BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2113654 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03874
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. GUIDE WIRE: CHOICE EXTRA SUPPORT, J WIRE. GUIDE CATH: RUNWAY FR4, TERUMO 6FR. STENT: 2.75X12 PROMUS. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO DEFLATE THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO: DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. TO HELP ENSURE THAT THE REPORTED DIFFICULTIES ARE NOT DUE TO MANUFACTURING, 100% OF THE PRODUCTS ARE LEAK TESTED AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY DEFLATION TIMES. THE INDEFLATOR AND PROMUS STENT DELIVERY SYSTEM USED DURING THE PROCEDURE WERE NOT RETURNED, WHICH MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE FOR THE REPORTED DIFFICULTY TO DEFLATE. IT WAS REPORTED THE PATIENT EXPERIENCED CHEST PAIN AND WAS TREATED WITH MEDICATION. ANGINA IS A KNOWN ADVERSE EVENT LISTED IN THE OTW PROMUS INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. 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 HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DEFLATION ISSUES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED PRIOR TO SUCCESSFUL DEPLOYMENT OF A PROMUS STENT IN THE MID RIGHT CORONARY ARTERY (RCA). THE PROMUS OTW STENT WAS DEPLOYED OVERLAPPING THE ALREADY DEPLOYED PROMUS STENT AT 16 ATMOSPHERES AND 30 SECONDS IN THE PROXIMAL RCA. THE BALLOON HOWEVER DID NOT DEFLATE PROPERLY AND SO STANDARD PROCEDURE WAS FOLLOWED IN AN ATTEMPT TO DEFLATE THE BALLOON. ATTEMPTS WERE UNSUCCESSFUL; THEREFORE, THE STENT DELIVERY SYSTEM HAD TO BE GENTLY REMOVED FROM THE PATIENT WITH THE BALLOON STILL INFLATED. VESSEL AND LESION WERE CHARACTERIZED AS BEING MILDY TORTUOUS, MODERATELY CALCIFIED AND DE NOVO. THE PATIENT REPORTEDLY HAD CHEST PAIN, WHICH WAS TREATED WITH NITROGLYCERIN. 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 0112541

    Patients

    Seq Age Sex Outcome Treatment
    1