BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 2467793 · Received February 24, 2012

    Report

    Report Number
    9616099-2012-00112
    Event Type
    Death
    Date Received
    February 24, 2012
    Date of Event
    March 1, 2000
    Report Date
    February 2, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BUKHARI ET AL IN BILATERAL RENAL ARTERY STENT INFECTION AND PSEUDOANEURYSM FORMATION; J VASC INTERV RADIOL. 2000 MAR;11(3):337-41; THE ARTICLE DESCRIBES A REPORT OF DEATH SECONDARY TO BILATERAL INFECTED RENAL ARTERY PSEUDOANEURYSM AFTER PLACEMENT OF BILATERAL RENAL ARTERY STENTS. ACCORDING TO THE ARTICLE, THE PATIENT BECAME SEPTIC FIVE MONTHS AFTER PLACEMENT OF TWO PALMAZ STENTS. THE CAUSE OF THE INFECTION WAS FROM A DIALYSIS GRAFT THAT WAS PLACED TWO MONTHS AFTER THE RENAL STENTS WERE PLACED. SUBSEQUENTLY, HER GRAFT WAS REMOVED AND HER CLINICAL STATUS STABILIZED AFTER BEING TREATED WITH VANCOMYCIN AND GENTAMICIN. A MONTH AFTER, THE PATIENT RETURNED WITH BACK PAIN AND HYPERTENSIVE CRISIS. THE PATIENT HAD A LEUKOCYTOSIS OF 20,100, AND WAS ADMITTED TO THE INTENSIVE CARE UNIT AND GIVEN ANTIHYPERTENSIVE DRIPS. AN EMERGENT ABDOMINAL COMPUTED TOMOGRAPHIC (CT) SCAN WAS OBTAINED, AND THIS REVEALED BILATERAL PSEUDOANEURYSMS OF THE RENAL ARTERIES. THE PSEUDOANEURYSMS INVOLVED THE BILATERAL PALMAZ STENTS THAT HAD BEEN PREVIOUSLY PLACED. ON THE RIGHT, THE RENAL ARTERY WAS SEEN TO BE OCCLUDED SINCE THE PREVIOUS CT SCAN DONE DURING THIS ADMISSION. IN ADDITION, THE RIGHT RENAL STENT HAD MIGRATED AND HAD BECOME VERTICAL WITHIN THE PSEUDOANEURYSM, REPRESENTING A CHANGE IN POSITION WHEN COMPARED WITH THE ABDOMINAL FILMS FROM THE PREVIOUS ADMISSION. HOWEVER, THE PATIENT'S CONDITION WORSENED AND SHE BECAME CRITICALLY UNSTABLE REQUIRING RESUSCITATION AND VASOPRESSORS. HER CLINICAL PICTURE WAS CONSISTENT WITH SEPTIC SHOCK. THE ARTICLE STATES THAT THE DIALYSIS GRAFT WAS INSERTED IN ANTICIPATION OF THE NEED FOR HEMODIALYSIS. THERE WAS NO TEMPORARY CATHETER PLACED AT THIS TIME. THREE MONTHS LATER, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH FEVER, TACHYCARDIA, AND TACHYPNEA AND A CLINICAL PICTURE OF GRAFT SEPSIS. PRIOR TO THIS PRESENTATION, THE PATIENT HAD BEEN UNDERGOING DIALYSIS FOR 6 WEEKS. ON EXAMINATION, SHE HAD PURULENT EXUDATE FROM THE DISTAL INCISION OF HER GRAFT. THE PATIENT EXPIRED APPROXIMATELY 18 HOURS AFTER ADMISSION. HISTOLOGICAL ANALYSIS OF THE STENTS AND SURROUNDING TISSUE REVEALED MARKED PERSISTENT INFLAMMATION, CONSISTENT WITH BACTERIAL INFECTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. AS STATED IN THE ARTICLE, THE CAUSE OF THE INFECTION WAS FROM A DIALYSIS GRAFT THAT WAS PLACED TWO MONTHS AFTER THE RENAL STENTS WERE PLACED. THE INFECTED STENTS MAY HAVE BEEN THE CAUSE OF THE PSEUDOANEURYSM. A PSEUDOANEURYSM, OR FALSE ANEURYSM, IS AN ENLARGEMENT OF ONLY THE OUTER LAYER OF THE BLOOD VESSEL WALL. A FALSE ANEURYSM MAY BE THE RESULT OF A PRIOR SURGERY OR TRAUMA. SOMETIMES, A TEAR CAN OCCUR ON THE INSIDE LAYER OF THE VESSEL RESULTING IN BLOOD FILLING IN BETWEEN THE LAYERS OF THE BLOOD VESSEL WALL CREATING A PSEUDOANEURYSM. CASES OF INFECTED PSEUDOANEURYSM FORMATION ARE VERY RARE AFTER STENT PLACEMENT AND THE OCCURRENCE OF AN ANEURYSM IS UNPREDICTABLE. MOST CASES REPORTEDLY OCCUR EARLY (<2 WEEKS) AFTER STENT PLACEMENT, SUGGESTING A FAILURE IN STERILE TECHNIQUE AS THE LEADING CAUSATIVE FACTOR. CAUSES OF PSEUDOANEURYSM FORMATION REPORTEDLY INCLUDE FRACTURE OF THE STENT, DISSECTION OF THE VESSELS, WALL INSTABILITY, AND INFECTION OF THE STENT. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL AND LESION. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORTS # 9616099-2012-00112 AND 9616099-2012-00113.

    Additional Manufacturer Narrative · 1

    HOWEVER, THE PATIENT'S CONDITION WORSENED AND SHE BECAME CRITICALLY UNSTABLE REQUIRING RESUSCITATION AND VASOPRESSORS. HER CLINICAL PICTURE WAS CONSISTENT WITH SEPTIC SHOCK. THE ARTICLE STATES THAT THE DIALYSIS GRAFT WAS INSERTED IN ANTICIPATION OF THE NEED FOR HEMODIALYSIS. THERE WAS NO TEMPORARY CATHETER PLACED AT THIS TIME. THREE MONTHS LATER, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH FEVER, TACHYCARDIA, AND TACHYPNEA AND A CLINICAL PICTURE OF GRAFT SEPSIS. PRIOR TO THIS PRESENTATION, THE PATIENT HAD BEEN UNDERGOING DIALYSIS FOR 6 WEEKS. ON EXAMINATION, SHE HAD PURULENT EXUDATE FROM THE DISTAL INCISION OF HER GRAFT. THE PATIENT EXPIRED APPROXIMATELY 18 HOURS AFTER ADMISSION. HISTOLOGICAL ANALYSIS OF THE STENTS AND SURROUNDING TISSUE REVEALED MARKED PERSISTENT INFLAMMATION, CONSISTENT WITH BACTERIAL INFECTION. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00112 AND 9616099-2012-00113.

    Description of Event or Problem · 1

    BUKHARI ET AL IN BILATERAL RENAL ARTERY STENT INFECTION AND PSEUDOANEURYSM FORMATION; J VASC INTERV RADIOL. 2000 MAR;11(3):337-41; THE ARTICLE DESCRIBES A REPORT OF DEATH SECONDARY TO BILATERAL INFECTED RENAL ARTERY PSEUDOANEURYSM AFTER PLACEMENT OF BILATERAL RENAL ARTERY STENTS (PALMAZ / CORDIS). ACCORDING TO THE ARTICLE THE PATIENT BECAME SEPTIC FIVE MONTHS AFTER PLACEMENT OF TWO PALMAZ STENTS. THE CAUSE OF THE INFECTION WAS FROM A DIALYSIS GRAFT THAT WAS PLACED TWO MONTHS AFTER THE RENAL STENTS WERE PLACED. SUBSEQUENTLY HER GRAFT WAS REMOVED AND HER CLINICAL STATUS STABILIZED AFTER BEING TREATED WITH VANCOMYCIN AND GENTAMICIN. A MONTH AFTER, THE PATIENT RETURNED WITH BACK PAIN AND HYPERTENSIVE CRISIS. THE PATIENT HAD A LEUKOCYTOSIS OF 20,L00, AND WAS ADMITTED TO THE INTENSIVE CARE UNIT AND GIVEN ANTIHYPERTENSIVE DRIPS. AN EMERGENT ABDOMINAL COMPUTED TOMOGRAPHIC (CT) SCAN WAS OBTAINED, AND THIS REVEALED BILATERAL PSEUDOANEURYSMS OF THE RENAL ARTERIES. THE PSEUDOANEURYSMS INVOLVED THE BILATERAL PALMAZ STENTS THAT HAD BEEN PREVIOUSLY PLACED. ON THE RIGHT, THE RENAL ARTERY WAS SEEN TO BE OCCLUDED SINCE THE PREVIOUS CT SCAN DONE DURING THIS ADMISSION. IN ADDITION, THE RIGHT RENAL STENT HAD MIGRATED AND HAD BECOME VERTICAL WITHIN THE PSEUDOANEURYSM, REPRESENTING A CHANGE IN POSITION WHEN COMPARED WITH THE ABDOMINAL FILMS FROM THE PREVIOUS ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| L| R