BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 4323246 · Received December 11, 2014

    Report

    Report Number
    1016427-2014-00124
    Event Type
    Injury
    Date Received
    December 11, 2014
    Date of Event
    November 19, 2014
    Report Date
    January 13, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2ND STENT WAS ATTEMPTED TO BE REMOVED FROM THE SVC, SO A SHEATH INTRODUCER (14FR23CM) WAS INSERTED AND A NON-CORDIS BALLOON WAS DELIVERED INTO THE 2ND STENT. THE PHYSICIAN PUSHED THE STENT WITH THE BALLOON AND INFLATED THE BALLOON INSIDE THE 1ST STENT, HOWEVER, AT DEFLATION, THE 2ND STENT WAS MOVED BACK 2CM TO DISTAL. AS SAME WAY, ANOTHER NON-CORDIS BALLOON WAS INFLATED AND DEFLATED. BUT THE SAME ISSUE OCCURRED. IN THE END, THE 2ND STENT DISLODGED INTO RIGHT ATRIUM. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS GOING TO BE FOLLOWED UP. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: 035 RADIFOCUS GUIDEWIRE, TERUMO; MUSTANG BALLOON CATHETER, BSJ; 4/20MM MUSTANG BALLOON CATHETER, BSJ; AND 32MM CODA BALLOON CATHETER, COOK. (B)(4). (B)(6). THIS IS ONE OF TWO PRODUCTS PROBLEMS THAT OCCURRED DURING THIS PROCEDURE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2014-00124 AND 9616099-2014-00796.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS PROBLEMS THAT OCCURRED DURING THIS PROCEDURE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2014-00124 AND 9616099-2014-00796. COMPLAINT CONCLUSION: AS REPORTED, DURING TREATMENT OF A LESION IN THE INFERIOR VENA CAVA, ONE PALMAZ XL STENT DISLODGED AND ANOTHER MIGRATED FROM THE LESION. ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS A (B)(6) MALE DIAGNOSED WITH TERMINAL CANCER. THE TARGET LESION WAS THE INFERIOR VENA CAVA. THE LESION WAS NOT CALCIFIED AND MODERATELY TORTUOUS AND THE LENGTH WAS 60MM AND THE DIAMETER OF THE REFERENCE VESSEL WAS 25MM. THERE WAS 90% STENOSIS (6MM). AN APPROACH WAS MADE FROM THE RIGHT FEMORAL VEIN WITH AN UNKNOWN SHEATH INTRODUCER (8FR 65CM). AFTER LESION WAS CROSSED WITH A NON-CORDIS GUIDEWIRE, A NON-CORDIS BALLOON CATHETER WAS INFLATED. HOWEVER, RECOILING WAS CONFIRMED. THE SHEATH INTRODUCER WAS EXCHANGED TO ANOTHER ONE (14FR 60CM) AND THE PALMAZ XL WAS MOUNTED ON A 25X40MM MAXI-LD BALLOON CATHETER. THE BALLOON CATHETER WAS INSERTED AND INFLATED, HOWEVER, THE STENT SLIPPED TWO CENTIMETERS DISTALLY AND WAS PLACED ONLY ONE CENTIMETER AT THE LESION BEFORE NOMINAL PRESSURE (3.5 ATMOSPHERES). NEXT ANOTHER PALMAZ XL 20X40MM MAXI-LD BALLOON CATHETER WAS PLACED OVERLAPPING ON THE FIRST STENT WITHOUT ANY ISSUE; HOWEVER, WHILE A THE STENT WAS BEING DELIVERED, THE SECOND PALMAZ XL MIGRATED DISTAL TO THE FIRST STENT AND OVERLAPPED ONE CENTIMETER. THE GUIDEWIRE ENTANGLED ONTO THE SECOND STENT AND IT STOPPED THERE. THE SECOND STENT WAS ATTEMPTED TO BE REMOVED FROM THE SUPERIOR VENA CAVA, SO A SHEATH INTRODUCER (14FR23CM) WAS INSERTED AND A NON-CORDIS BALLOON WAS DELIVERED TO THE SECOND STENT. THE PHYSICIAN PUSHED THE STENT WITH THE BALLOON AND INFLATED THE BALLOON INSIDE THE FIRST STENT; HOWEVER, AT DEFLATION, THE 2ND STENT WAS MOVED TWO CENTIMETERS DISTALLY. ANOTHER NON-CORDIS BALLOON WAS INFLATED AND DEFLATED. BUT THE SAME ISSUE OCCURRED. IN THE END, THE SECOND STENT ¿DISLODGED¿ INTO RIGHT ATRIUM. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS GOING TO BE FOLLOWED UP. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NORMAN NOBLE PERFORMED A DOCUMENT HISTORY RECORD REVIEW OF THE BATCH RECORDS IN QUESTION NNI JOB NUMBER (B)(4) NNI LOT NUMBER N0512310 VIA NNI ERP SYSTEM. THERE WERE NO ANOMALIES FOUND AND THE PRODUCT WAS PACKAGED AND LABELLED TO ALL CORDIS SPECIFICATIONS. CONCLUSION: THE DHR REVEALED NOTHING THAT WOULD LEAD NORMAN NOBLE TO BELIEVE THAT THERE HAD BEEN ANY EVIDENCE THAT THE ROOT CAUSE WOULD HAVE DERIVED FROM NNI. ALSO, THERE WAS THE USE OF NON-CORDIS EQUIPMENT THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT. THE REPORTED ¿STENT DISLODGED¿ AND ¿STENT MIGRATION¿ OF THE TWO PALMAZ XL STENTS COULD NOT BE CONFIRMED AS THE STENTS REMAINED IMPLANTED IN THE PATIENT. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THIS EVENT; AS SUCH, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT WAS A (B)(6) MALE TERMINAL CANCER PATIENT. THE TARGET LESION WAS THE INFERIOR VENA CAVA. THE LESION WAS NOT CALCIFIED AND MODERATELY TORTUOUS AND THE LENGTH WAS 60MM AND THE DIAMETER OF THE REFERENCE VESSEL WAS 25MM. THERE WAS 90% STENOSIS (6MM). AN APPROACH WAS MADE FROM THE RIGHT FEMORAL VEIN WITH AN UNKNOWN SHEATH INTRODUCER (8FR 65CM). AFTER LESION WAS CROSSED WITH A NON-CORDIS GUIDEWIRE, A NON-CORDIS BALLOON CATHETER WAS INFLATED. HOWEVER, RECOILING WAS CONFIRMED, AND SO A 1ST PALMAZ XL WAS ATTEMPTED TO BE PLACED. THE SHEATH INTRODUCER WAS EXCHANGED TO ANOTHER ONE (14FR 60CM) AND THE PALMAZ XL WAS MOUNTED ON A 25X40MM MAXI-LD BALLOON CATHETER WAS INFLATED. HOWEVER, THE STENT SLIPPED 2CM DISTALLY AND WAS PLACED ONLY 1CM AT THE LESION BEFORE NOMINAL PRESSURE (3.5ATM). AND NEXT, A 2ND PALMAZ XL WITH A 20X40MM MAXI-LD BALLOON CATHETER WAS PLACED OVERLAPPING ON THE FIRST STENT WITHOUT ANY ISSUE AT FIRST, BUT WHILE A THIRD STENT WAS DELIVERING, THE 2ND STENT WAS MIGRATED TO DISTAL TO THE 1ST STENT AND OVERLAPPED 1CM WITH THE 1ST STENT. THE GUIDEWIRE ENTANGLED ONTO THE 2ND STENT AND IT STOPPED THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806652 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N0512310

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R