BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6688893 · Received July 6, 2017

    Report

    Report Number
    9612164-2017-00858
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    January 3, 2017
    Report Date
    June 7, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE TITLE: ACUTE HYPERSENSITIVITY REACTION TO FEMORAL DRUG-COATED BALLOONS EDWARD LAKE, MICHAEL TWIGG, AND FINN FARQUHARSON CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST, MANCHESTER, UNITED KINGDOM VASA (2017), 46 (3), 223¿225 HTTPS://DOI.ORG/10.1024/0301-1526/A000604 © 2017 HOGREFE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH CRITICAL ISCHAEMIA OF THE RIGHT FOOT WITH REST PAIN AND INFECTED NON-HEALING ULCERATION. AN ARTERIAL DUPLEX REVEALED TRIPHASIC FEMORAL WAVEFORMS AND MONOPHASIC POPLITEAL WAVEFORMS IN THE RIGHT LEG, INDICATIVE OF A DISTAL SFA TO PROXIMAL POPLITEAL ARTERY STENOSIS. ON EXAMINATION, THE PATIENT HAD SEVERE CIRCUMFERENTIAL INFECTED ULCERATION TO THE RIGHT LOWER LEG AND DORSUM OF THE FOOT. THERE WERE NO RASHES OR CELLULITIS ABOVE THE KNEE. THE PATIENT UNDERWENT A DISTAL SFA AND PROXIMAL POPLITEAL ARTERY ANGIOPLASTY. A 6F SHEATH WAS INSERTED FOLLOWING ANTEGRADE COMMON FEMORAL PUNCTURE. ANGIOGRAM CONFIRMED A STENOTIC SEGMENT IN THE DISTAL SFA, CORRELATING WITH THE REGION OF PREVIOUS ANGIOPLASTY. THERE WAS SINGLE VESSEL RUN-OFF INTO THE FOOT VIA THE ANTERIOR TIBIAL ARTERY, WITH AN INCOMPLETE PLANTAR ARCH AND OCCLUDED POSTERIOR TIBIAL ARTERY. ANGIOPLASTY OF THE FA/POPLITEAL STENOSIS WAS PERFORMED USING A 5 X120 MM IN.PACT ADMIRAL DRUG COATED BALLOON. BALLOON INFLATION TIME WAS ONE MINUTE. A COMPLETION ANGIOGRAM SHOWED A SATISFACTORY ANGIOGRAPHIC RESULT OF THE TREATED SEGMENT. WITHIN A MINUTE OF REMOVING THE BALLOON, THE PATIENT COMPLAINED OF SEVERE PAIN IN THEIR RIGHT THIGH, AND BECAME EXTREMELY AGITATED. PATIENT BECAME TACHYCARDIC AT A RATE OF 175 BPM, AND HYPERTENSIVE AT 180/106 MMHG. AN ERYTHEMATOUS RASH QUICKLY DEVELOPED IN THE RIGHT LOWER THIGH DIRECTLY OVER THE REGION THAT HAD BEEN ANGIOPLASTIED. THE FOOT REMAINED WARM AND WELL PERFUSED. 10 MG OF MORPHINE ANALGESIA WAS ADMINISTERED, ALONG WITH OXYGEN VIA A FACEMASK, AND 100 MG INTRAVENOUS HYDROCORTISONE AS WELL AS 10 MG INTRAVENOUS CHLORPHENAMINE. THERE WAS NO GENERALISED RASH, ANGIOEDEMA OR BREATHING DIFFICULTY. THE AREA OF ERYTHEMA TO THE THIGH WAS MARKED. THE PATIENT REMAINED IN SIGNIFICANT PAIN IN THE THIGH, AND ALSO DEVELOPED SOME PAIN IN THE FOOT, REQUIRING FURTHER DOSES OF MORPHINE. THE RASH TO THE THIGH REDUCED OVER THE SUBSEQUENT 48 HOURS. UNFORTUNATELY THE INFECTION IN THE LEG CONTINUED TO DETERIORATE AND THE PATIENT REQUIRED RIGHT ABOVE KNEE AMPUTATION, WHICH HEALED WELL AND GAVE SIGNIFICANT PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470983 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention