BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141274 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04492
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND USE IN THE PATIENT ANATOMY. THERE WAS A KINK IN THE SHAFT 10.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THE SHAFT WAS ALSO KINKED 59 CM DISTAL TO THE STRAIN RELIEF TUBING THEN STRETCHED FOR A LENGTH OF 2 CM. FACTORS THAT COULD HAVE CONTRIBUTED TO DIFFICULTIES INFLATING/DEFLATING THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO: PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, CONTRAST CONCENTRATION, BALLOON MATERIALS, MANUFACTURING, INFLATION LUMEN OBSTRUCTION, INTERACTION WITH ACCESSORIES (INDEFLATOR, ROTATING HEMOSTATIC VALVE, OR GUIDING CATHETER), PLACEMENT OF THE BALLOON WITHIN LESION, OR INFLATION/DEFLATION TECHNIQUE. TO ENSURE THAT THIS IS NOT A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR BALLOON DAMAGE AND LEAK TESTED DURING MANUFACTURING. THE OVERALL TOTAL LENGTH OF THE SDS WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE SDS TO THE RATED BURST PRESSURE (RBP) TO MEASURE THE DEFLATION TIMES. THE DEFLATION TIMES DID NOT MEET MANUFACTURING CRITERIA DUE TO THE STRETCHING NOTED TO THE SHAFT. REPORTEDLY, NO DAMAGE WAS BEING OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT IS POSSIBLE THE SHAFT WAS INADVERTENTLY HANDLED DURING PREPARATION FOR USE, RESULTING IN THE STRETCHED AND KINKED 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 THE COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR INFLATION/DEFLATION ISSUES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY INFLATING AND DEFLATING THE BALLOON APPEARS TO BE RELATED TO THE STRETCHED SHAFT; HOWEVER A CONCLUSIVE CAUSE FOR THE STRETCHED AND KINKED SHAFT COULD NOT BE DETERMINED. 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 THE PROMUS OTW STENT DELIVERY SYSTEM (SDS) WAS BEING USED TO TREAT AN IN-STENT RESTENOSIS IN THE NON-CALCIFIED AND MILDLY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. THE BALLOON WAS SLOW INFLATING TO 16 ATMOSPHERES, AND THEN THE BALLOON FAILED TO DEFLATE UNTIL A SYRINGE WAS ATTACHED AND USED TO DEFLATE THE BALLOON. THERE WERE NO COMPLICATIONS DURING REMOVAL OF THE SDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0102741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention STENT: MEDTRONIC ENDEAVOR