BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS ON AMIIA

    MDR report key: 2970008 · Received February 20, 2013

    Report

    Report Number
    9616099-2013-00078
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NO INDICATED IF THERE WAS ANY DIFFICULTY CROSSING THE LESION OR ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED. IT WAS ALSO INTACT UPON REMOVAL. THERE WAS NO DIFFICULTY ADVANCING THE PRODUCT THROUGH THE VESSEL. THE BALLOON WAS INFLATED AT APPROXIMATELY 10ATM DURING THE 3-4 TIMES DILATIONS. IT IS CONSIDERED THAT THE DISSECTION WAS OCCURRED DURING THE BALLOON RUPTURE OF THE PRODUCT. CONCOMITANT DEVICES: INFLATION DEVICE: ENCORE26, GW: RUNTHROUGH, Y CONNECTOR: GOODMAN'S, STENT: PALMAZ GENESIS 6.0/15MM. DURING PTA AND STENTING OF THE RENAL ARTERY, THE BALLOON OF A PALMAZ GENESIS STENT DELIVERY SYSTEM RUPTURED AFTER 3 OR 4 INFLATIONS. AFTER THE DEVICE WAS REMOVED A DISSECTION WAS CONFIRMED WHICH REQUIRED PLACEMENT OF AN ADDITIONAL STENT. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH A 90% STENOSIS. APPROACH WAS MADE FROM THE RADIAL ARTERY, THE LESION WAS CROSSED WITH A GUIDEWIRE, THEN A 6.0X15MM PALMAZ GENESIS WAS DELIVERED TO THE LESION AND THE BALLOON OF THE PALMAZ GENESIS WAS INFLATED AT 10 ATMOSPHERES, IT WAS OBSERVED THAT THE STENT WAS NOT EXPANDED ENOUGH SO 3 TO 4 DILATIONS WERE CONDUCTED, HOWEVER, THE BALLOON RUPTURED. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND AFTERWARDS A SLIGHT DISSECTION WAS CONFIRMED. AN ADDITIONAL PALMAZ GENESIS WAS PLACED FOR TREATMENT OF THE DISSECTION AND THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15131755 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED BALLOON BURST. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING PTA AND STENTING OF THE RENAL ARTERY, THE BALLOON OF A PALMAZ GENESIS RUPTURED AND AFTER THE DEVICE WAS REMOVED A DISSECTION WAS CONFIRMED WHICH REQUIRED PLACEMENT OF AN ADDITIONAL STENT. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE % OF THE STENOSIS WAS 90%. APPROACH WAS MADE FROM THE RADIAL ARTERY, AND THE LESION WAS CROSSED WITH A GUIDEWIRE (RUNTHROUGH). THEN S 6.0X15MM PALMAZ GENESIS WAS DELIVERED TO THE LESION, AND THE BALLOON OF THE PALMAZ GENESIS WAS INFLATED AT 10ATM TO PLACE THE STENT, BUT IT WAS CONFIRMED THAT THE STENT WAS NOT EXPANDED ENOUGH, 3 TO 4 TIMES OF DILATIONS WERE CONDUCTED WITH THE BALLOON OF THE PALMAZ GENESIS. HOWEVER, THE BALLOON RUPTURED DURING THE DILATIONS, AND THE BALLOON RUPTURE WAS CONFIRMED BECAUSE THE PRESSURE OF THE INFLATION DEVICE WAS NOT INCREASED. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. AFTERWARDS, SLIGHT DISSECTION WAS CONFIRMED. THEREFORE, AN ADDITIONAL STENT (PALMAZ GENESIS 6.0/15MM) WAS PLACED FOR TREATMENT OF THE DISSECTION. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION, AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE DISSECTION OCCURRED DURING THE RUPTURE OF THE PALMAZ GENESIS BUT THE DISSECTION GRADE IS UNKNOWN. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST USED IS UNKNOWN. THE RATIO IS USUALLY 1:1. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH ANOTHER BALLOON. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73523 PALMAZ GENESIS ON AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15131755

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention