BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 3901593 · Received June 30, 2014

    Report

    Report Number
    9616099-2014-00422
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SMART CONTROL STENTS WERE STORED, INSPECTED, HANDLED, AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SDS PRIOR TO USE. THERE WAS NO DIFFICULTY ENCOUNTERED ADVANCING/TRACKING THE SDS TOWARDS THE LESION. NO UNUSUAL FORCE WAS APPLIED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS PRESENT PROXIMAL TO, AT, OR DISTAL TO THE LESION SITE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. IT IS UNKNOWN IF THE SDS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. IT IS UNKNOWN IF THE USER HELD THE HANDLE FLAT AND STRAIGHT OUTSIDE THE PATIENT, AS INSTRUCTED IN THE IFU. IT IS UNKNOWN IF THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY. IT IS UNKNOWN IF BOTH STENTS EXPANDED FULLY WITH GOOD WALL APPOSITION. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00422, 9616099-2014-00423, & 9616099-2014-00424. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00422, 9616099-2014-00423, AND 9616099-2014-00424. COMPLAINT CONCLUSION: DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE AORTA, THE PHYSICIAN DEPLOYED TWO 10X40MM SMART CONTROL STENTS BUT THE STENTS ¿JUMPED AND JAILED¿ THE LEFT RENAL ARTERY. THEREFORE, HE DILATED THE RENAL ARTERY WITH A BALLOON (NON-CORDIS) AND ATTEMPTED TO IMPLANT A 5.0X18 PALMAZ GENESIS AMIIA SDS, HOWEVER, THE DEVICE COULD NOT BE INFLATED AS THE BALLOON BURST AND LEAKAGE FROM THE BALLOON WAS OBSERVED. IT WAS ASSUMED THAT THE PALMAZ GENESIS AMIIA GOT STUCK WITH THE IMPLANTED STENT DURING DELIVERY AND IT RUPTURED. IT WAS EASILY REMOVED INTACT FROM THE PATIENT AND WAS EXCHANGED FOR ANOTHER BALLOON INSTEAD. THE PROCEDURE FINISHED SUCCESSFULLY WITHOUT STENT IMPLANTATION. THERE WAS NO PATIENT INJURY REPORTED. THE LESION WAS NOT CALCIFIED BUT MODERATELY TORTUOUS WITH 90% STENOSIS. THE SMART CONTROL STENTS WERE STORED, INSPECTED, HANDLED, AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SDS PRIOR TO USE. THERE WAS NO DIFFICULTY ENCOUNTERED ADVANCING/TRACKING THE SDS TOWARDS THE LESION. NO UNUSUAL FORCE WAS APPLIED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS PRESENT PROXIMAL TO, AT, OR DISTAL TO THE LESION SITE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. IT IS UNKNOWN IF THE SDS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. IT IS UNKNOWN IF THE USER HELD THE HANDLE FLAT AND STRAIGHT OUTSIDE THE PATIENT, AS INSTRUCTED IN THE IFU. IT IS UNKNOWN IF THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY. IT IS UNKNOWN IF BOTH STENTS EXPANDED FULLY WITH GOOD WALL APPOSITION. THE PALMAZ GENESIS STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES. PRIOR TO INSERTING THE SDS IN THE CATHETER, THE BALLOON WAS NOT INFLATED. NEGATIVE PRESSURE WAS APPLIED TO THE SDS. IT IS UNKNOWN IF THE INFLATION DEVICE WAS IN NEUTRAL POSITION WHEN THE SYSTEM WAS BEING ADVANCED/WITHDRAWN. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WAS NO PROBLEM FLUSHING THE DEVICE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. AN UNKNOWN CONTRAST MEDIA AND INFLATION DEVICE WAS USED. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL OR CROSSING THE LESION. THE DEVICE WAS NOT IN AN ACUTE BEND. THE DEVICE DID NOT KINK DURING USE. ONE NON STERILE CATHETER SDS RX GEN. AMIIA 5.0X1 WAS RECEIVED INSIDE A PLASTIC BAG. THE BALLOON WAS NOT INFLATED. THE STENT WAS RECEIVED MOUNTED ON THE BALLOON IN ORIGINAL POSITION. THE STENT WAS NOT DEPLOYED. THERE WERE BLOOD RESIDUES OBSERVED IN THE RETURNED DEVICE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. LEAK TEST COULD NOT BE PERFORMED SINCE LEAKAGE WAS OBSERVED IN THE BALLOON AT .8CM FROM DISTAL TIP END. THE DEVICE WAS SENDING AT SEM ANALYSIS TO IDENTIFY THE CAUSE OF BALLOON LEAKAGE. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS NEAR TO THE LEAKAGE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON LEAKAGE FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE DISTAL MARKER BAND EXHIBITED NO ANOMALIES. REVIEW OF LOT 15999835 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE SMART STENTS REMAINED IMPLANTED IN THE PATIENT AND THEREFORE COULD NOT BE ANALYZED. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED ¿DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. CLINICAL FACTORS CONTRIBUTING TO THE DIFFICULTY COULD NOT BE DETERMINED; HOWEVER, IT IS UNKNOWN IF, AS THE IFU ADVISES, THE USER ADVANCED THE STENT DELIVERY SYSTEM PAST THE LESION SITE AND THEN PULLED BACK THE STENT DELIVERY SYSTEM UNTIL THE RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) MOVE IN POSITION SO THAT THEY ARE PROXIMAL AND DISTAL TO THE LESION SITE. THE IFU ALSO STATES TO ¿VERIFY THAT THE DELIVERY SYSTEM¿S RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) ARE PROXIMAL AND DISTAL TO THE TARGET LESION, TO ENSURE THAT THE INTRODUCER SHEATH DOES NOT MOVE DURING DEPLOYMENT AND REMOVE THE LOCKING PIN FROM HANDLE. THEN, INITIATE ONE-HANDED STENT DEPLOYMENT BY ROTATING THE TUNING DIAL WITH THUMB AND INDEX FINGERS IN A CLOCKWISE DIRECTION (DIRECTION OF ARROW) WHILE HOLDING THE HANDLE IN A FIXED POSITION. WHILE USING FLUOROSCOPY, MAINTAIN POSITION OF THE RADIOPAQUE STENT MARKERS RELATIVE TO THE TARGETED LESION SITE. WATCH FOR THE DISTAL RADIOPAQUE MARKERS TO BEGIN SEPARATING. SEPARATION OF THE DISTAL STENT MARKERS SIGNALS THAT THE STENT IS UNSHEATHED. CONTINUE TURNING THE TUNING DIAL UNTIL THE DISTAL END OF THE STENT OBTAINS FULL APPOSITION WITH THE VESSEL WALL.¿ BASED ON THE INFORMATION AVAILABLE FOR REVIEW, AND WITHOUT A STERILE LOT NUMBER/ANALYSIS, THE REPORTED DEPLOYMENT DIFFICULTY DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS OF THE DEVICE. NO CORRECTIVE ACTION WILL BE TAKEN. THE REPORTED ¿BALLOON BURST¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE; HOWEVER, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE INFORMATION PROVIDE NOTES VESSEL CHARACTERISTICS (MODERATELY TORTUOUS WITH 90% STENOSIS) AND PROCEDURAL FACTORS (DEPLOYED STENT MAY HAVE PUNCTURED BALLOON) WHICH MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE AS EVIDENCED BY ABRASIONS NEAR LEAKAGE LOCATION. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY AND NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE AORTA, IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED TWO 10X40MM SMART CONTROL STENTS BUT THE STENTS JUMPED AND JAILED THE LEFT RENAL ARTERY. THEREFORE, HE DILATED THE RENAL ARTERY WITH A BALLOON (4MM SHIDEN, KANEKA) AND ATTEMPTED TO IMPLANT A 5.0X18 PALMAZ GENESIS AMIIA SDS, HOWEVER, THE DEVICE COULD NOT BE INFLATED. THE BALLOON BURST AND LEAKAGE FROM THE BALLOON WAS OBSERVED. THEREFORE, IT WAS EASILY REMOVED INTACT FROM THE PATIENT AND WAS EXCHANGED FOR ANOTHER BALLOON INSTEAD. THE PROCEDURE FINISHED SUCCESSFULLY WITHOUT STENT IMPLANTATION. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT (PALMAZ GENESIS) WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE LESION WAS NOT CALCIFIED AND MODERATELY TORTUOUS. THE RATE OF STENOSIS WAS 90%. THE SALES REP GUESSED THAT THE PALMAZ GENESIS AMIIA GOT STUCK WITH THE IMPLANTED STENT DURING DELIVERING AND IT RUPTURED. THE PALMAZ GENESIS STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES. PRIOR TO INSERTING THE SDS IN THE CATHETER, THE BALLOON WAS NOT INFLATED. NEGATIVE PRESSURE WAS APPLIED TO THE SDS. IT IS UNKNOWN IF THE INFLATION DEVICE WAS IN NEUTRAL POSITION WHEN THE SYSTEM WAS BEING ADVANCED/WITHDRAWN. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WAS NO PROBLEM FLUSHING THE DEVICE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. AN UNKNOWN CONTRAST MEDIA AND INFLATION DEVICE WAS USED. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL OR CROSSING THE LESION. THE DEVICE WAS NOT IN AN ACUTE BEND. THE MAXIMUM INFLATION PRESSURE IS UNKNOWN. THE DEVICE DID NOT KINK DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379247 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15993835

    Patients

    Seq Age Sex Outcome Treatment
    1 4MM SHIDEN, KANEKA BALLOON