BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3753464 · Received April 16, 2014

    Report

    Report Number
    9616099-2014-00268
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 31, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 6-FR CROSSOVER SHEATH (TERUMO, (B)(4)); MULTIPURPOSE CATHETER WITH A 0.035-IN., 1.5-MM, ANGLE-TIPPED, HYDROPHILIC GUIDEWIRE (180 CM LONG; TERUMO, (B)(4)); 5 9 100-MM BALLOON (MUSTANG; BOSTON SCIENTIFIC, (B)(4)); 3 6 9 120- MM DESS (ZILVER PTX; COOK MEDICAL, (B)(4)). PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 3 SMART CONTROL STENTS OF UNKNOWN CATALOG AND LOT NUMBERS THAT WERE IMPLANTED IN THE PATIENT FROM THE ATTACHED PUBLICATION. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: FUKUDA ET AL THE BREAKAGE OF A DRUG-ELUTING STENT DELIVERY SYSTEM LEADING TO LIMB AMPUTATION, CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 29 (2014) 60-64. AS NOTED IN THE PUBLICATION BY FUKUDA ET AL THE BREAKAGE OF A DRUG-ELUTING STENT DELIVERY SYSTEM LEADING TO LIMB AMPUTATION, CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 29 (2014) 60-64; A (B)(6) FEMALE WITH TOTAL OCCLUSION OF THREE SMART BARE METAL STENTS IMPLANTED IN 2010 IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED BY PLACEMENT OF THREE DRUG-ELUTING STENTS. ON PHYSICAL EXAMINATION, HER PULSE WAS WEAK OR ABSENT IN THE POPLITEAL ARTERY, DORSALIS PEDIS, AND POSTERIOR TIBIAL ARTERY OF THE LEFT LEG. PULSE IN THESE VESSELS WAS NORMAL IN THE RIGHT LEG. THE ANKLE/BRACHIAL INDEX WAS 0.38 ON THE LEFT AND 0.85 ON THE RIGHT LEG. COLOR DOPPLER ULTRASONOGRAPHY REVEALED TOTAL OCCLUSION OF THE STENTED SEGMENT OF LEFT SFA. BECAUSE OF RESTING PAIN, SEVERE CARDIOVASCULAR COMORBIDITIES, AND PATIENT¿S PREFERENCE, ENDOVASCULAR THERAPY USING DES WAS SCHEDULED TO TREAT TOTAL OCCLUSION IN THE SFA LESION. THE OCCLUDED SEGMENT WAS APPROACHED USING A CROSSOVER TECHNIQUE FROM THE CONTRALATERAL SIDE WITH A 6-FR CROSSOVER SHEATH (TERUMO, (B)(4)). ANGIOGRAM SHOWED THREE TOTALLY OCCLUDED BARE METAL STENTS FROM PROXIMAL TO DISTAL SFA. BELOW THE KNEE, VESSELS WERE NOT EASILY IDENTIFIABLE BECAUSE OF SLUGGISH BLOOD FLOW. A 5-FR MULTIPURPOSE CATHETER WITH A 0.035-IN., 1.5-MM, ANGLE-TIPPED, HYDROPHILIC GUIDEWIRE (180 CM LONG; TERUMO, (B)(4)) WAS USED TO RECANALIZE THE SFA AND CROSSED THE STENT OCCLUSION. AFTER THE GUIDE WIRE HAD BEEN CROSSED, THE LESION WAS DILATED WITH A 5 9 100-MM BALLOON (MUSTANG; BOSTON SCIENTIFIC, (B)(4)) AT 8 ATM, BUT SIGNIFICANT RESIDUAL STENOSIS PROMPTED PLACEMENT OF THREE 6 9 120- MM DESS (ZILVER PTX; COOK MEDICAL, (B)(4)). POST-DILATATION WAS PERFORMED USING THE SAME 5.0 9 100-MM BALLOON AT 10 ATM. THE FINAL ANGIOGRAM REVEALED SUCCESSFUL RECANALIZATION OF THE SFA. DIGITAL SUBTRACTION ANGIOGRAPHY AFTER STENTING SHOWED THREE PROXIMAL TIBIAL ARTERIES. HOWEVER, BELOW THE ANKLE, THESE ARTERIES WERE NOT EASILY VISUALIZED AND THE ANTERIOR TIBIAL ARTERY (ATA) WAS NOT CONNECTED TO DORSALIS PEDIS ARTERY. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT¿S RESTING PAIN WAS RESOLVED. HOWEVER, 10 H AFTER THE PROCEDURE, LEFT CALF AND FOOT PAIN DEVELOPED. THE PAIN WORSENED, AND CREATININE PHOSPHOKINASE (CPK) WAS ELEVATED. ACUTE OCCLUSION OF DES DUE TO THROMBOSIS WAS SUSPECTED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT THE LOT NUMBERS. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF ENDOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. WELL DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL; PHARMACEUTICAL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE. EVENTS REMAIN ASSOCIATED WITH 3 SMART CONTROL STENTS WITH UNKNOWN CATALOG AND LOT NUMBERS AND THEREFORE THE QUANTITY INVOLVED IN THE REPORT IS 3 DEVICES.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY FUKUDA ET AL THE BREAKAGE OF A DRUG-ELUTING STENT DELIVERY SYSTEM LEADING TO LIMB AMPUTATION, CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 29 (2014) 60-64; A (B)(6) FEMALE WITH TOTAL OCCLUSION OF THREE SMART BARE METAL STENTS IMPLANTED IN 2010 IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED BY PLACEMENT OF THREE DRUG-ELUTING STENTS. ON PHYSICAL EXAMINATION, HER PULSE WAS WEAK OR ABSENT IN THE POPLITEAL ARTERY, DORSALIS PEDIS, AND POSTERIOR TIBIAL ARTERY OF THE LEFT LEG. PULSE IN THESE VESSELS WAS NORMAL IN THE RIGHT LEG. THE ANKLE/BRACHIAL INDEX WAS 0.38 ON THE LEFT AND 0.85 ON THE RIGHT LEG. COLOR DOPPLER ULTRASONOGRAPHY REVEALED TOTAL OCCLUSION OF THE STENTED SEGMENT OF LEFT SFA. BECAUSE OF RESTING PAIN, SEVERE CARDIOVASCULAR COMORBIDITIES, AND PATIENT¿S PREFERENCE, ENDOVASCULAR THERAPY USING DES WAS SCHEDULED TO TREAT TOTAL OCCLUSION IN THE SFA LESION. THE OCCLUDED SEGMENT WAS APPROACHED USING A CROSSOVER TECHNIQUE FROM THE CONTRALATERAL SIDE WITH A 6-FR CROSSOVER SHEATH (TERUMO, (B)(4)). ANGIOGRAM SHOWED THREE TOTALLY OCCLUDED BARE METAL STENTS FROM PROXIMAL TO DISTAL SFA. BELOW THE KNEE, VESSELS WERE NOT EASILY IDENTIFIABLE BECAUSE OF SLUGGISH BLOOD FLOW. A 5-FR CPOST-DILATATION WAS PERFORMED USING THE SAME 5.0 9 100-MM BALLOON AT 10 ATM. THE FINAL ANGIOGRAM REVEALED SUCCESSFUL RECANALIZATION OF THE SFA. DIGITAL SUBTRACTION ANGIOGRAPHY AFTER STENTING SHOWED THREE PROXIMAL TIBIAL ARTERIES. HOWEVER, BELOW THE ANKLE, THESE ARTERIES WERE NOT EASILY VISUALIZED AND THE ANTERIOR TIBIAL ARTERY (ATA) WAS NOT CONNECTED TO DORSALIS PEDIS ARTERY. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT¿S RESTING PAIN WAS RESOLVED. HOWEVER, 10 H AFTER THE PROCEDURE, LEFT CALF AND FOOT PAIN DEVELOPED. THE PAIN WORSENED, AND CREATININE PHOSPHOKINASE (CPK) WAS ELEVATED. ACUTE OCCLUSION OF DES DUE TO THROMBOSIS WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233034 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 68 YR Hospitalization| L| R