BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT

    MDR report key: 2425814 · Received January 19, 2012

    Report

    Report Number
    3002808486-2011-00050
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    NIN
    PMA / PMN Number
    P100028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 7X12 MM FORMULA BALLOON CATHETER WAS RETURNED IN THE ORIGINAL PACKAGING TOGETHER WITH A SNARE OF UNKNOWN ORIGIN. A STENT WAS CAPTURED BY THE SNARE. VISUAL INSPECTION OF THE BALLOON SHOWED NO DEFECTS, AND THE BALLOON APPEARED TO HAVE BEEN FULLY INFLATED. VISUAL INSPECTION OF THE STENT SHOWED TWO INTACT COMPRESSED STENT SECTIONS CONSISTING OF TWO SEGMENTS EACH AND ONE STENT SECTION OF TWO SEGMENTS THAT WAS COMPLETELY DEFORMED WITH THE SNARE LOCATED BETWEEN THE INTACT AND DEFORMED PART OF THE STENT. THIS IS CONSISTENT WITH THE RETURNED IMAGES, THAT SHOW ONE EXPANDED STENT SECTION AND TWO UNEXPANDED SECTIONS. THE DEFORMATION OF THE STENT IS ASSESSED TO BE CAUSED BY THE RETRIEVAL OF THE STENT USING THE SNARE. THE INTACT COMPRESSED PART OF THE STENT WAS MEASURED TO 1.68 MM, WHICH IS CONSISTENT WITH A 7X12 MM FORMULA STENT. SOME LIGHT COLORED FIBERS WERE OBSERVED TO BE ATTACHED TO THE CLOTTED BLOOD AROUND THE STENT/SNARE, IT IS HOWEVER NOT POSSIBLE TO DETERMINE THE ORIGIN OF THESE FIBERS. THE EVENT DESCRIPTION STATES "THERE WAS SEVERE BLOCKAGE IN BOTH COMMON ILIACS WHICH REQUIRED KISSING STENTS. THE PHYSICIAN PLACED 2 FORMULA STENTS, OFF LABEL, 7X20 R AND 6X20 L. THE RIGHT WAS A BIT LOWER THAN LEFT UPON DEPLOYMENT SO THE PHYSICIAN DECIDED TO EXTEND THE RIGHT WITH A 7X12. WHEN INFLATING THE BALLOON THE STENT STRIPPED OFF AND HAD TO BE SNARED FROM THE LEFT SIDE AFTER A 4 HOUR STRUGGLE." THIS IS NOT IN ACCORDANCE WITH IFU I-FORX414-1102-395-01EN WHICH STATES IN THE SECTION INTENDED USE: "THE FORMULA 414RX RENAL BALLOON-EXPANDABLE STENT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH ARTHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES." MOREOVER THE IFU STATES IN THE SECTION POSITIONING OF THE STENT: "NOTE: WHEN STENTING LONG LESIONS, BE SURE TO COVER THE DISTAL PORTION OF THE LESION FIRST." ACCORDING TO THE RETURNED IMAGES THE STENT WAS RELEASED DISTALLY TO AN ALREADY IMPLANTED STENT. IN CONCLUSION THE EXACT CAUSE WHY THE STENT WAS ONLY PARTLY EXPANDED AND EXPELLED FROM THE CATHETER CANNOT BE DETERMINED. HOWEVER, OFF LABEL USE MAY HAVE BEEN A CONTRIBUTING FACTOR. CONTINUOUS MONITORING FOR SIMILAR EVENTS IS IN PLACE.

    Description of Event or Problem · 1

    THERE WAS SEVERE BLOCKAGE IN BOTH COMMON ILIACS WHICH REQUIRED KISSING STENTS. THE PHYSICIAN PLACED 2 FORMULA STENTS, OFF LABEL, 7X20 R AND 6X20 L. TH RIGHT WAS A BIT LOWER THAN LEFT UPON DEPLOYMENT SO THE PHYSICIAN DECIDED TO EXTEND THE RIGHT WITH A 7X12. WHEN INFLATING THE BALLOON THE STENT STRIPPED OFF AND HAD TO BE SNARED FROM THE LEFT SIDE AFTER A 4 HOUR STRUGGLE. (B)(6) 2012: ACCORDING TO THE AREA REP WHO WAS CONTACTED BY THE DR. WHO STATED: "THE PATIENT IS DOING FINE. THE PATIENT WILL BE SEEN IN THE CLINIC IN TWO WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT WLQ BALLOON STENT NIN WILLIAM COOK EUROPE NA E2744681

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention