BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA 414 RX BALLOON-EXPANDABLE STENT

    MDR report key: 6344978 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00566
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 12, 2014
    Report Date
    June 23, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002037004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P100028. SUMMARY OF INVESTIGATIONAL FINDINGS: AS PER ATTACHED COMPLAINT FORM IT IS ASSUMED THE FORMULA STENT WAS IMPLANTED (B)(6) 2014. FOLLOW-UP AFTER 2 WEEKS WAS GOOD, BUT AFTER 5-6 WEEKS PATIENT GOT ECZEMA. THE FORMULA BALLOON EXPANDABLE STENT IS A NONDRUG ELUTED DEVICE, WHY IT IS DIFFICULT TO COMMENT ON PATIENTS ALLERGIC REACTIONS. HOWEVER, REFERENCE SHOULD BE MADE TO (B)(4). WARNINGS: "PERSONS ALLERGIC TO 316L STAINLESS STEEL MAY SUFFER AN ALLERGIC REACTION TO THIS IMPLANT." POTENTIAL ADVERSE EVENTS: "ALLERGIC REACTION TO STAINLESS STEEL OR CONTRAST AGENTS" AND "ARTERY THROMBOSIS, ANEURYSM, RUPTURE, PERFORATION , OCCLUSION, SPASM, OR RESTENOSIS." NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT HAS AN ALLERGY AND THEY WANT TO KNOW WHAT MEDICATION IS ON THE STENT AS THEY WANT TO CHECK THAT TOO. THE DOCTOR MAKE A NORMAL RENAL INTERVENTION TO TREAT A STENOSIS IN THE RIGHT RENAL ARTERY. AT FIRST STEP HE DILATATED WITH BALLOON CATHETER (2 TIMES WITH DIFFERENT SIZES) AND AFTER THAT HE IMPLANTED THE FORMULA STENT. AFTER 2 WEEKS THE FOLLOW UP FROM THE TREATMENT WAS GOOD. ON (B)(6) 2014: THE PATIENT GET AN EXANTHEMA AND THEREFORE, HE DECIDE TO STOP TAKING THE CLOPIDOGREL. ON (B)(6) 2014: THE EXTHEMA GROW UP AND THEREFORE, THEY STOP THE ASPIRIN ALSO. ON (B)(6) 2014: THE DOCTOR MAKE AN X-RAY FROM THE RENAL ARTERY AND FOUND AN IN STENT RESTENOSIS. THE NEXT STEP IS TO PRESENT THE PATIENT TO THE UNIVERSITY OF BONN TO MAKE A DIAGNOSTIC ABOUT ALLERGY. PATIENT OUTCOME: THE PATIENT COME BACK IN DEPENDS OF HER ALLERGY, IN THIS TIME SHE BECAME A REINTERVENTION TO PROOF THE STENT, AND SHE MUST GO TO THE UNIVERSITY OF BONN TO CONTROL HER ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130033 FORMULA 414 RX BALLOON-EXPANDABLE STENT WLQ BALLOON STENT DTK WILLIAM COOK EUROPE 10827002037004

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR