BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3838197 · Received May 29, 2014

    Report

    Report Number
    9616099-2014-00349
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    POST-DILATATION WAS PERFORMED ROUTINELY IN ALL LESIONS WITH A BALLOON OF 5-MM DIAMETER AT A PRESSURE OF 14 ATMOSPHERES. DUAL ANTI-PLATELET THERAPY WAS STARTED AT LEAST 1 WEEK PRIOR TO EVT AND CONTINUED DURING THE FOLLOW-UP PERIOD. PROCEDURAL SUCCESS WAS DEFINED AS RESIDUAL STENOSIS <30% AND THE ABSENCE OF FLOW-LIMITING DISSECTION ON ANGIOGRAPHY. ANGIOGRAPHY WAS OBTAINED BEFORE EVT, IMMEDIATELY AFTER EVT, AND AT 6- MONTH FOLLOW-UP WITH ANTEROPOSTERIOR AND/OR OBLIQUE VIEW. QUANTITATIVE VASCULAR ANGIOGRAPHY (QVA) ANALYSIS USING COMMERCIALLY AVAILABLE SOFTWARE WAS DONE TO DETERMINE LESION SEVERITY AND TO EVALUATE NEOINTIMAL HYPERPLASIA (NIH) AT FOLLOW-UP IN A BLINDED FASHION. ANGIOGRAPHIC RESTENOSIS WAS DEFINED AS RECURRENCE OF >50% DS AS DETERMINED ON QVA ANALYSIS WITHIN THE STENTED SEGMENT OR WITHIN THE 5-MM SEGMENT PROXIMAL OR DISTAL TO THE STENT EDGE. STENT FRACTURE WAS DEFINED AS CLEAR INTERRUPTION OF STENT STRUTS IDENTIFIED ON X-RAY FROM MULTIPLE PROJECTIONS. IVUS DONE IN ALL CASES WITH A COMMERCIALLY AVAILABLE IVUS CONSOLE. AT THE END OF THE INITIAL PROCEDURE AND AT 6-MONTH FOLLOW-UP, A SLOW PULLBACK WAS PERFORMED FROM DISTAL TO PROXIMAL REFERENCE SITES THROUGH THE STENTED SEGMENT. A MANUAL PULLBACK AT A CONSTANT SPEED OF 10MM/S WAS PERFORMED AFTER INITIAL DEPLOYMENT AND AT FOLLOW-UP. ALL IVUS IMAGES WERE REVIEWED AND QUANTITATIVE IVUS ANALYSIS WAS PERFORMED USING COMPUTER PLANIMETRY BY AN INDEPENDENT EXPERIENCED OBSERVER WHO WAS BLINDED TO THE CLINICAL AND ANGIOGRAPHIC INFORMATION. QUALITATIVE MEASURES ASSESSED IN THE STUDY INCLUDED (1) STENT EDGE DISSECTION (DEFINED AS THE DISRUPTION OF THE VESSEL LUMINAL SURFACE AT THE STENT EDGES WITH VISIBLE FLAP), (2) TISSUE PROTRUSION AFTER STENT DEPLOYMENT (DEFINED AS PROTRUSION OF TISSUE BETWEEN STENT STRUTS EXTENDING INSIDE A CIRCULAR ARC CONNECTING ADJACENT STRUTS ON IVUS IMAGES AND (3) THROMBUS AT FOLLOW-UP (DEFINED AS A LOW ECHOIC MASS, OFTEN MOBILE AND EXTRUDING INTO THE VESSEL LUMEN AND SOMETIMES BECOMING DETACHED FROM THE VESSEL WALL. TO FURTHER INVESTIGATE THE IN VIVO MECHANICAL BEHAVIOR OF THE SELF-EXPANDING STENT AND THE VASCULAR RESPONSE IN THE ENTIRE LESION SEGMENT, SERIAL VOLUMETRIC ANALYSIS WAS PERFORMED IMMEDIATELY AFTER STENT DEPLOYMENT AND AT 6-MONTH FOLLOW-UP WITHIN THE STENT AND IN THE PERSISTENT MARGINS. A TOTAL OF 38 DE-NOVO SFA LESIONS WERE ANALYZED IN THIS STUDY. BMS WERE IMPLANTED IN 25 LESIONS OF 21 PATIENTS AND PES WERE DEPLOYED IN 13 LESIONS OF 11 PATIENTS. INITIAL PROCEDURAL SUCCESS WAS OBTAINED IN ALL CASES AND NO PROCEDURE-RELATED COMPLICATIONS WERE REPORTED BOTH AT BASELINE AND AT FOLLOW-UP. THERE WERE NO STENT FRACTURES DETECTED IN THE BMS GROUP AT 6-MONTH FOLLOW-UP. THERE WERE 5 CASES OF TISSUE PROTRUSION AFTER INITIAL STENTING IN THE BMS GROUP. AMONG 20 DISSECTIONS IDENTIFIED ON IVUS AT THE INITIAL STENT DEPLOYMENT, 8 DISSECTIONS RESOLVED, AND 12 DISSECTIONS PERSISTED DURING THE FOLLOW-UP PERIOD IN BOTH GROUPS (PES AND BMS). NO SIGNIFICANT DIFFERENCES IN THE NATURAL HISTORY OF STENT EDGE DISSECTION EXISTED BETWEEN THE TWO GROUPS. IN THIS STUDY, APPROXIMATELY HALF OF STENT EDGE DISSECTIONS RESOLVED DURING THE 6-MONTH FOLLOW-UP PERIOD BOTH IN THE PES GROUP AND BMS GROUP. MOREOVER, NO EDGE RESTENOSIS AT FOLLOW-UP WAS DETECTED FOR LESIONS IN WHICH EDGE DISSECTION WAS IDENTIFIED AT THE BASELINE PROCEDURE. THE LOT NUMBER OF THE DEVICES USED IN THE STUDY ARE UNKNOWN ACCORDING TO THE AFFILIATE. NO PATIENT SPECIFIC DETAILS COULD BE OBTAINED. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. THIS ARTICLE WAS FOUND DURING A LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: MIKI ET AL (2014, APRIL 9). EFFECT OF BARE-METAL NITINOL STENT IMPLANTATION AND PACLITAXEL-ELUTING NITINOL STENT IMPLANTATION ON VASCULAR RESPONSE IN THE SUPERFICIAL FEMORAL ARTERY LESION ASSESSED ON INTRAVASCULAR ULTRASOUND. CIRCULATION JOURNAL. ONE MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS (14 EVENTS) WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. THIS IS ONE OF TWO PRODUCT ISSUES INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00349 & 9616099-2014-00350. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, OR CLIOSTAZOL. COMPLAINT CONCLUSION: AS REPORTED IN THE PUBLICATION MIKI ET AL EFFECT OF BARE-METAL NITINOL STENT IMPLANTATION AND PACLITAXEL-ELUTING NITINOL STENT IMPLANTATION ON VASCULAR RESPONSE IN THE SUPERFICIAL FEMORAL ARTERY LESION ASSESSED ON INTRAVASCULAR ULTRASOUND, CIRCULATION JOURNAL 2014; THERE WERE 14 CASES OF STENT EDGE DISSECTION AFTER INITIAL STENTING OF A SMART CONTROL STENT. 8 OF THESE DISSECTIONS PERSISTED DURING THE 6 MONTH FOLLOW-UP PERIOD. THERE WERE 6 CASES OF ANGIOGRAPHIC RESTENOSIS AT 6-MONTH FOLLOW-UP IN THE SMART CONTROL GROUP. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE CHRONIC VASCULAR RESPONSE TO THE IMPLANTATION OF PES AND BMS IN SUPERFICIAL FEMORAL ARTERY (SFA) LESIONS USING SERIAL VOLUMETRIC INTRAVASCULAR ULTRASOUND (IVUS). ALL OF THE PATIENTS SUFFERED FROM SYMPTOMS DUE TO SFA LESIONS (RUTHERFORD 2-5) THAT AFFECTED QUALITY OF LIFE DESPITE EXERCISE AND OPTIMAL MEDICATION. DE NOVO SFA LESIONS WERE TREATED WITH THE SMART CONTROL STENT (BMS) OR ZILVER PTX STENT (PES). AFTER THE INITIAL DIAGNOSTIC ANGIOGRAPHY OF THE LOWER LIMB, INDICATIONS FOR ENDOVASCULAR THERAPY (EVT) WERE DECIDED BY MORE THAN 2 PHYSICIANS. APPROACH FOR EVT WAS DETERMINED AT THE OPERATOR¿S DISCRETION. AFTER INSERTION OF A 6F SHEATH, UNFRACTIONATED HEPARIN (5,000 UNITS) WAS GIVEN INTO THE ARTERY. AFTER A 0.014/0.018-INCH GUIDEWIRE WAS ADVANCED DOWN TO THE LESION, PRE-DILATATION WAS PERFORMED BY THE BALLOON WITH A DIAMETER EQUAL TO THE REFERENCE VESSEL DIAMETER ACCORDING TO THE VISUAL ESTIMATION. WHEN FLOW-LIMITING DISSECTIONS OR RECOILS CAUSED A STENOSIS >30%, BMS OR PES WAS IMPLANTED. STENT DIAMETER THAT WAS 102MM LARGER THAN THE REFERENCE VESSEL DIAMETER AT PROXIMAL SITES OF THE LESIONS ON ANGIOGRAPHIC VISUAL ESTIMATION WAS CHOSEN. WHEN MULTIPLE STENTS WERE REQUIRED, THE MARGIN OF THE OVERLAPPING STENT WAS <10MM. POST-DILATATION WAS PERFORMED ROUTINELY IN ALL LESIONS WITH A BALLOON OF 5-MM DIAMETER AT A PRESSURE OF 14 ATMOSPHERES. DUAL ANTI-PLATELET THERAPY WAS STARTED AT LEAST 1 WEEK PRIOR TO EVT AND CONTINUED DURING THE FOLLOW-UP PERIOD. PROCEDURAL SUCCESS WAS DEFINED AS RESIDUAL STENOSIS <30% AND THE ABSENCE OF FLOW-LIMITING DISSECTION ON ANGIOGRAPHY. ANGIOGRAPHY WAS OBTAINED BEFORE EVT, IMMEDIATELY AFTER EVT, AND AT 6- MONTH FOLLOW-UP WITH ANTEROPOSTERIOR AND/OR OBLIQUE VIEW. QUANTITATIVE VASCULAR ANGIOGRAPHY (QVA) ANALYSIS USING COMMERCIALLY AVAILABLE SOFTWARE WAS DONE TO DETERMINE LESION SEVERITY AND TO EVALUATE NEOINTIMAL HYPERPLASIA (NIH) AT FOLLOW-UP IN A BLINDED FASHION. ANGIOGRAPHIC RESTENOSIS WAS DEFINED AS RECURRENCE OF >50% DS AS DETERMINED ON QVA ANALYSIS WITHIN THE STENTED SEGMENT OR WITHIN THE 5-MM SEGMENT PROXIMAL OR DISTAL TO THE STENT EDGE. STENT FRACTURE WAS DEFINED AS CLEAR INTERRUPTION OF STENT STRUTS IDENTIFIED ON X-RAY FROM MULTIPLE PROJECTIONS. IVUS DONE IN ALL CASES WITH A COMMERCIALLY AVAILABLE IVUS CONSOLE. AT THE END OF THE INITIAL PROCEDURE AND AT 6-MONTH FOLLOW-UP, A SLOW PULLBACK WAS PERFORMED FROM DISTAL TO PROXIMAL REFERENCE SITES THROUGH THE STENTED SEGMENT. A MANUAL PULLBACK AT A CONSTANT SPEED OF 10MM/S WAS PERFORMED AFTER INITIAL DEPLOYMENT AND AT FOLLOW-UP. ALL IVUS IMAGES WERE REVIEWED AND QUANTITATIVE IVUS ANALYSIS WAS PERFORMED USING COMPUTER PLANIMETRY BY AN INDEPENDENT EXPERIENCED OBSERVER WHO WAS BLINDED TO THE CLINICAL AND ANGIOGRAPHIC INFORMATION. QUALITATIVE MEASURES ASSESSED IN THE STUDY INCLUDED (1) STENT EDGE DISSECTION (DEFINED AS THE DISRUPTION OF THE VESSEL LUMINAL SURFACE AT THE STENT EDGES WITH VISIBLE FLAP), (2) TISSUE PROTRUSION AFTER STENT DEPLOYMENT (DEFINED AS PROTRUSION OF TISSUE BETWEEN STENT STRUTS EXTENDING INSIDE A CIRCULAR ARC CONNECTING ADJACENT STRUTS ON IVUS IMAGES AND (3) THROMBUS AT FOLLOW-UP (DEFINED AS A LOW ECHOIC MASS, OFTEN MOBILE AND EXTRUDING INTO THE VESSEL LUMEN AND SOMETIMES BECOMING DETACHED FROM THE VESSEL WALL. TO FURTHER INVESTIGATE THE IN VIVO MECHANICAL BEHAVIOR OF THE SELF-EXPANDING STENT AND THE VASCULAR RESPONSE IN THE ENTIRE LESION SEGMENT, SERIAL VOLUMETRIC ANALYSIS WAS PERFORMED IMMEDIATELY AFTER STENT DEPLOYMENT AND AT 6-MONTH FOLLOW-UP WITHIN THE STENT AND IN THE PERSISTENT MARGINS. A TOTAL OF 38 DE-NOVO SFA LESIONS WERE ANALYZED IN THIS STUDY. BMS WERE IMPLANTED IN 25 LESIONS OF 21 PATIENTS AND PES WERE DEPLOYED IN 13 LESIONS OF 11 PATIENTS. INITIAL PROCEDURAL SUCCESS WAS OBTAINED IN ALL CASES AND NO PROCEDURE-RELATED COMPLICATIONS WERE REPORTED BOTH AT BASELINE AND AT FOLLOW-UP. THERE WERE NO STENT FRACTURES DETECTED IN THE BMS GROUP AT 6-MONTH FOLLOW-UP. THERE WERE 5 CASES OF TISSUE PROTRUSION AFTER INITIAL STENTING IN THE BMS GROUP. AMONG 20 DISSECTIONS IDENTIFIED ON IVUS AT THE INITIAL STENT DEPLOYMENT, 8 DISSECTIONS RESOLVED, AND 12 DISSECTIONS PERSISTED DURING THE FOLLOW-UP PERIOD IN BOTH GROUPS (PES AND BMS). NO SIGNIFICANT DIFFERENCES IN THE NATURAL HISTORY OF STENT EDGE DISSECTION EXISTED BETWEEN THE TWO GROUPS. IN THIS STUDY, APPROXIMATELY HALF OF STENT EDGE DISSECTIONS RESOLVED DURING THE 6-MONTH FOLLOW-UP PERIOD BOTH IN THE PES GROUP AND BMS GROUP. MOREOVER, NO EDGE RESTENOSIS AT FOLLOW-UP WAS DETECTED FOR LESIONS IN WHICH EDGE DISSECTION WAS IDENTIFIED AT THE BASELINE PROCEDURE. THE LOT NUMBER OF THE DEVICES USED IN THE STUDY ARE UNKNOWN ACCORDING TO THE AFFILIATE. NO PATIENT SPECIFIC DETAILS COULD BE OBTAINED. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. THE COMPLAINT PRODUCTS WERE NOT RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENTS. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED IN THE PUBLICATION MIKI ET AL EFFECT OF BARE-METAL NITINOL STENT IMPLANTATION AND PACLITAXEL-ELUTING NITINOL STENT IMPLANTATION ON VASCULAR RESPONSE IN THE SUPERFICIAL FEMORAL ARTERY LESION ASSESSED ON INTRAVASCULAR ULTRASOUND, CIRCULATION JOURNAL 2014; THERE WERE 14 CASES OF STENT EDGE DISSECTION AFTER INITIAL STENTING OF A SMART CONTROL STENT. EIGHT (8) OF THESE DISSECTIONS PERSISTED DURING THE 6 MONTH FOLLOW-UP PERIOD. THERE WERE 6 CASES OF ANGIOGRAPHIC RESTENOSIS AT 6-MONTH FOLLOW-UP IN THE SMART CONTROL GROUP. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE CHRONIC VASCULAR RESPONSE TO THE IMPLANTATION OF PES AND BMS IN SUPERFICIAL FEMORAL ARTERY (SFA) LESIONS USING SERIAL VOLUMETRIC INTRAVASCULAR ULTRASOUND (IVUS). ALL OF THE PATIENTS SUFFERED FROM SYMPTOMS DUE TO SFA LESIONS (RUTHERFORD 2-5) THAT AFFECTED QUALITY OF LIFE DESPITE EXERCISE AND OPTIMAL MEDICATION. DE NOVO SFA LESIONS WERE TREATED WITH THE SMART CONTROL STENT (BMS) OR ZILVER PTX STENT (PES). AFTER THE INITIAL DIAGNOSTIC ANGIOGRAPHY OF THE LOWER LIMB, INDICATIONS FOR ENDOVASCULAR THERAPY (EVT) WERE DECIDED BY MORE THAN 2 PHYSICIANS. APPROACH FOR EVT WAS DETERMINED WAS DETERMINED AT THE OPERATOR'S DISCRETION. AFTER INSERTION OF A 6F SHEATH, UNFRACTIONATED HEPARIN (5,000 UNITS) WAS GIVEN INTO THE ARTERY. AFTER A 0.014/0.018-INCH GUIDEWIRE WAS ADVANCED DOWN TO THE LESION, PRE-DILATATION WAS PERFORMED BY THE BALLOON WITH A DIAMETER EQUAL TO THE REFERENCE VESSEL DIAMETER ACCORDING TO THE VISUAL ESTIMATION. WHEN FLOW-LIMITING DISSECTIONS OR RECOILS CAUSED A STENOSIS >30%, BMS OR PES WAS IMPLANTED. STENT DIAMETER THAT WAS 102MM LARGER THAN THE REFERENCE VESSEL DIAMETER AT PROXIMAL SITES OF THE LESIONS ON ANGIOGRAPHIC VISUAL ESTIMATION WAS CHOSEN. WHEN MULTIPLE STENTS WERE REQUIRED, THE MARGIN OF THE OVERLAPPING STENT WAS <10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316990 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S