BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK-35

    MDR report key: 14939098 · Received July 6, 2022

    Report

    Report Number
    2134265-2022-07565
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    October 8, 2020
    Report Date
    July 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: PUBLICATION DATE OF ARTICLE USED. INITIAL REPORTER FACILITY NAME: RADIOLOGY DEPARTMENT, NATIONAL LIVER INSTITUTE, MENOUFIA UNIVERSITY INITIAL REPORTER ADDRESS 1: YASSINABDELGHAFFAR ST., SHEBIN AL-KOM, MENOUFIA ALWARRAKY, MOHAMED S., MOHAMED M. ABDALLAH, AND MOHAMED S. ELGHARBAWY. "CLINICAL OUTCOME AND SAFETY OF SELECTIVE RENAL ARTERY EMBOLIZATION USING PERMANENT OCCLUSIVE AGENTS FOR ACUTE RENAL BLEEDING." EGYPTIAN JOURNAL OF RADIOLOGY AND NUCLEAR MEDICINE 51.1 (2020): 1-10.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. TO EVALUATE HOW FAR IS SELECTIVE RENAL ARTERY EMBOLIZATION (RAE) USING PERMANENT AGENTS EFFECTIVE IN TREATING ACUTE RENAL ARTERY BLEEDING. WE RETROSPECTIVELY REVIEWED THE MEDICAL RECORDS OF PATIENTS (N = 45) WITH RENAL BLEEDING WHO WERE MANAGED BY SELECTIVE RAE USING COILS, N-BUTYL-CYANOACRYLATE GLUE (NBCA GLUE), AND POLYVINYL ALCOHOL (PVA). DATA RETRIEVED INCLUDED THE CAUSE, NUMBER, AND TYPE OF THE BLEEDING LESIONS AS WELL AS THE RESULTS OF THE EMBOLIZATION FOR 1 YEAR AFTER RAE. CLINICAL SUCCESS WAS THE PRIMARY OUTCOME WHILE RE-BLEEDING AND COMPLICATIONS WERE THE SECONDARY OUTCOMES. TABLE 3 SHOWS THE CLINICAL OUTCOME AND COMPLICATIONS IN STUDIED PATIENTS. TECHNICAL SUCCESS WAS ACHIEVED IN 100% OF PATIENTS. CLINICAL SUCCESS WAS ACHIEVED IN 41/45 PATIENTS FROM THE FIRST SESSION REPORTING PRIMARY CLINICAL SUCCESS OF 91.1%. ONE PATIENT SHOWED A PARTIAL RESPONSE AS BLEEDING PERSISTED AFTER EMBOLIZATION. MEDICAL TREATMENTS IN THE FORM OF HEMOSTATICS FAILED TO CONTROL THE BLEEDING FOR A WEEK AFTER EMBOLIZATION. THIS PATIENT WAS SUBJECTED TO ANOTHER SESSION OF EMBOLIZATION, AND THE DIAGNOSTIC ANGIOGRAPHY SHOWED LEAKING AROUND THE PREVIOUSLY IMPLANTED UNDERSIZED COIL IN THE PSEUDOANEURYSM. THE FEEDING ARTERY OF THE ANEURYSM WAS RE-PACKED BY ANOTHER COIL SIZED 0.018 TO ENSURE COMPLETE PACKING. OVERALL, THE TOTAL NUMBER OF PATIENTS WITH CLINICAL SUCCESS AFTER THE SECOND SESSION IS 42/45 (93.3%). THREE PATIENTS DID NOT RESPOND TO THE SECOND SESSION EMBOLIZATION. IN THESE PATIENTS, BLEEDING PERSISTED AS THESE LESIONS WERE MULTIPLE. THOSE PATIENTS WERE SUBJECTED TO NEPHRECTOMY. FOR THE SUBGROUP OF COILS (N = 23), THE CLINICAL SUCCESS WAS ACHIEVED IN 21/23 PATIENTS REPORTING PRIMARY CLINICAL SUCCESS OF 91.3%. ON THE OTHER HAND, OR THE SUBGROUP OF NBCA GLUE (N = 15), THE CLINICAL SUCCESS WAS ACHIEVED IN 14/15 PATIENTS REPORTING PRIMARY CLINICAL SUCCESS OF 93.3% WHILE FOR THE PVA SUBGROUP (N = 7), ALL PATIENTS WERE CONTROLLED WITH A CLINICAL SUCCESS RATE OF 100%. WE REPORTED NO SIGNIFICANT DIFFERENCES REGARDING RE-BLEEDING AMONG SUBGROUPS OF ANALYSIS (P > 0.05). REGARDING THE RECURRENCE OF BLEEDING, NONE OF OUR PATIENTS EXPERIENCED RE-BLEEDING FOR 1 YEAR EXCEPT ONE HAVING AN AVM. RE-BLEEDING OCCURRED AFTER 6 MONTHS OF THE EMBOLIZATION. FOR THIS PATIENT, WE OCCLUDED THE PROXIMAL SEGMENT OF THE AVM BECAUSE OF THE RAPID POLYMERIZATION OF NBCA GLUE WITH RAPID THROMBOSIS. DIAGNOSTIC ANGIOGRAPHY FOR THIS PATIENT SHOWED MULTIPLE COLLATERALS THAT SUPPLIED THE AVM. RAE WAS UNSUCCESSFUL. SPECIFICALLY, AS FOR THE COIL SUB-GROUP, WE SUCCESSFULLY USED COILS IN 23 PATIENTS REPRESENTING (51.1%). ALL COILS WERE OF DETACHABLE DELIVERY TECHNIQUE AND FIBERED SURFACE BENEFITING OF ITS ADVANTAGE OF CONTROLLED AND ACCURATE POSITIONING AS WELL AS STRONG OCCLUSIVE EFFECTS. THE MAIN DISADVANTAGE OF USING COILS IS THAT MORE THAN ONE COIL IS USUALLY NEEDED FOR PROPER OCCLUSION INCREASING THE COST AND TIME OF THE PROCEDURE OR ADDITIONAL EMBOLIC MAY BE ADDED [19]. HAOCHEN ET AL. USED PUSHABLE COILS TO TREAT BLEEDING AFTER BIOPSY. IN ALL PATIENTS, THEY USED ADDITIONAL GEL FOAM TO EFFICIENTLY OCCLUDE THE LESION [17]. IN OUR STUDY, WE FOUND THAT DETACHABLE FIBERED COILS ARE EFFECTIVE AS WE DID NOT USE ADDITIONAL AGENTS. THIS MAY BE DUE TO THE LONGER LENGTH OF THE DETACHABLE COIL COMPARED TO PUSHABLE. WE USED TWO COILS IN ONE PATIENT WHEN TOTAL OCCLUSION COULD NOT BE ACHIEVED. ONE IMPORTANT COMPLICATION IS THE COIL MAL-POSITION THAT OCCURRED IN ONE OF OUR PATIENTS WITH NO CLINICAL SIGNIFICANT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422849 INTERLOCK-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown