BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT

    MDR report key: 6360074 · Received February 27, 2017

    Report

    Report Number
    3002808486-2017-00664
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    July 27, 2012
    Report Date
    August 2, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MAF
    UDI-DI
    10827002455037
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).SIMILAR TO DEVICE UNDER 510(K) P100028. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE TREATMENT AREA WAS THE RVOT (RIGHT VENTRICULAR OUTFLOW TRACT) AND IS AN OFF LABEL INDICATION. A FORX4-14-80-7-20 SYSTEM WAS ADVANCED AND EXPANDED INSIDE AN EXISTING STENT WITHOUT ANY COMPLICATIONS. AN ANGIOGRAM SHOWS THAT THE STENT HAS RESTORED FLOW, BUT AROUND THE DISTAL THIRD PART OF THE STENT THE PASSAGE NARROWS SLIGHTLY. WHEN PERFORMING A POST-DILATION OF THE STENT WITH THE FORX4- BALLOON CATHETER, THE PHYSICIAN DISCOVERS THAT THE BALLOON HAS BURSTED. VISUAL INSPECTION OF THE PROXIMAL PART OF THE BALLOON SECTION SHOW THAT IT IS BURSTED LONGITUDINALLY. THE ANGIOGRAM SHOWS THAT THE PROXIMAL PART OF THE STENT DOES NOT ALIGN 100% WITH THE VESSEL WALL DUE TO A 100-110° ANGLE VASCULAR. FROM OUR INVESTIGATION WE ARE NOT ABLE TO FIND ANY OBVIOUS CORRELATION BETWEEN THE INCIDENT AND A PRODUCT ERROR. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DR. ADVISED IMPLANTING A COOK FORMULA 414 STENT FOR ROVR OBSTRUCTION WHERE HE HAD INFLATED THE BALLOON AND IT BURST AND FRACTURED AND OBSTRUCTED PULMONARY BLOOD FLOW. HE RETRIEVED THE FRAGMENT. ATTEMPTED SNARE RETRIEVAL OVER WIRE- DIFFICULT. BALLOON FRAGMENT OBSTRUCTED PULMONARY BLOOD FLOW WITH STATS OF 28% - MANAGED TO EMBOLIZE THIS TO LPA AND ESTABLISH PULMONARY BLOOD FLOW. FURTHER EVENTUAL RETRIEVAL FROM LPA AND THEN FROM DESCENDING AORTA. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES - RETRIEVAL OF DISLODGED BALLOON SEGMENT. NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURENCE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143133 FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT WLQ BALLOON STENT MAF WILLIAM COOK EUROPE 10827002455037

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Life Threatening| R