BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 3063336 · Received April 17, 2013

    Report

    Report Number
    3004742232-2013-00012
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K110389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B)(4). : DISCARDED BY FACILITY.

    Additional Manufacturer Narrative · 1

    UPDATED WITH PATIENT WEIGHT AND CORRECTED PATIENT AGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED VIA THE PATIENT'S MEDICAL RECORD AND THE USER FACILITY MEDWATCH THAT THE ORBITAL ATHERECTOMY DEVICE (OAD) HAD PERFORATED THE DISTAL LEFT POPLITEAL (POP) ARTERY AND BECAME LODGED EXTRA-LUMINALLY AT THE LEVEL OF THE JOINT IN ADJACENT SOFT TISSUE. FOLLOWING TRANSFER OF THE PATIENT FROM OAK PARK HOSPITAL, THE PATIENT WAS ADMITTED TO RUSH UNIVERSITY MEDICAL CENTER AND TAKEN TO INTERVENTIONAL RADIOLOGY FOR AN ATTEMPTED RETRIEVAL OF THE RETAINED OAD TIP. THE ATTEMPT WAS UNSUCCESSFUL, SO THE PATIENT WAS TAKEN TO THE OPERATING ROOM THE NEXT DAY FOR SURGICAL REMOVAL OF THE RETAINED OBJECT. ONCE THE POP ARTERY WAS DISSECTED, IT WAS NOTED THAT THE OAD HAD PERFORATED THROUGH THE POSTERIOR WALL OF THE OCCLUDED VESSEL AND REMAINED WITHIN THE SOFT TISSUE OF THE POP SPACE. THE DISTAL TIP OF THE OAD WAS CUT FROM THE DRIVE SHAFT AND REMOVED FROM THE BODY. THE REMAINING PORTION OF DRIVE SHAFT WAS THEN REMOVED IN ITS ENTIRETY FROM THE RIGHT GROIN SHEATH. INSPECTION OF THE POP ARTERY CONFIRMED THAT IT WAS CHRONICALLY OCCLUDED, WITH SEVERE CALCIFICATION. THERE WAS NO BLEEDING AND NO PALPABLE PULSE WITHIN THE CHRONICALLY OCCLUDED VESSEL; A STRONG PALPABLE LEFT FEMORAL PULSE WAS CONFIRMED. THE BACK WALL POP PERFORATION WAS OVER-SEWN TO PREVENT ANY MINIMAL BACK-BLEEDING FROM THE COLLATERAL VESSELS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THAT SAME DAY, A LEFT LOWER EXTREMITY ARTERIOGRAM WAS THEN PERFORMED IN INTERVENTIONAL RADIOLOGY WHICH DEMONSTRATED THROMBUS IN THE LEFT COMMON FEMORAL ARTERY (CFA). AN INFUSION CATHETER WAS PLACED ACROSS THE THROMBUS AND THROMBOLYSIS WITH TPA INFUSION AT 0.5MG/HR WAS INITIATED AND INFUSED OVERNIGHT. THE NEXT DAY, A LEFT LOWER EXTREMITY ANGIO DEMONSTRATED PERSISTENT THROMBUS/OCCLUSION OF THE LEFT CFA/SFA; PROFUNDA PATENT PROXIMALLY WITH THROMBUS AND POOR DISTAL FLOW; BELOW THE KNEE, SINGLE VESSEL PERONEAL RUNOFF TO THE ANKLE WAS EXTREMELY DELAYED. THE INFUSION CATHETER WAS REPOSITIONED IN THE PROXIMAL PROFUNDA. LATER THAT AFTERNOON, A REPEAT ANGIOGRAM DEMONSTRATED SIGNIFICANT IMPROVEMENT IN FLOW TO THE PROFUNDA, CFA/SFA. THE THROMBOLYTIC INFUSION WAS CONTINUED OVERNIGHT. THE NEXT DAY, REPEAT ANGIOGRAM DEMONSTRATED PERSISTENT COMPLETE OCCLUSION OF THE SFA; THE PROFUNDA ARTERY WAS NOW PATENT. NO DISTAL RUNOFF OR RECONSTITUTION. AN INFUSION CATHETER WAS PLACED INTO THE SFA AND CFA. THE THROMBOLYTIC INFUSION WAS CONTINUED OVERNIGHT AT 1 MG/HR. LATER THAT EVENING, THE PATIENT WAS TAKEN EMERGENTLY TO SURGERY DUE TO LEFT LOWER EXTREMITY ISCHEMIA INDICATED BY AN INCREASINGLY CYANOTIC AND COLD LEFT LEG. THE PREVIOUS INCISION WAS EXPLORED AND NO ACTIVE BLEEDING WAS FOUND; THERE WAS EVIDENCE OF HEMATOMA FROM MUSCLE AND SOFT TISSUE BLEEDING. THE MUSCLE DID NOT APPEAR VIABLE. FOUR COMPARTMENT FASCIOTOMIES WERE PERFORMED. MUSCLE IN THE ANTERIOR AND LATERAL COMPARTMENTS ALSO APPEARED COMPROMISED. BYPASS WAS NOT PERFORMED AS THERE WAS NO DISTAL TARGET FOR BYPASS DUE TO THE PATIENT'S EXTENSIVE PAD. ON HOSPITAL DAY 7, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR LEFT ABOVE-THE-KNEE AMPUTATION (AKA). THE PATIENT STATUS IMPROVED AFTER AKA AND SHE WAS DISCHARGED IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED WHICH REQUIRED SURGICAL INTERVENTION. THE LESION BEING TREATED WAS A MODERATELY TO SEVERELY CALCIFIED CTO LESION MEASURING 10CM LENGTH. THE LESION WAS LOCATED IN THE POPLITEAL (POP) ARTERY WHICH DEMONSTRATED A 4.5MM REFERENCE VESSEL DIAMETER. DISTALLY A PREVIOUSLY EXISTING BYPASS TIE-IN WAS LOCATED. THE PHYSICIAN USED A CONTRALATERAL APPROACH TO CROSS THE LESION AND PERFORMED 1 RUN AT LOW SPEED LASTING 5SEC. AS HE ADVANCED THE CROWN THE DEVICE CAME TO A HALT AND WAS LODGED IN THE LESION. THE PHYSICIAN COULD NOT PULL IT OUT. THE PHYSICIAN CAME TO THE CONCLUSION THAT THE VESSEL WALL WAS FRAGILE FROM THE PREVIOUS BYPASS SURGERY AND THAT'S WHY THE PERFORATION OCCURRED AND WHY THE OAD BECAME LODGED IN THE TISSUE. THE PATIENT WAS TRANSFERRED FROM (B)(6) HOSPITAL TO (B)(6) MEDICAL CENTER FOR SURGICAL REMOVAL OF THE DEVICE FROM THE PATIENT'S VESSEL. THE PATIENT STATUS REMAINED STABLE THROUGHOUT AND FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165381 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-150 64924

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention