BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 3670654 · Received March 10, 2014

    Report

    Report Number
    9616099-2014-00175
    Event Type
    Injury
    Date Received
    March 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 14, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED DURING A LITERATURE REVIEW, AN ARTICLE REPORTED THAT APPROXIMATELY FOUR WEEKS AFTER A (B)(6) PATIENT HAD AN UNKNOWN SMART CONTROL STENT IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (CIA), THE PATIENT WAS RE-ADMITTED WITH SYMPTOMS OF TENDERNESS IN THE LEFT BUTTOCK AND LEG, A WARM, SLIGHTLY SWOLLEN LEFT KNEE, AND A FEVER (T 39 DEGREES CELSIUS). ON THE VENTRAL SIDE OF HER LEG THERE WERE MULTIPLE PETECHIAE. THE INGUINAL AREA WAS UNREMARKABLE WITHOUT HEMATOMA OR LYMPHADENOPATHY AND PERIPHERAL PULSATIONS WERE PRESENT. A SEPTIC ARTHRITIS OF THE KNEE WAS EXCLUDED THROUGH A SYNOVIAL PUNCTURE BY AN ORTHOPEDIC SURGEON. AFTER TAKING BLOOD CULTURES, CLINICAL TREATMENT WITH INTRAVENOUS ANTIBIOTICS (CEFUROXIM 750 MG 3DD1, GENTAMYCIN 400 MG 1DD1) WAS STARTED. DURING ADMISSION THE DIAGNOSIS OF ENDOCARDITIS WAS EXCLUDED BY A CARDIOLOGIST VIA A TRANSTHORACIC ECHOCARDIOGRAM. THE BLOOD CULTURES SHOWED STAPHYLOCOCCUS AUREUS, AFTER WHICH THE ANTIBIOTICS WERE CHANGED TO FLUCLOXACILLIN 12G/24H. AFTER A WEEK, A PET-CT WAS PERFORMED WHICH SHOWED AN INFECTED MASS AROUND THE STENT IN THE LEFT CIA, A HYDRONEPHROSIS OF THE LEFT KIDNEY CAUSED BY OBSTRUCTION BY THE MASS AND NO SIGNS OF FURTHER INFECTION ELSEWHERE. A STANDARD CT-ANGIOGRAPHY (CTA) WAS PERFORMED, WHICH CONFIRMED A PSEUDOANEURYSM WITH CONTRAST LEAKAGE AND THE HYDRONEPHROSIS. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. MANUFACTURING RECORDS (DHR) COULD NOT BE REVIEWED, AS THE PRODUCT CATALOG AND LOT NUMBER ARE NOT AVAILABLE. THE ARTICLE NOTED THAT THE CULTURE OF THE STENT WAS STERILE, PROBABLY BECAUSE OF THE LONG TREATMENT WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS DISCHARGED FREE OF SYMPTOMS ONE (1) WEEK POSTOPERATIVELY WITH CONTINUED HOME ANTIBIOTIC TREATMENT. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING ROOT CAUSE BE DRAWN. THERE ARE POSSIBLE PATIENT, PROCEDURAL, OR HANDLING FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE OF (B)(6) 2014 IS THE ALERT DATE THAT THE ARTICLE WAS NOTED. THE DATE OF IMPLANTATION USED IS BEING REPORTED AS (B)(6) 2013 AS THE EVENT OCCURRED APPROXIMATELY FOUR WEEKS AFTER IMPLANTATION. FOLLOWING THE DIAGNOSIS OF THE INFECTED STENT, THE PATIENT WAS PLANNED FOR SURGERY. THE HYDRONEPHROSIS WAS TREATED BY AN UROLOGIST BY PLACING A DOUBLE-J URETERAL CATHETER IN THE LEFT URETER. DURING THE OPERATION, A FEMORAL-FEMORAL CROSSOVER BYPASS WAS CREATED USING A RIFAMPICIN-COATED. DACRON GRAFT, AFTER LIGATION OF THE EXTERNAL ILIAC ARTERY. AFTER INSTALLATION OF THE CROSSOVER BYPASS, THE LEFT INTERNAL ILIAC ARTERY AND THE LEFT COMMON ILIAC ARTERY WERE LIGATED AND THE EVIDENTLY INFECTED COMMON ILIAC ARTERY AND STENT WERE EXCISED. THE CULTURE OF THE STENT WAS STERILE, PROBABLY BECAUSE OF THE LONG TREATMENT WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS DISCHARGED FREE OF SYMPTOMS 1 WEEK POSTOPERATIVELY. THE INTRAVENOUS ANTIBIOTIC TREATMENT WAS CONTINUED AT HOME THROUGH A CENTRAL VENOUS CATHETER FOR ANOTHER 5 WEEKS. A CONTROL DUPLEX ULTRASOUND SHOWED A PATENT CROSSOVER BYPASS 6 WEEKS POSTOPERATIVELY, LABORATORY RESULTS SHOWED A CRP OF 3 MG/L, LEUKOCYTOSIS OF 7.3 X109/L AND A BSE OF 33 MM/H. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AN ARTICLE WAS NOTED IN THE PUBLICATION BY BOSMAN ET AL: INFECTIONS OF INTRAVASCULAR BARE METAL STENTS: A CASE REPORT AND REVIEW OF LITERATURE, EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 47(2014) 87-99. APPROXIMATELY FOUR WEEKS AFTER A (B)(6) PATIENT HAD AN UNKNOWN SMART CONTROL STENT IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (CIA), THE PATIENT WAS RE-ADMITTED WITH SYMPTOMS OF TENDERNESS IN THE LEFT BUTTOCK AND LEG, A WARM, SLIGHTLY SWOLLEN LEFT KNEE, AND A FEVER (T 39 DEGREES CELSIUS). ON THE VENTRAL SIDE OF HER LEG THERE WERE MULTIPLE PETECHIAE. THE INGUINAL AREA WAS UNREMARKABLE WITHOUT HEMATOMA OR LYMPHADENOPATHY AND PERIPHERAL PULSATIONS WERE PRESENT. A SEPTIC ARTHRITIS OF THE KNEE WAS EXCLUDED THROUGH A SYNOVIAL PUNCTURE BY AN ORTHOPEDIC SURGEON. AFTER TAKING BLOOD CULTURES, CLINICAL TREATMENT WITH INTRAVENOUS ANTIBIOTICS (CEFUROXIM 750 MG 3DD1, GENTAMYCIN 400 MG 1DD1) WAS STARTED. DURING ADMISSION THE DIAGNOSIS OF ENDOCARDITIS WAS EXCLUDED BY A CARDIOLOGIST VIA A TRANSTHORACIC ECHOCARDIOGRAM. THE BLOOD CULTURES SHOWED STAPHYLOCOCCUS AUREUS, AFTER WHICH THE ANTIBIOTICS WERE CHANGED TO FLUCLOXACILLIN 12G/24H. AFTER A WEEK, A PET-CT WAS PERFORMED WHICH SHOWED AN INFECTED MASS AROUND THE STENT IN THE LEFT CIA, A HYDRONEPHROSIS OF THE LEFT KIDNEY CAUSED BY OBSTRUCTION BY THE MASS AND NO SIGNS OF FURTHER INFECTION ELSEWHERE. A STANDARD CT-ANGIOGRAPHY (CTA) WAS PERFORMED, WHICH CONFIRMED A PSEUDOANEURYSM WITH CONTRAST LEAKAGE AND THE HYDRONEPHROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143515 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R