BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNALINK SELF-EXPANDING STENT SYSTEM

    MDR report key: 3150571 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03530
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ABSOLUTE STENT DELIVERY SYSTEM REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RESTENOSIS IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF 'IN-STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY'. AS THE NUMBER OF ENDOVASCULAR PERIPHERAL ARTERIAL INTERVENTIONS IS INCREASING NATIONWIDE, SO IS THE RATE OF OBSERVED IN-STENT RESTENOSIS, SPECIFICALLY IN THE SUPERFICIAL FEMORAL ARTERY. A PAUCITY OF LITERATURE IS AVAILABLE REGARDING THE PATHOPHYSIOLOGY, RISK FACTORS, AND THERAPIES ASSOCIATED WITH IN-STENT RESTENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. THIS ARTICLE SUMMARIZES THE ACCUMULATED KNOWLEDGE ON THESE TOPICS AND SHEDS SOME LIGHT ON THE PROSPECTS FOR FUTURE THERAPIES. TWO STUDIES REFERENCED IN THE ARTICLE INVOLVED ABBOTT STENTS, THE OTHER STUDIES REFERENCED DID NOT INVOLVE ABBOTT STENTS. THE FIRST STUDY TITLED BALLOON ANGIOPLASTY VERSUS IMPLANTATION OF NITINOL STENTS IN THE SUPERFICIAL FEMORAL ARTERY, INVOLVED DYNALINK AND ABSOLUTE STENTS. THE FIRST STUDY INVOLVED 104 PATIENTS AND EVALUATED THE INSTENT RESTENOSIS RATES VERSUS PERCUTANEOUS TRANSLUMINAL ANGIOGPLASTY (PTA) AND THE RESULTS ARE AS FOLLOWS: AT 6 MONTHS, 43% IN PTA VS. 24% IN-STENT RESTENOSIS. AT 12 MONTHS, 63% IN PTA VS. 37% IN-STENT RESTENOSIS. THE SUMMARY OF THE ARTICLE REFERENCING THESE DEVICES DOES NOT INCLUDE INFORMATION ON WHETHER OR NOT TREATMENT WAS PERFORMED FOR THE RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250116 DYNALINK SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O