BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1981221 · Received February 8, 2011

    Report

    Report Number
    9616099-2011-00085
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    August 24, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED DURING THE INDEX PROCEDURE: A 6MM FRENCH VASCULAR SHEATH, A GUIDEWIRE AND A BALLOON CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY FIVE AND ONE HALF MONTHS POST STENT IMPLANTATION, THE (B)(4) STUDY PATIENT HAD STENT FRACTURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY SIGNIFICANT FOR RIGHT-LEG PERIPHERAL VASCULAR DISEASE WITH BELOW-THE-KNEE INVOLVEMENT ((B)(6) 2007), PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENT DEPLOYMENT TO THE LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES ((B)(6) 2007), HYPERCHOLESTEROLEMIA, HYPERTENSION, AND ALLERGY TO SULFA. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH A 70% STENOTIC LESION IN THE MIDDLE SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS 6MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A SMART CONTROL NITINOL STENT WAS IMPLANTED. THE STENT WAS POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED HOME ON ASPIRIN AND CLOPIDOGREL. DURING A FOLLOW-UP VISIT, APPROXIMATELY FIVE AND A HALF MONTHS POST INDEX PROCEDURE, THE PATIENT HAD AN X-RAY TAKEN AND A TYPE I STENT FRACTURE WAS NOTED. THE DETAILS OF THE FRACTURE ARE AS FOLLOWS: 10 DEGREE ANGLE OF FRACTURE, 0 MISALIGNED, 1 ALIGNED, 1.5 MM STENT GAP, 59.99 MM STENT LENGTH, -2 MM DISTANCE OF THE FRACTURE TO RESTENOSIS AND -2 MM DISTANCE OF THE FRACTURE RELATIVE TO THE LESSER TROCHANTER OF THE FEMUR. TO DATE, DESPITE MULTIPLE ATTEMPTS, NO FURTHER INFORMATION HAS BEEN AVAILABLE REGARDING THE REPORTED STENT FRACTURE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 13431304 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 13431304. CRIMPED STENT 7 X 150MM LOTS 13429748 AND 13426916 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW OF THESE LOTS THAT NO NONCONFORMANCES WERE GENERATED, AND NO INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE RECEIVING INSPECTION RECORDS FOR THE EXPANDED STENT 7 X 150MM LOTS 200806180115, 200806110181 AND 200806180133 WERE REVIEWED, AND THESE LOTS WERE DEEMED ACCEPTABLE. MANUFACTURING RECORDS FOR STENT LOTS 13426916 AND 13429748 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO (B)(4) AND THE RESULTS INDICATE THAT THE STENT RECEIVED AT (B)(4) MEETS SPECIFIED RELEASE REQUIREMENTS. THE OPERATOR QUALIFICATION RECORDS FOR STENT LOAD INTO OM, ACCORDING TO MWI (B)(4) WERE REVIEWED. THE OPERATOR THAT PERFORMED THIS OPERATION WAS QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTION REVISION AT THE TIME OF THE LOT MANUFACTURING. CALIBRATION RECORDS FOR STENT LOADING MACHINE, WITH CALIBRATION ID: (B)(4), WERE REVIEWED AND IT WAS FOUND THAT THE EQUIPMENT / TOOL WERE CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORDS FOR STENT LOADING MACHINE WITH EQUIPMENT ID: (B)(4) WERE REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE SFA. THE SFA IS A VERY DYNAMIC VESSEL THAT UNDERGOES BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT NITINOL STENT FRACTURES OCCURRED IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP VISIT, APPROXIMATELY FIVE AND A HALF MONTHS POST INDEX PROCEDURE THE PATIENT HAD AN X-RAY TAKEN AND A TYPE I STENT FRACTURE WAS NOTED. THE DETAILS OF THE FRACTURE ARE AS FOLLOWS: 10O ANGLE OF FRACTURE, 0 MISALIGNED, 1 ALIGNED, 1.5 MM STENT GAP, 59.99 MM STENT LENGTH, -2 MM DISTANCE OF THE FRACTURE TO RESTENOSIS AND -2 MM DISTANCE OF THE FRACTURE RELATIVE TO THE LESSER TROCHANTER OF THE FEMUR. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH A 70% STENOTIC LESION IN THE MIDDLE SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS 6MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A SMART CONTROL NITINOL STENT WAS IMPLANTED. THE STENT WAS POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED HOME ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 13431304

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization