BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3203253 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04165
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2009
    Report Date
    June 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ARE NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ARE NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. PATIENT AGE ESTIMATED AS 60 YEARS OLD. (REPORTED AGES: 32 - 84 YEARS). PATIENT GENDER ESTIMATED AS MALE. (REPORTED GENDERS: 94 MEN AND 71 WOMEN). DATE OF EVENT AND THERAPY ESTIMATED. THE ARTICLE INDICATES THE PROCEDURES WERE PERFORMED BETWEEN JANUARY 2009 AND MARCH 2012. OTHER RELEVANT HISTORY: HEPATOCELLULAR CARCINOMA (124, 75.2%), INTRAHEPATIC CHOLANGIOCARCINOMA (11, 6.7%), METASTATIC TUMOURS (30, 18.2%) INCLUDING PANCREATIC, COLORECTAL, PULMONARY, GENITOURINARY TUMOURS, SARCOMA, AND MELANOMA. Z. WANG; X. LI; J. CHEN; H. SHI; J. PAN; X. ZHANG; Z. JIN. (CLINICAL RADIOLOGY XXX (2013)): SAFETY AND EFFECTIVENESS OF REPEAT ARTERIAL CLOSURE USING THE STARCLOSE VASCULAR CLOSURE DEVICE IN PATIENTS WITH HEPATIC MALIGNANCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A RETROSPECTIVE ANALYSIS OF PATIENTS WITH HEPATIC MALIGNANCY WHO HAD UNDERGONE ARTERIAL CLOSURE WITH THE STARCLOSE DEVICE WAS PERFORMED IN PEKING UNION MEDICAL COLLEGE HOSPITAL BETWEEN JANUARY 2009 AND MARCH 2012. THE PURPOSE OF THE PRESENT STUDY WAS TO RETROSPECTIVELY EVALUATE THE SAFETY AND EFFECTIVENESS OF REPEATED USE OF THE STARCLOSE DEVICE FOR VASCULAR CLOSURE IN PATIENTS WITH HEPATIC MALIGNANCY. THERE WERE A TOTAL OF 593 CLOSURES USING THE STARCLOSE DEVICE IN 165 PATIENTS WHO UNDERWENT TRANSARTERIAL CHEMOEMBOLIZATION (TACE), INCLUDING 194 (32.7%) SINGLE CLOSURES AND 399 (67.3%) REPEAT CLOSURES. THE NUMBER OF REPEAT CLOSURES FOR THE SAME FEMORAL ACCESS RANGED FROM ONE TO NINE, WITH A MEDIAN OF TWO. TIME TO REPEAT CLOSURES RANGED FROM 3 TO 17 WEEKS WITH A MEAN OF 5.6 WEEKS. CLOSURE DEVICES WERE SUCCESSFULLY DEPLOYED IN ALL CASES. HAEMOSTASIS WAS ACHIEVED IN 571 CLOSURES WITH A SUCCESS RATE OF 96.3% (96.9% IN SINGLE CLOSURES AND 96% IN REPEAT CLOSURES). RESIDUAL OOZING FROM THE PUNCTURE SITE OCCURRED IN 22 PATIENTS (SIX PATIENTS IN SINGLE CLOSURES AND 16 PATIENTS IN REPEAT CLOSURES) AND ADDITIONAL MANUAL COMPRESSION WAS APPLIED TO STOP THE OOZING. THERE WAS NO STATISTICAL DIFFERENCE IN HAEMOSTASIS SUCCESS RATE BETWEEN SINGLE AND REPEAT CLOSURES (P = 0.579 ACCORDING TO PEARSON'S X2 TEST). THREE PATIENTS WHO UNDERWENT STARCLOSE DEVICE CLOSURES (ONE IN SINGLE CLOSURES AND TWO IN REPEAT CLOSURES) DEVELOPED SMALL HAEMATOMAS THAT RESOLVED SPONTANEOUSLY WITHOUT TREATMENT. NO MAJOR COMPLICATIONS OCCURRED DURING FOLLOW-UP IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302875 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATHS: 5-FRENCH