BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1081997 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00585
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE STENT DELIVERY SYSTEM WAS STUCK FIRMLY IN THE GUIDE CATHETER. THE DISTAL BALLOON WAS BUNCHED AGAINST THE TIP OF THE GUIDE AND COULD NOT BE WITHDRAWN FULLY INTO THE GUIDE CATHETER. DURING THE LATER ATTEMPT TO WITHDRAW THE SDS THROUGH THE GUIDE CATHETER IT WAS DISCOVERED THAT THE GUIDE CATHETER TIP HAD FOLDED IN ON ITSELF, MOST LIKELY AS A RESULT OF THE PHYSICIAN TRYING TO PULL THE PARTIALLY DEFLATED BALLOON BACK INTO THE GUIDE CATHETER. THE SDS WAS PARTIALLY PULLED DISTALLY FROM THE GUIDE CATHETER AND THE GUIDE CATHETER TIP WAS MANIPULATED BACK OUT. A VACUUM WAS PULLED ON THE DEVICE IN AN EFFORT TO FURTHER DEFLATE THE BALLOON AND ONLY THEN COULD THE DEVICE BE WITHDRAWN FROM THE GUIDE CATHETER. THE CATHETER WAS THEN INSPECTED AND THERE WERE NO STRETCHED BONDS NOTED ON THE DEVICE. THE CATHETER SHAFT WAS KINKED. THE 0.014" GUIDEWIRE WAS STILL INSERTED IN THE DEVICE AND COULD BE MOVED PROXIMALLY AND DISTALLY WITH SOME RESISTANCE NOTED. HARDENED BLOOD WAS FOUND ON THE GUIDE WIRE, WHEN THIS WAS REMOVED, NO RESISTANCE WAS NOTED IN MOVING THE WIRE THROUGH THE INNER LUMEN. THE DEVICE WAS THEN INFLATED WITH NO ISSUES NOTED AND HELD A PRESSURE OF 9 ATMS. A DEFLATION TIME WAS RECORDED WHICH WAS WELL WITHIN THE DESIRED DEFLATION TIME, WHICH ALSO INDICATED THAT THE KINKS IN THE SHAFT DID NOT IMPACT ON THE DEFLATION OF THE DEVICE. THE SDS WAS RE-INSERTED INTO THE GUIDE CATHETER, INFLATED WITH NO ISSUES NOTED AND A DEFLATION TIME WITHIN DESIRED TIME WAS ACHIEVED. AN ATTEMPT WAS MADE TO LOAD A 0.014" MANDREL INTO THE DEVICE THROUGH THE LUER; THIS ATTEMPT FAILED AS THE MANDREL COULD NOT PASS THE KINKED AREA. THE CATHETER WAS CUT IN TWO JUST PROXIMAL TO THE JACKET BOND AND A 0.014" FLOPPY WIRE WAS LOADED SUCCESSFULLY DISTALLY THROUGH THE HYPOTUBE AND EXITED OUT OF THE LUER, INDICATING THAT THERE WERE NO PATENCY ISSUES WITH THE DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO DIFFICULTIES WERE ENCOUNTERED DURING THE DELIVERY OR INFLATION OF THE DEVICE. DEFLATION DIFFICULTIES WERE EXPERIENCED DIRECTLY AFTER THE FIRST INFLATION.

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED IN A PT FOR TREATMENT OF A RIGHT CORONARY ARTERY LESION. VESSEL MORPHOLOGY WAS NOT REPORTED. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT THE DEVICE WAS INSERTED TO THE LESION SITE; UPON DEFLATION OF THE BALLOON THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN COULD NOT WITHDRAW THE BALLOON BACK INTO THE CATHETER; THE SDS AND THE GUIDE CATHETER HAD TO BE REMOVED AS ONE UNIT. THE PT IS REPORTED TO BE STABLE AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000684854

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK