BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073346 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03054
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. NO PRE-DILATATION. THE REPORTED APPEARANCE OF AN OVERSIZED BALLOON INFLATION PROFILE MAY BE THE RESULT OF, BUT NOT LIMITED TO: MANUFACTURING, HIGH INFLATION PRESSURES USED AT STENT DEPLOYMENT, LESION CALCIFICATION, INCORRECT VESSEL DIAMETER SIZE MEASUREMENT, INCORRECT MARKER BAND PLACEMENT, IMPROPER PREP OF THE DEVICE SUCH THAT AIR IS WITHIN THE BALLOON OR INCORRECT PRODUCT SIZE SELECTION. TO ENSURE THIS IS NOT RELATED TO A MANUFACTURING DEFICIENCY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY UNIFORMITY OF EXPANSION. ADDITIONALLY A SAMPLING OF CATHETERS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON WORKING LENGTH FOR EVERY SUB-ASSEMBLY CATHETER LOT. RETURN OF THE PROMUS STENT DELIVERY SYSTEM (SDS) MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO USE OF THE PROMUS SDS. IT SHOULD BE NOTED THE PROMUS INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE PROMUS STENT. IT IS POSSIBLE THAT THE FAILURE TO PRE-DILATE THE LESION CONTRIBUTED TO THE BALLOON APPEARING TO BE OVERSIZED. IT WAS REPORTED A DISSECTION WAS NOTED AFTER IMPLANTATION OF THE PROMUS STENT AND ANOTHER STENT WAS IMPLANTED TO TREAT THE DISSECTION. DISSECTION, AS LISTED IN THE PROMUS IFU IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). 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 SIMILAR INCIDENTS REPORTED FOR OVERSIZED BALLOONS 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 OVERSIZED BALLOON COULD NOT BE DETERMINED. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. 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 A KISSING STENT PROCEDURE WAS PERFORMED WITH THE PROMUS RX STENT DELIVERY SYSTEM (SDS) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL ARTERY. PRE-DILATATION WAS NOT PERFORMED PRIOR TO ADVANCEMENT OF THE SDS IN THE CONCENTRIC, DE NOVO, NON-TORTUOUS AND NON-CALCIFIED LAD. A TYPE A VESSEL DISSECTION OCCURRED IN THE LAD AND THE BALLOON IS ALLEGED AS BEING OVERSIZED WHICH CAUSED THE ISSUE. THE PROMUS STENT WAS DEPLOYED AT 8 ATMOSPHERES PRIOR TO THE DISSECTION AND ANOTHER PROMUS STENT WAS USED TO TREAT THE DISSECTION. 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 1020741

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention GUIDE WIRE: PROWATER