BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2233605 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06153
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    January 1, 2004
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS COULD NOT BE PERFORMED ON THE PRODUCT BECAUSE IT WAS NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. THE REPORTED PSEUDOANEURYSM OCCURRED AFTER ANTEGRADE PUNCTURE IN A HEAVILY CALCIFIED VESSEL. THE REPORTED PSEUDOANEURYSM CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE, AND/OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING EACH DEVICE IS INSPECTED TO ENSURE PRODUCT QUALITY AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. USER TECHNIQUE, SUCH AS INADEQUATE NICK AND SPREAD INCISION, IMPROPER SEATING OF THE CLIP DELIVERY TUBE ON TOP OF THE ACCESS SITE, NOT MAINTAINING DOWNWARD PRESSURE AND DEVICE STABILITY WHILE DEPRESSING THE DEPLOYMENT BUTTON WITH THE RIGHT THUMB, INCORRECT ANGLE OF THE DEVICE DURING CLIP DEPLOYMENT, AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT MAY CONTRIBUTE TO THE REPORTED PSEUDOANEURYSM. PATIENT ANATOMY (E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY ALSO CONTRIBUTE TO THE REPORTED EXPERIENCE. IT WAS REPORTED THAT THE VESSEL OF THE PATIENT WAS HEAVILY CALCIFIED, WHICH IS LISTED UNDER PRECAUTIONS IN THE STARCLOSE INSTRUCTIONS FOR USE (IFU), INSTRUCTING TO NOT DEPLOY THE CLIP IN CALCIFIED AREAS. THEREFORE, THE LIKELY CAUSE FOR THE REPORTED EVENT IS DEVIATION FROM THE IFU. REVIEW OF THE DEVICE HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE WERE NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE REVIEW OF THE EVENT INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(6). (DATE OF EVENT): THE PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2004 AND (B)(6) 2009. THE DATE FOR THIS INDIVIDUAL CASE IS NOT KNOWN. (B)(6). PLACEMENT OF THE STARCLOSE DEVICE WAS PERFORMED BY SENIOR INTERVENTIONAL RADIOLOGISTS OR EXPERIENCED FELLOWS AFTER ADEQUATE TRAINING. A 6 FR. SHEATH SIZE WAS USED DURING THE PROCEDURE. THE ARTICLE INDICATES THAT THE MAJOR COMPLICATIONS OCCURRED IN THE EARLY STAGES OF THEIR LEARNING CURVE; IN ADDITION TO LOWER SKILL LEVELS. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: SHEATH: 6 FR; OTHER: CLOPIDOGREL, ASPIRIN, HEPARIN. (B)(4)- IMPROPER OR INCORRECT METHOD (DO NOT DEPLOY THE STARCLOSE CLIP IN AREAS OF CALCIFIED PLAQUE). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH RELEVANT INFORMATION. THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. ARTICLE: SAFETY AND EFFICACY OF THE STARCLOSE VASCULAR CLOSURE DEVICE IN MORE THAN 1000 CONSECUTIVE PERIPHERAL ANGIOPLASTY PROCEDURES. STAVROS SPILIOPOULOS, MD, PHD, ET AL; J ENDOVASC THER 2011; 18:435-443. (B)(6).

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOTED DURING A LARGE SINGLE-CENTER RETROSPECTIVE STUDY REVIEW (FROM (B)(6) 2004 AND (B)(6) 2009). THE HOSPITAL DATABASE WAS SEARCHED AND 850 PATIENTS WERE COMPARED TO IDENTIFY THE SAFETY AND EFFICACY OF THE STARCLOSE EXTRAVASCULAR CLOSURE DEVICE IN ACHIEVING HEMOSTASIS FOLLOWING A VARIETY OF THERAPEUTIC PERCUTANEOUS PERIPHERAL PROCEDURES USING ANTEGRADE (588) OR RETROGRADE (625) COMMON FEMORAL ARTERY (CFA) PUNCTURES. A PUNCTURE SITE PSEUDOANEURYSM AFTER ANTEGRADE PUNCTURE IN A HEAVILY CALCIFIED VESSEL IN A MALE PATIENT OCCURRED. THE PSEUDOANEURYSM WAS FORMED AFTER THE DEPLOYMENT OF THE NITINOL CLIP. THE PSEUDOANEURYSM WAS TREATED USING ULTRA-SOUND (U/S)-GUIDED THROMBIN INJECTION. THE AUTHOR BELIEVES THAT THE FAILED IMMEDIATE HEMOSTASIS WITH THE STARCLOSE, THE ANTEGRADE PUNCTURE, AS WELL AS THE HEAVILY CALCIFIED VESSEL ATTRIBUTED TO THE PSEUDOANEURYSM FORMATION. IN RETROSPECT, IN THIS PARTICULAR CASE THE OPERATOR SHOULD HAVE PROBABLY APPLIED ADDITIONAL MANUAL COMPRESSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention