BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK-35

    MDR report key: 14918305 · Received July 5, 2022

    Report

    Report Number
    2134265-2022-07446
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    January 13, 2020
    Report Date
    July 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE OF PUBLICATION USED. INITIAL REPORTER FACILITY NAME: (B)(6). LEE, BYUNG CHAN, ET AL. "ENDOVASCULAR TREATMENT OF WIDE-NECKED ANEURYSMS OF THE VISCERAL AND RENAL ARTERIES USING THE DOUBLE MICROCATHETER TECHNIQUE VIA A SINGLE ACCESS ROUTE." DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY 26.5 (2020): 476.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT RENAL ISCHEMIA OCCURRED. NINE PATIENTS (MEAN AGE, 58 YEARS; AGE RANGE, 42 TO 69 YEARS; 4 MEN, 5 WOMEN) WITH WIDE-NECKED VRAAS WHO UNDERWENT TREATMENT WITH THE DOUBLE MICROCATHETER TECHNIQUE FROM JANUARY 2016 TO JULY 2018 WERE INCLUDED IN THE STUDY. FOR ALL PATIENTS, ANATOMICAL FEATURES WERE CONFIRMED USING CONE-BEAM COMPUTED TOMOGRAPHY (CT) WITH ROTATIONAL ANGIOGRAPHY. THE ANEURYSMAL LOCATION, SIZE, VOLUME, NECK-TO-DOME RATIO, NUMBER OF COILS USED, AND COIL PACKING DENSITY WERE INVESTIGATED. TECHNICAL SUCCESS, COMPLICATIONS (COIL MIGRATION AND ORGAN ISCHEMIA), CHANGES IN THE COMPLETE BLOOD COUNT OR SERUM CREATINE LEVEL, AND RECURRENCE WERE ALSO EVALUATED. THREE RENAL ARTERY ANEURYSMS AND 6 SPLENIC ARTERY ANEURYSMS WERE TREATED BY THE DOUBLE MICROCATHETER TECHNIQUE. THE MEAN SIZE OF THE ANEURYSMS WAS 26.09-4.76 MM, MEAN VOLUME WAS 6.19-3.69 CM3, AND MEAN NECK-TO-DOME RATIO WAS 1.53-0.24. THE NUMBER OF COILS USED RANGED FROM 7 TO 16. THE MEAN PACKING DENSITY WAS 11.32%-3.72%. TECHNICAL SUCCESS WAS ACHIEVED IN ALL 9 PATIENTS. RENAL ISCHEMIA OCCURRED IN TWO PATIENTS WITH RENAL ARTERY ANEURYSM, ONE OF WHOM SHOWED MINIMAL SCAR FORMATION ON FOLLOW-UP CT AFTER INFARCTION. NO COIL MIGRATIONS OR DISEASE RECURRENCES WERE OBSERVED. THE TECHNICAL SUCCESS RATE WAS 100%. TWO PATIENTS DEVELOPED MINOR COMPLICATIONS AFTER THE PROCEDURE. ONE PATIENT (CASE 6) EXHIBITED RENAL ISCHEMIC CHANGES ON FOLLOW-UP CT IMAGING PERFORMED 1 WEEK LATER, WITH THE ABSENCE OF CLINICAL SYMPTOMS. THE SERUM CREATINE LEVEL BEFORE TREATMENT WAS 0.8 MG/DL (NORMAL RANGE, 0.5 TO 1.3 MG/DL), WHILE THOSE IMMEDIATELY AND 1 MONTH AFTER TREATMENT WERE 0.9 AND 0.8 MG/DL, RESPECTIVELY. THE PARENCHYMAL ISCHEMIC CHANGES RESOLVED TO A MINOR CORTICAL SCAR ON THE 6-MONTH FOLLOW-UP CT IMAGES (FIG. 3). ONE PATIENT (CASE 7) EXHIBITED TWO ANEURYSMS IN THE LEFT RENAL ARTERY, ONE OF WHICH HAD A WIDE NECK. THE WIDE-NECKED ANEURYSM WAS TREATED USING THE DOUBLE MICROCATHETER TECHNIQUE, WHILE THE OTHER LESION WAS TREATED WITH CONVENTIONAL COIL PACKING USING A SINGLE MICROCATHETER. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF INTERMITTENT PAIN IN THE LEFT FLANK FOR 6 DAYS, AND THE INITIAL FOLLOW-UP CT IMAGE REVEALED PARTIAL RENAL INFARCTION. THE SERUM CREATINE LEVELS BEFORE, IMMEDIATELY AFTER, AND 1 MONTH AFTER TREATMENT WERE 0.6, 0.6 MG/DL, AND 0.8 MG/DL, RESPECTIVELY. THE PATIENT DID NOT UNDERGO ADDITIONAL IMAGING STUDIES, AND HER CLINICAL SYMPTOMS IMPROVED DURING THE HOSPITAL STAY. FOLLOW-UP CT DID NOT SHOW A REMNANT ANEURYSMAL SAC OR RECURRENCE IN ANY THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482019 INTERLOCK-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other