BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 771182 · Received October 16, 2006

    Report

    Report Number
    3004742046-2006-00424
    Event Type
    Injury
    Date Received
    October 16, 2006
    Date of Event
    September 20, 2006
    Report Date
    September 20, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:QUALITY ASSURANCE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE ABSOLUTE WAS RETURNED WITH BLOOD VISIBLE THROUGHOUT THE SHAFT. THE STENT HAD BEEN DEPLOYED AND WAS NOT RETURNED. THE DISTAL OUTER MEMBER (SHEATH) WAS SEPARATED FROM THE OUTER MEMBER AT THE PROXIMAL JUNCTION AND WAS WRINKLED AND FOLDED ONTO ITSELF. THE DISTAL OUTER MEMBER WAS OVERLAPPING THE SOFT WHITE CATHETER TIP. THE HANDLE WAS RETURNED IN THE LOCKED POSITION. THERE WAS NO OTHER DAMAGE ON THE CATHETER TO REPORT. THE HANDLE WAS OPENED AND IT WAS VERIFIED THAT ALL INTERNAL MECHANISMS WERE INTACT AND IN PROPER POSITION. THE GEAR RACK HAD NOT BEEN RETRACTED AND WAS LOCATED AT THE DISTAL END OF THE HANDLE. QUALITY ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICES. THE IMAGES SUBMITTED TO ABBOTT WERE REVIEWED BY CLINICAL WHO INDICATED THAT THE "ABSOLUTE STENTS WERE PLACED IN AN UNINTENDED SITE, WITH THE OVERLAPPING STENT MARKERS NOT WELL ORDERED". THE CATHETER WAS RETURNED WITH A DAMAGED DISTAL OUTER MEMBER (OM). THE DISTAL OM WAS SEPARATED AT THE PROXIMAL JUNCTION, WRINKLED, AND FOLDED ONTO ITSELF. THE SEPARATED OM MIGRATED DISTALLY OVERLAPPING THE SOFT WHITE TIP. THE SEPARATED DISTAL OM FROM THE PROXIMAL JUNCTION IS DUE TO MECHANICAL DAMAGE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, THE COMPLAINT DID INDICATE THAT RESISTANCE WAS FELT DURING INSERTION INTO THE INTRODUCER SHEATH WITH THE FIRST ABSOLUTE CATHETER. ALTHOUGH NO RESISTANCE WAS REPORTED WITH INTRODUCTION OF THE SECOND CATHETER, THE FAILURE MODE OBSERVED FROM THE RETURNED UNIT EMULATED SIMILAR UNITS THAT ENGINEERING HAS BENCH TESTED USING A ANGLED INSERTION INTO AN (6FR) INTRODUCTER SHEATH. THE REUSULTS OF THIS TEST INDICATED THAT THE DISTAL OUTER MEMBER CAN SEPARATE FROM THE PROXIMAL JUNCTION AND FOLD OVER ONTO THE DISTAL OM. THIS CAN LEAD TO AN EXPOSED DISTAL END OF THE STENT. NO SPECIFIC ROOT CAUSE COULD BE DETERMINED FROM THE RETURNED UNITS. ENGINEERING WILL CONTINUE TO MONITOR FOR THIS TYPE OF COMPLAINT. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. THE CONCLUSIVE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. THE PRODUCT AND IMAGES OF THE CASE WERE NOT RETURNED/SENT TO ABBOTT FOR FAILURE MODE ANALYSIS AND CONFIRMATION, AND LIMITED INFORMATION WAS PROVIDED WITH THE COMPLAINT. DURING MANUFACTURING, ALL CATHETER ARE 100% INSPECTED FOR SHAFT INTEGRITY AND RETRACTABLE SHEATH MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT EXTERNAL ILIAC STENTING PROCEDURE, THERE WERE DEPLOYMENT PROBLEMS WITH TWO ABSOLUTE STENTS. THE RIGHT EXTERNAL ILIAC LESION WAS NOT TORTUOUS AND NON-CALCIFIED. AN IPSILATERAL APPROACH WAS USED AND THE LESION WAS NOT PRE-DILATED. THE PREP PROCEDURE WENT WELL AND THE LESION WAS NOT PRE-DILATED. THE FIRST SDS (LOT# 6060752) WAS ADVANCED OVER A 0.035 NON-ABBOTT GUIDEWIRE, THROUGH A 6 FRENCH INTRODUCER SHEATH WHEN RESISTANCE WAS ENCOUNTERED AT THE DISTAL TIP OF THE SHEATH (PROXIMAL TO LESION). THE PHYSICIAN CONTINUED TO ADVANCE THE SDS AND THE STENT PREMATURELY, FULLY DEPLOYED AFTER EXITING 10 MM OUT OF THE SHEATH, WHILE THE HANDLE WAS IN LOCKED POSITION. REPORTEDLY, ON ANGIOGRAM, THE STENT APPEARED TO HAVE ACCORDIONED TO 20 MM, HALF IT'S SIZE. THE STENT DEPLOYED PROXIMAL TO THE TARGET LESION. THE SDS WAS REMOVED AND INTENTIONALLY MANIPULATED BY THE PHYSICIAN IN AN ATTEMPT TO ASSESS THE INCIDENT. THE SDS WAS DISCARDED. THE PHYSICIAN THEN INSERTED A SECOND ABSOLUTE SDS (LOT# 6062651) INTO A 6 FRENCH INTRODUCER SHEATH AND THROUGH THE FIRST ACCORDIONED STENT WHEN THE SECOND STENT PREMATURELY, FULLY DEPLOYED JUST SHORT OF THE TARGET LESION, WHILE THE HANDLE WAS IN LOCKED POSITION. AFTER REMOVAL FROM THE BODY, THE PHYSICIAN INSPECTED AND INTENTIONALLY MANIPULATED THE SDS, TRYING TO ASSESS THE PROBLEM. ON INSPECTION OF THIS LATTER DEVICE, THE PHYSICIAN NOTICED THAT THE SHORT JACKET COVERING THE STENT WAS NO LONGER GLUED TO THE OUTER SHEATH AND WOULD SLIDE FREELY ALONG THE SHAFT. THE SECOND SDS WAS RETURNED FOR ANALYSIS. A NON-ABBOTT BALLOON EXPANDABLE STENT WAS ULTIMATELY INSERTED AND DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED INJURY AND NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM MAF GUIDANT ENDOVASCULAR SOLUTIONS NA 6060752

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R PART #1010559-40, LOT #6062651| SHEATH: 6 FRENCH| GUIDE WIRE: .035 BOSTON SCIENTIFIC| ABSOLUTE .035 SELF EXPANDING STENT SYSTEM