THE PATIENT ANATOMY WAS NOT DESCRIBED IN THE CASE DESCRIPTION WHICH MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THAT THE SHAFT WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE LESION/ANATOMY AS THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE OR A LEAK NOTED IN THE SDS DURING PREPARATION FOR USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. FURTHER, AS A TEAR IN THE SHAFT OCCURRED, THIS WOULD CONTRIBUTE TO THE BALLOON UNABLE TO DEFLATE. ADDITIONAL HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE NOTED KINK IN THE SHAFT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DEFLATION ISSUES, BALLOON RUPTURES, OR TEARS IN THE SHAFT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE NOTED TEAR IN THE SHAFT COULD NOT BE DETERMINED; HOWEVER THE REPORTED DEFLATION DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND CATHETER LUMEN INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE PREDILATED LEFT ANTERIOR DESCENDING ARTERY, A 2.5 X 15 MM PROMUS WAS INFLATED TO 14 ATMOSPHERE WHEN A STRANGE NOISE WAS HEARD. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, WHEN RETRACTING THE CATHETER IT WAS NOTED THAT THE BALLOON WAS NOT FULLY DEFLATED. IT WAS NOT CLEAR IF THERE WAS A PINHOLE IN THE BALLOON. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT AND A NON-ABBOTT BALLOON WAS USED FOR POST DILATATION OF THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0120241

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR