BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3172890 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03769
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE STARCLOSE INSTRUCTIONS FOR USE, SPECIAL PATIENT POPULATIONS SECTION STATES THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY ENCOUNTERED REMOVING THE DEVICE WAS CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT INDICATED DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, THE DEVICE WAS USED IN A HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY. THE STARCLOSE SE DEVICE INSTRUCTIONS FOR USE (IFU) UNDER PRECAUTIONS STATES THAT THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. IN ADDITION, THE IFU STATES DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. REPORTEDLY, ACCESS OF THE VESSEL WAS DESCRIBED AS A HIGH STICK. THE IFU STATES UNDER THE WARNING SECTION NOT TO USE THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. REPORTEDLY, THE PATIENT WAS MORBIDLY OBESE. THE IFU STATES UNDER SPECIAL PATIENT POPULATION SECTION THAT THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WHO ARE MORBIDLY OBESE (BODY MASS INDEX GREATER THAN 35 KG/M2).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY ANGIOGRAM, ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED AND SCARRED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING OF THE ACCESS SITE CONTINUED AND DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. THE DEVICE WAS REMOVED BY PULLING IT OUT FROM THE VESSEL WITHOUT USING THE SAFETY RELEASE. FURTHER ANGIOGRAPHY REVEALED A PSEUDOANEURYSM AT THE ACCESS SITE AND THAT THE PUNCTURE HAD BEEN MADE THROUGH AN EXISTING STENT THAT WAS NOT INITIALLY VISUALIZED DUE TO THE USE OF LOW LEVEL RADIATION ON THE INITIAL FEMORAL ANGIOGRAM. THE VESSEL WAS SURGICALLY REPAIRED AND SUTURED TO ACHIEVE HEMOSTASIS. HOSPITALIZATION WAS EXTENDED FOR TWO DAYS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2013 CARDIAC INTERVENTIONAL CATHETERIZATION WAS PERFORMED WITH ANGIOMAX ADMINISTERED. AFTER THE STARCLOSE SE DEVICE FAILED A NON-ABBOTT MECHANICAL COMPRESSION DEVICE WAS APPLIED AT THE ACCESS SITE. A COMPUTED TOMOGRAPHY SCAN REVEALED THE PRESENCE OF A RETROPERITONEAL HEMATOMA WITH BLEEDING. AN ULTRASOUND OF THE RIGHT FEMORAL ARTERY THAT NOTED THE PRESENCE OF A PSEUDOANEURYSM WITH ACTIVE BLEEDING. EMERGENT RIGHT FEMORAL ARTERY REPAIR WAS PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, A USER FACILITY MEDWATCH REPORT WAS RECEIVED THAT STATES "STARCLOSE FAILURE TO CLOSE FEMORAL ARTERY. STARCLOSE WAS USED AFTER CATHETERIZATION TO OBTAIN HEMOSTASIS. CLIP PARTIALLY DEPLOYED AND WHEN DEVICE WAS RETRACTED FROM THE BODY BY PHYSICIAN, BLOOD TISSUE NOTED ON END OF DEVICE. ANOTHER DEVICE WAS USED TO CLOSE THE ARTERY. NO PATIENT HARM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? STARCLOSE AFTER CATHETERIZATION TO OBTAIN HEMOSTASIS." THE INITIAL REPORTER WAS CONTACTED, WHO CONFIRMED THE ADDITIONAL INFORMATION PROVIDED ON THE INITIAL REPORT WAS CORRECT AND THOROUGHLY DOCUMENTS THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273478 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30419K1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R SHEATH: 6-FRENCH| ANGIOMAX