BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2914533 · Received January 14, 2013

    Report

    Report Number
    3004742232-2013-00001
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OAD WAS RECEIVED WITH THE ORIGINAL GUIDE WIRE ENGAGED IN THE DEVICE. THE DRIVESHAFT, GUIDE WIRE, AND SALINE SHEATH WERE DETACHED JUST DISTAL TO THE DISTAL STRAIN RELIEF. A DETACHED DRIVESHAFT SEGMENT WAS RETURNED SEPARATELY WITH A PORTION OF THE GUIDE WIRE ENGAGED. THE DISTAL SEGMENT OF THE SALINE SHEATH WAS RETURNED SEPARATE FROM THE DRIVESHAFT. EXAMINATION OF THE DETACHED DRIVESHAFT SECTION REVEALED A SECTION OF THE SHAFT TO BE SEVERELY COILED AND STRETCHED. THE CROWN AND TIP BUSHING WERE FOUND TO HAVE BEEN DESTRUCTIVELY REMOVED FROM THE DRIVESHAFT. THE CROWN AND TIP BUSHING SECTION WAS NOT RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT THE ADDITIONAL CASE DETAILS STATE, "THE DEVICE WAS EVALUATED BY THE PATHOLOGY DEPT., BUT ANALYSIS MAY HAVE REQUIRED THAT THEY CUT THE CROWN FROM THE REST OF THE SHAFT." AS THIS SECTION OF THE DRIVESHAFT WAS NOT RETURNED FOR ANALYSIS IT COULD NOT BE DETERMINED IF IT WAS DAMAGE OR IF IT CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. MICROSCOPIC EXAMINATION OF THE DRIVESHAFT SECTION REVEALED THE GUIDE WIRE SPRING TIP TO BE LODGED WITHIN THE DRIVESHAFT FILARS LOCATED JUST PROXIMAL TO THE CUT SECTION OF THE DRIVESHAFT SECTION. THE GUIDE WIRE SPRING TIP WAS DESTRUCTIVELY REMOVED FROM THE DRIVESHAFT FILARS. EXAMINATION OF THE SPRING TIP REVEALED THE SPRING TIP COILS TO BE SEVERELY STRETCHED DISTALLY AND THAT THE SUPPORT RIBBON AND CORE WIRE WERE FRACTURED. FURTHER EXAMINATION REVEALED THAT THE PROXIMAL SOLDER BOND REMAINED INTACT AND EXHIBITED DAMAGE CONSISTENT WITH COMING INTO CONTACT WITH THE DRIVESHAFT TIP BUSHING. THE SPRING TIP FRACTURE AND SOLDER BOND MATERIAL WAS SENT FOR SEM ANALYSIS. EXAMINATION OF THE REMAINING GUIDE WIRE DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SIGNIFICANT RESISTANCE WAS MET WHEN REMOVING THE REMAINING GUIDE WIRE SECTION FROM THE OAD. EXAMINATION OF THE GUIDE WIRE REVEALED TWO SHAFT KINKS THAT WERE LOCATED WITHIN THE HANDLE ASSEMBLY. THIS SECTION OF THE GUIDE WIRE WAS SENT FOR SEM ANALYSIS. NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED WITH THE DEVICE OR ITS COMPONENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION THE COMPLAINT OF "DEVICE CAME TO A HALT AND GOT STUCK, RIPPED ARTERY" COULD NOT BE CONFIRMED. THE CROWN AND DISTAL SEGMENT OF THE DRIVESHAFT WERE NOT RETURNED FOR ANALYSIS. FAILURE ANALYSIS REVEALED THE GUIDE WIRE SPRING TIP TO BE LODGED WITHIN THE DRIVESHAFT FILARS LOCATED JUST PROXIMALLY FROM THE DISTAL END OF THE RETURNED DRIVESHAFT SECTION. THERE WERE LONGITUDINAL DRAG MARKS IN THE SOLDER BOND MATERIAL AND THE LACK OF SPIN DAMAGE ACROSS THE SOLDER BOND AND ADJACENT SPRING TIP COILS INDICATING THE TIP BUSHING HAD NOT BEEN SPUN INTO/OVER THE SPRING TIP. THE DAMAGE IS CONSISTENT WITH THE SPRING TIP HAVING BEEN PULLED INTO THE DRIVESHAFT. THERE WERE ALSO TWO KINKS ON THE GUIDE WIRE SHAFT LOCATED WITHIN THE HANDLE ASSEMBLY. THE GUIDE WIRE AND DRIVESHAFT APPEARED TO HAVE BEEN PULLED TO FRACTURE JUST DISTAL FROM THE HANDLE. THE EXACT ROOT CAUSE OF THE GUIDE WIRE AND DRIVESHAFT DAMAGE COULD NOT BE DETERMINED, BUT APPEARS TO HAVE BEEN THE RESULT OF HANDLING OR MANIPULATING THE DEVICE DURING REMOVAL FROM THE PATIENT, ALTHOUGH THIS IS INCONCLUSIVE. ALSO, AS THIS DEVICE WAS SENT TO THE PATHOLOGY DEPARTMENT FOR ANALYSIS, THE EXACT CONDITION OF THE DEVICE PRIOR TO ITS RETURN TO CSI FOR ANALYSIS IS UNKNOWN. IT CANNOT BE DETERMINED IF THE DEVICE WAS MODIFIED IN ANY WAY SUCH THAT IT WOULD HAVE AFFECTED OUR ABILITY TO DETERMINE AN EXACT ROOT CAUSE OF THE REPORTED FAILURE. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS DEVICE LOT NUMBER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS DEVICE LOT NUMBER. THIS WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS. THE DEVICE IS CURRENTLY RETAINED BY RISK MANAGEMENT AT THE FACILITY. THE RETURN OF THE DEVICE HAS BEEN REQUESTED, BUT AT THE TIME OF THIS REPORT HAS NOT YET BEEN RECEIVED. IF IT IS RETURNED TO CSI AT SOME POINT IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE CREATED WITH THE FAILURE ANALYSIS FINDINGS. CSI (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, WHILE SPINNING IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY, THE CROWN BECAME STUCK IN THE VESSEL, REQUIRING SURGICAL INTERVENTION IN THE FORM OF A CUT-DOWN PROCEDURE TO REMOVE THE DEVICE, AS WELL AS BYPASS SURGERY TO REPAIR THE VESSEL. THE PT ARTERY AND TPT WERE TREATED WITH ORBITAL ATHERECTOMY FOLLOWED BY ANGIOPLASTY WITH EXCELLENT RESULTS. WHEN TREATMENT OF THE RIGHT DP ARTERY STENOSIS WAS ATTEMPTED, THE DEVICE WAS ADVANCED JUST ABOVE THE LEVEL OF THE ANKLE AND WAS TURNED ON, BUT IMMEDIATELY STOPPED. THE VIPERWIRE MOVED THROUGH THE OAD EASILY, BUT THE DEVICE SEEMED TO BE LODGED. USING SLOW, STEADY TENSION THE DEVICE WAS PULLED BACK TO APPROXIMATELY MID-CALF, BUT NO FURTHER. ANGIOGRAPHY CONFIRMED FLOW THROUGH THE PROXIMAL AT ARTERY, BUT TAPERED AFTER THE PROXIMAL THIRD AND WAS NOT VISUALIZED. THE DISTAL PT, TPT, PT AND PERONEAL ARTERIES WERE VISUALIZED WITHOUT SIGNIFICANT ABNORMALITY. SEVERAL TECHNIQUES WERE ATTEMPTED IN ORDER TO REMOVE THE OAD, BUT NONE WERE SUCCESSFUL. AFTER CONSULTATION WITH THE VASCULAR SURGEON, ADDITIONAL TENSION WAS APPLIED TO THE OAD WITH REMOVAL OF THE DEVICE TO THE DISTAL POP ARTERY. ANGIOGRAPHY DEMONSTRATED OCCLUSION OF THE POP ARTERY ABOVE THE LEVEL OF THE KNEE JOINT WITH EXTRAVASATION IN THE POP SPACE BELOW THE KNEE. DUE TO SUSPICION OF AT ARTERY AND DISTAL POP ARTERY AVULSION, PRESSURE WAS APPLIED AND THE VASCULAR SURGEON AGAIN CONTACTED. THE PATIENT REMAINED STABLE AND WAS TRANSFERRED TO THE OPERATING ROOM. FOLLOWING CUT-DOWN, THE OAD AND BUDDY WIRE WERE NOTED OUTSIDE OF THE LUMEN OF THE ARTERY. THE AT ARTERY WAS COMPLETELY AVULSED AND INTUSSUSCEPTED ONTO THE OAD CATHETER AND THE POP ARTERY WAS DISRUPTED FROM THE TRIFURCATION VESSELS UP TO THE MID POP ARTERY. THE DEVICES WERE REMOVED AND THE DISTAL TRIFURCATION VESSELS COULD NOT BE RECONSTRUCTED DUE TO THE SEVERE ATHEROSCLEROTIC CHANGES AND THE DISRUPTION. SUPERFICIAL FEMORAL-TO-POSTERIOR TIBIAL NON-REVERSE SAPHENOUS VEIN BYPASS WAS PERFORMED AS WELL AS LIGATION OF THE AVULSED TRIFURCATION. EXCELLENT PULSE WAS NOTED THROUGH THE VEIN GRAFT AND IN THE PT ARTERY POST-OP. OVER THE SEVEN DAYS FOLLOWING THE BYPASS SURGERY, THE PATIENT DEVELOPED NEW ULCERS AS WELL AS PROGRESSIVE ISCHEMIC AND GANGRENOUS CHANGES OF THE DISTAL RIGHT LOWER EXTREMITY WITH ASSOCIATED PAIN WHICH FINALLY LEAD TO RIGHT BELOW-THE-KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19952 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-125S 69880

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R