BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2233263 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06132
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE SHAFT AND BLOOD IN THE HUB, CONSISTENT WITH PREPARATION AND THE SDS BEING ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED TO THE STENT. THE STENT OUTER DIAMETERS WERE NOT MEASURED DUE TO THE FUNCTIONAL TEST INADVERTENTLY BEING COMPLETED FIRST AND THE STENT WAS DEPLOYED. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. AS THE SDS WAS EVENTUALLY ABLE TO CROSS THE LESION, THE REPORTED PHYSICAL RESISTANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PREPARE THE SDS AND NO LEAK WAS NOTED AFTER NEGATIVE WAS PULLED. THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE (RBP) WITH NO DAMAGE OR LEAK NOTED TO THE SDS. AFTER THE SDS WAS LEFT PRESSURIZED TO CHECK FOR LEAKAGE, THE INDEFLATOR MAINTAINED PRESSURE AND NO LEAK WAS NOTED TO THE SDS. IN THIS CASE, IT IS POSSIBLE THERE WAS A FAULTY CONNECTION WITH THE INDEFLATOR, RESULTING IN THE REPORTED LEAK NOTED DURING PREPARATION; HOWEVER THIS COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE PROMUS SDS WAS NOT PREPARED FOR USE OUTSIDE OF THE PATIENT ANATOMY. THE PROMUS INSTRUCTIONS FOR USE STATES TO PREPARE AN INFLATION DEVICE WITH THE RECOMMENDED CONTRAST MEDIUM ACCORDING TO THE MANUFACTURES INSTRUCTIONS. EVACUATE AIR FROM THE BALLOON SEGMENT USING A SYRINGE OR THE INFLATION DEVICE PRIOR TO ADVANCING THE SDS INTO THE PATIENT ANATOMY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS DURING MANUFACTURE BEFORE RELEASE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AGE AT TIME OF EVENT: PATIENT AGE IS ESTIMATED; ACTUAL REPORTED AGE IS 18+. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT 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 LEFT ANTERIOR DESCENDING ARTERY, POST ABLATION WITH A 1.5MM ROTABLATOR, THE 2.5 MM X 28 MM PROMUS STENT WAS POSITIONED AND AIR EVACUATION WITH NEGATIVE PRESSURE WAS PERFORMED IN THE ANATOMY; IT WAS NOTED THAT THE BALLOON HAD A HOLE [LEAK]. IT WAS SUSPECTED THAT THE BALLOON CAME IN CONTACT WITH PLAQUE/CALCIFICATION IN THE VESSEL. IT WAS NOTED THAT RESISTANCE WAS MET DURING ADVANCEMENT AND DURING REMOVAL OF THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE DEVICE WAS REMOVED AND A SECOND SAME SIZE DEVICE WAS USED IN THE PROCEDURE. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 1020841

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR