BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173410 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05095
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) NOTED BLOOD AND CONTRAST IN THE BALLOON AND IN THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH A RUPTURE WHILE IN THE PATIENT ANATOMY. A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON BELOW RATED BURST PRESSURE (RBP) AND FLUID WAS OBSERVED LEAKING AT A PINHOLE IN THE PROXIMAL TAPER. THERE WERE NO SCRATCHES VISIBLE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THAT THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER DIAMETER (OD) SURFACE. THE LEAK WAS LOCATED AT THE EDGE OF A FOLD NEAR THE PROXIMAL TAPER. MECHANICAL DAMAGE WAS DOCUMENTED AT AND AROUND THE LEAK ON THE OD SURFACE. NO SIGNIFICANT FEATURES WERE OBSERVED ON THE INNER DIAMETER (ID) SURFACE. A SECOND, SMALLER LEAK WAS ALSO DOCUMENTED IN A FOLD NEAR THE MAIN LEAK. MECHANICAL DAMAGE WAS FOUND EXTENDING FROM THE SECOND LEAK ON THE ID SURFACE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. IT IS POSSIBLE AN INTERACTION WITH OTHER DEVICES AND/OR THE MILDLY TORTUOUS/MODERATELY CALCIFIED LESION MAY HAVE DAMAGED (SCRATCHED) AND WEAKENED THE BALLOON MATERIAL, SUCH THAT THE BALLOON RUPTURED UPON THE SECOND INFLATION AT 10 ATMOSPHERE, WHICH IS BELOW THE RBP. BALLOON RUPTURE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH THE STENT OR OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THERE WAS A KINK IN THE SHAFT DISTAL TO THE GUIDE WIRE EXIT NOTCH AND A BEND IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. THIS DAMAGE WAS NOT REPORTED OR NOTED DURING PRODUCT INSPECTION PRIOR TO USE AND MAY HAVE OCCURRED DURING OR AFTER AN ATTEMPT TO ADVANCE THE SDS IN THE GUIDING CATHETER OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING 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 HAV BEEN NO OTHER INCIDENTS FOR BALLOON RUPTURES OR KINKS/BENDS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED BALLOON RUPTURE AND KINK/BEND ARE LIKELY RELATED TO OPERATIONAL CONTEXT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SECOND POST STENT DEPLOYMENT INFLATION OF THE MILDLY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC DE NOVO, MID TO PROXIMAL LESION BELOW THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY THE BALLOON RUPTURED. THE BALLOON WAS USED ONCE AT 10 ATMOSPHERE (ATM) FOR 20 SECONDS, BEFORE IT RUPTURED DURING THE SECOND INFLATION ATTEMPT AT 10 ATM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A 3.5 X 12 MM NON-ABBOTT BALLOON WAS USED 3 TIMES AT 20 ATM TO FULLY APPOSE THE STENT TO THE VESSEL WALL AND TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. 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 9101641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: SION, GUIDE CATH: RADIGUIDE 6F