BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2233581 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06149
    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 THEY WERE NOT RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. HEMOSTASIS FAILURE OR FAILURE TO DEPLOY THE CLIP ON THE ARTERIAL WALL CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE AND/OR PATIENT ANATOMICAL CONDITIONS. EACH DEVICE IS INSPECTED TO HELP ENSURE PRODUCT QUALITY AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, INCLUDING PROPER CLIP PLACEMENT IN A TISSUE MODEL, 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, WHICH SHOULD BE 60-75 DEGREES, AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT MAY CAUSE THE CLIP TO NOT DEPLOY. PATIENT ANATOMY (E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY ALSO CONTRIBUTE TO THE REPORTED EXPERIENCE. REPORTEDLY, HEMOSTASIS FAILURE WAS MAINLY RELATED TO ANTEGRADE PUNCTURE IN OBESE PATIENTS AND/OR HEAVILY CALCIFIED VESSELS. THE STARCLOSE INSTRUCTIONS FOR USE (IFU) STATES: THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WHO ARE MORBIDLY OBESE. THE IFU FURTHER INDICATES: DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO DELIVER THE CLIP ON THE EXTERNAL ARTERIAL WALL COULD NOT BE DETERMINED. IT IS LIKELY THAT THE REPORTED EXPERIENCED OCCURRED DUE TO DEVIATION FROM THE IFU. A REVIEW OF THE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE WERE NOT PERFORMED BECAUSE THE DEVICE LOT NUMBERS WERE NOT REPORTED. BASED ON THE REVIEW OF THE EVENTS 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. HEMOSTASIS FAILURE WAS MAINLY RELATED TO ANTEGRADE PUNCTURE IN OBESE PATIENTS AND/OR HEAVILY CALCIFIED VESSELS AND SMALL TECHNICAL INACCURACIES REGARDING CLIP DEPLOYMENT. DESPITE OF THE EXTENSIVE OFF-LABEL USE OF THE DEVICE AFTER MULTIPLE AND POSTERIOR WALL PUNCTURES AND FOLLOWING PLACEMENT OF A 7-OR-8 FR SHEATH, THE OVERALL MAJOR COMPLICATION RATE WAS INDICATED AS LOW. THE APPLICATION OF THE DEVICE IN REPEAT REVASCULARIZATION PROCEDURES DUE TO CLINICAL RELAPSE OF THE DISEASE DID NOT CAUSE ANY ADDITIONAL PROCEDURAL DIFFICULTY OR INCREASED TECHNICAL FAILURE RATE. IN FEW OF THE PROCEDURES PERFORMED DURING (B)(6) 2009 THE STARCLOSE SE WAS USED. HOWEVER, NONE OF THE MAJOR COMPLICATIONS REPORTED REGARDED THE UPGRADED VERSION OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: SHEATH: 6 FR., 7 FR., 8 FR.; OTHER: CLOPIDOGREL, ASPIRIN, HEPARIN. SIX FR (1165 PATIENTS), 7 FR (39 PATIENTS), 8 FR (9 PATIENTS). (B)(4)- IMPROPER OR INCORRECT METHOD (SHEATH SIZE GREATER THAN 6 FR.) (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. DO NOT USE THE STARCLOSE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, SINCE SUCH PUNCTURES MAY RESULT IN A RETROPERITONEAL HEMATOMA. THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH INTRODUCER SHEATHS SMALLER THAN 5FR OR GREATER THAN 6FR DURING CATHETERIZATION PROCEDURES. 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 EVENTS WERE 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 PUNCTURES. THE STARCLOSE DEVICE WAS APPLIED MORE THAN ONCE IN THE SAME FEMORAL ARTERY OF 124 LIMBS DURING DIFFERENT ANGIOPLASTY SESSIONS. ONE HUNDRED THIRTY TWO BILATERAL PUNCTURES WERE PERFORMED IN THE SAME SESSION (PER PATIENT) IN ORDER TO TREAT BOTH LEGS. OVERALL HEMOSTASIS SUCCESS WAS ACHIEVED IN 1139 (OF 1213) CASES/PUNCTURES. IN 237 OF THE TECHNICALLY SUCCESSFUL CASES (1139), ADDITIONAL SUPPORTIVE COMPRESSION FOR LESS THAN 5 MINUTES WAS NECESSARY DUE TO IMMEDIATE VESSEL OOZING. SEVENTY FOUR CASES REQUIRED PROLONGED STANDARD (ARTERIAL) COMPRESSION BECAUSE OF HEMOSTASIS FAILURE; OF THESE, 13 CASES WERE DUE TO FAILURE TO DELIVER THE CLIP ON THE ARTERY'S EXTERNAL WALL. A TOTAL OF 4 MAJOR COMPLICATIONS OCCURRED AND 64 MINOR COMPLICATIONS; LATE OOZING/MINOR BLEEDING AT LEAST HALF AN HOUR UP TO 3 HOURS AFTER SUCCESSFUL CLIP DEPLOYMENT= 23, GROIN MINOR HEMATOMA = 41. THE MAJOR COMPLICATIONS WILL BE FILED INDIVIDUALLY IN SEPARATE ADDITIONAL REPORTS. IMMEDIATE SHEATH REMOVAL WAS PERFORMED AFTER COMPLETION OF THE PERIPHERAL ANGIOPLASTY PROCEDURE IRRESPECTIVE OF THE TOTAL DOSE OF HEPARIN GIVEN.

    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 Hospitalization| R