BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173513 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05097
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: BALANCE MIDDLEWEIGHT. INFLATION: BOSTON SCIENTIFIC. GUIDE CATH: JR. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CRYSTALLIZED CONTRAST (WHITE CLOUDY APPEARANCE) IN THE BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE ENTIRE LENGTH OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE PATIENT ANATOMY WAS MODERATELY TORTUOUS AND ECCENTRIC, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE INABILITY TO DEPLOY THE STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, INSUFFICIENT CRIMPING DURING MANUFACTURING, INCORRECT POSITION OF THE STENT ON THE BALLOON, BALLOON ENTRAPMENT (STICKING), A BALLOON PINHOLE OR RUPTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, CONTRAST DILUTION AND ACCESSORY DEVICE SUPPORT. TO ENSURE THAT THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION, DEPLOYED STENT OUTER DIAMETER AND UNIFORMITY OF EXPANSION. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS A NEW INDEFLATOR WAS FILLED WITH WATER AND WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 16ATMS AND THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. IT IS POSSIBLE THE ANATOMY NARROWED THE INFLATION LUMEN, CONTRIBUTING TO THE INABILITY TO DEPLOY THE STENT; HOWEVER THIS COULD NOT BE CONFIRMED. ADDITIONALLY, AS POSITIVE PRESSURE WAS APPLIED TO THE STENT, THIS WOULD HAVE THEN SLIGHTLY EXPANDED THE STENT, THEREFORE MAKING THE STENT BECOME LOOSE ON THE BALLOON AS THE STENT WAS UNABLE TO BE FULLY DEPLOYED AND FURTHER CONTRIBUTING TO THE REPORTED RESISTANCE DURING RETRACTION. FURTHER HANDLING DURING PACKAGING FOR RETURN TO ABBOTT VASCULAR RESULTED IN THE LOOSE STENT DISLODGING FROM THE BALLOON. 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 OTHER INCIDENTS REPORTED FOR DIFFICULT TO REMOVE OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING THE SDS, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE POSTERIOR DESCENDING ARTERY OF A RIGHT DOMINANT SYSTEM WITH MODERATE TORTUOSITY. THE LESION WAS PREDILATED WITH AN RX VOYAGER, AFTER WHICH SEVERAL ATTEMPTS WERE MADE TO CROSS TO THE LESION. THE SDS PARTIALLY CROSSED THE LESION, AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT, BUT THIS WAS ALSO UNSUCCESSFUL. RESISTANCE WAS FELT DURING REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PATIENT, AND THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON. DURING REMOVAL OF THE SDS FROM THE PATIENT, THE STENT WAS NOTED TO BE PARTIALLY DISLODGED AND DURING PACKAGING OF THE DEVICE FOR RETURN, THE STENT IMPLANT DISLODGED COMPLETELY FROM THE BALLOON. ANOTHER 2.25 X 15 MM XIENCE V WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0091641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR