BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 14323534 · Received May 7, 2022

    Report

    Report Number
    3005168196-2022-00201
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    December 8, 2020
    Report Date
    May 6, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K160533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL ADVERSE EVENTS IN THE LABELING WITH INDIGO SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, VESSEL SPASM, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00202.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 12-APR-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "NEONATAL ARTERIAL THROMBOSIS: TREATMENT VIA A PATENT DUCTUS ARTERIOSUS" (PATEL ET AL. 2021). IN THIS STUDY, TWO PATIENTS WERE TREATED FOR NEONATAL ARTERIAL THROMBOSIS IN THE DESCENDING AORTA, ILIAC, AND RENAL ARTERIES USING INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3). IN ONE NEONATAL CASE, FOLLOWING IMPROVED PATENCY IN THE DESCENDING AORTA AND ILIAC ARTERIES AFTER USE OF THE CAT6, THE CAT3 WAS USED COAXIALLY INSIDE THE CAT6 TO PERFORM THROMBECTOMY IN THE LEFT RENAL ARTERY. DURING THIS TIME, THE PATIENT DEVELOPED PROGRESSIVE ABDOMINAL DISTENTION, DESATURATION, AND CARBON DIOXIDE RETENTION WITH BOTH METABOLIC AND RESPIRATORY ACIDOSIS. ANGIOGRAPHY DID NOT DEMONSTRATE EXTRAVASATION OR FILLING OF THE LEFT RENAL ARTERY. ABDOMINAL ULTRASOUND DEMONSTRATED BOWEL WALL EDEMA. IT BECAME APPARENT THAT THE PATIENT HAD DEVELOPED ABDOMINAL COMPARTMENT SYNDROME SECONDARY TO ACUTE REPERFUSION OF THE ABDOMINAL ORGANS. THE PATIENT HAD A RESPIRATORY ARREST AND RECEIVED CARDIOPULMONARY RESUSCITATION, WHICH WAS DISCONTINUED AFTER DISCUSSION WITH THE FAMILY. AUTOPSY DEMONSTRATED LEFT RENAL ARTERY THROMBOSIS WITHOUT EVIDENCE OF VASCULAR INJURY. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295396 INDIGO SYSTEM ASPIRATION CATHETER 6 QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Male Required Intervention| D