BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5986203 · Received September 29, 2016

    Report

    Report Number
    9612164-2016-01009
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 12, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: DATE ARTICLE WAS PUBLISHED. ARTICLE TITLE: DOWNSTREAM PANNICULITIS SECONDARY TO DRUG-ELUTING BALLOON ANGIOPLASTY A C C : CARDI O V A SC U LAR INT E RVENT IONS VOL . 9 , N O . 1 7 , 2 0 1 6 ª 2 0 1 6 B Y T HE AM E R I C AN C O LL EGE OF CAR D IOLOGY FOUNDAT ION I S SN 1 9 3 6 - 8 7 9 8 / $ 3 6 .0 0 P UB L I SHED B Y E L S E V I E R H T T P : / / D X . D O I . O R G / 1 0 . 1 01 6 / J . J C I N . 2 0 1 6 . 0 6 . 0 1 7. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EXAMINATION REVEALED ABSENT POPLITEAL AND PEDAL PULSES IN THE SYMPTOMATIC LEG AND AN ANKLE-BRACHIAL PRESSURE INDEX OF 0.44. MAGNETIC RESONANCE ANGIOGRAPHY REVEALED THROMBOTIC OCCLUSION OF THE BYPASS GRAFT AND MULTIPLE SUBSEQUENT STENOSES. THE PATIENT UNDERWENT ENDOVASCULAR MECHANICAL THROMBECTOMY OF THE BYPASS GRAFT PLUS ANGIOPLASTY OF THE DISTAL BYPASS ANASTOMOSIS AND POPLITEAL ARTERY USING 2 PACLITAXEL-ELUTING BALLOONS (IN.PACT ADMIRAL, (B)(4)) TWO WEEKS LATER, THE PATIENT DEVELOPED A PAINFUL RASH COMPLETELY RESTRICTED TO HER LEFT LOWER LIMB. SHE CONSULTED NUMEROUS PHYSICIANS, BUT NO DIAGNOSIS COULD BE MADE. THREE MONTHS LATER, SHE VISITED OUR OUTPATIENT CLINIC FOR A REGULAR FOLLOW-UP, STILL PRESENTING WITH THE LOCALIZED RASH, WHEREUPON SKIN BIOPSY YIELDED A DIAGNOSIS OF PANNICULITIS. WITH ORAL STEROID TREATMENT, THE RASH GRADUALLY RESOLVED AFTER 3 MONTHS. IN VIEW OF THE HISTOLOGIC FINDINGS, THE REGIONAL DISTRIBUTION OF THE RASH AND THE TEMPORAL RELATIONSHIP TO THE PROCEDURE, THIS REACTION IS COMPATIBLE WITH PANNICULITIS SECONDARY TO PARTICLE EMBOLIZATION OF THE DRUG-ELUTING BALLOON COATING, INCLUDING PACLITAXEL AND UREA COMPONENTS. THIS ADVERSE EVENT SHOULD BE CONSIDERED DUE TO THE WIDESPREAD APPLICATION OF DRUG-ELUTING BALLOONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637338 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention