BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 3199526 · Received July 1, 2013

    Report

    Report Number
    1016427-2013-00090
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 1, 2012
    Report Date
    June 5, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ALL-IN-ONE BALLOON SHEATH CATHETER (NUMED INC., (B)(4)). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A LITERATURE REVIEW, THE FOLLOWING ABSTRACT WAS FOUND. PLEASE NOTE THAT THE FULL ARTICLE IS NOT AVAILABLE AT THIS TIME. THE ARTICLE DESCRIBES A NOVEL METHOD OF STENT DELIVERY THAT ELIMINATES STENT SLIPPAGE USING A FRONT LOADED STENT-IN-SHEATH DELIVERY SYSTEM. THE STENTS (N58) WERE DELIVERED UNDER GA TO RELIEVE PULMONARY ARTERY STENOSES OR PRIOR TO PULMONARY VALVE REPLACEMENTS (N56). INITIALLY, USING A CONVENTIONAL BALLOON-IN-BALLOON CATHETER, A PALMAZ P4010 STENT SLIPPED OFF THE BALLOON COMPLETELY AS IT WAS ADVANCED THROUGH THE SHEATH IN THE RIGHT VENTRICULAR. THE STENT WAS RETRIEVED AND REMOUNTED ON THE BALLOON OF AN ALL-IN-ONE BALLOON SHEATH CATHETER (NUMED INC., (B)(4)). THE STENT, FRONT LOADED ON THE BALLOON (10-18 MM), COVERED BY THE SHEATH, PERMITTED MOVEMENT OF THE STENT-IN-SHEATH AS ONE SYSTEM. THE PROCEDURE WAS REPEATED IN OTHERS WITH PULMONARY ARTERY STENOSIS. RESULTS: MULTIPLE ARRHYTHMIAS OCCURRED DURING THE PASSAGE OF THE STENT-IN-SHEATH THROUGH THE RV, BUT THERE WAS NO MYOCARDIAL OR VASCULAR INJURY. SIGNIFICANT FRICTION WAS ENCOUNTERED DURING THE STENTS' PASSAGE THROUGH THE RV AND STENOTIC PULMONARY VALVE. DESPITE SIGNIFICANT FORCE USED TO ADVANCE THE STENT-IN-SHEATH THROUGH THE RV AND INTO THE PULMONARY ARTERY, THE STENTS REMAINED ON THE BALLOON, AND WAS DEPLOYED UNEVENTFULLY CONCLUSION: USING THE FRONT-LOADED ALL-IN-ONE BALLOON SHEATH CATHETER, STENT SLIPPAGE OFF THE BALLOON IS ELIMINATED. THE PROCEDURAL TIME IS SHORTENED, AND MORBIDITY REDUCED. THIS SHOULD BE THE DEVICE OF CHOICE IN STENTING STENOSES. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. STENT SLIPPAGE OR DISLODGEMENT IS A KNOWN PROCEDURAL COMPLICATION ASSOCIATED WITH ADVANCING AND IMPLANTING STENTS. ARRHYTHMIAS ARE COMMON ADVERSE EVENTS ASSOCIATED WITH ANY PROCEDURE THAT INVOLVES INTRODUCING DEVICES INTO THE HEART. THE IFU INSTRUCTS TO USE AN APPROPRIATELY SIZED CATHETER SHEATH INTRODUCER WITH AN INTRODUCER TUBE TO PREVENT DISLODGEMENT OF THE DEVICE. WHILE KEEPING THE CSI IMMOBILE, OBSERVE FLUOROSCOPICALLY AS THE STENT IS ADVANCED THROUGH THE CSI TO THE SITE OF THE LESION. CAUTION: IF EXCESSIVE RESISTANCE IS ENCOUNTERED, DO NOT FORCE PASSAGE. UNDER FLUOROSCOPY, USE THE BALLOON MARKER BANDS AND THE RADIOPAQUE STENT TO POSITION THE STENT CENTRALLY WITHIN THE LESION. DURING POSITIONING, VERIFY THAT THE STENT IS STILL CENTERED WITHIN THE BALLOON MARKER BANDS AND HAS NOT BEEN DISLODGED. PRIOR TO STENT EXPANSION, ENSURE THAT STENT AND BALLOON ARE COMPLETELY EXPOSED FROM THE CSI OR GUIDING CATHETER. NEVER RE-ADVANCE A CSI OR GUIDING CATHETER OVER AN EXPOSED STENT TO AVOID DISLODGING THE STENT. REVIEW OF THE LIMITED INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS; THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, THE FOLLOWING ABSTRACT WAS FOUND. PLEASE NOTE THAT THE FULL ARTICLE WAS NOT AVAILABLE AT THIS TIME. COE ET AL ELIMINATING STENT SLIPPAGE USING A COMBINED SHEATH-BALLOON CATHETER; CARDIOLOGY IN THE YOUNG. CONFERENCE: (B)(6). REPORT WHILE USING A CONVENTIONAL BALLOON-IN-BALLOON CATHETER, A PALMAZ P4010 STENT SLIPPED OFF THE BALLOON COMPLETELY AS IT WAS ADVANCED THROUGH THE SHEATH IN THE RIGHT VENTRICULAR. THE STENT WAS RETRIEVED AND REMOUNTED ON THE BALLOON OF AN ALL-IN-ONE BALLOON SHEATH CATHETER (NUMED INC., (B)(4)). THE STENT, FRONT LOADED ON THE BALLOON (10-18 MM), COVERED BY THE SHEATH, PERMITTED MOVEMENT OF THE STENT-IN-SHEATH AS ONE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297735 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1