BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2233604 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06150
    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 SYMPTOMATIC HIGH-GRADE STENOSIS OF THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WAS DESCRIBED TO HAVE MODERATE VESSEL CALCIFICATION. THE PROXIMAL SFA STENOSIS WAS ATTRIBUTED TO MISTAKEN SFA ANTEGRADE PUNCTURE, DUE TO THE VERY HIGH FEMORAL BIFURCATION (ABOVE THE MIDDLE PART OF THE FEMORAL HEAD). THE SFA WAS REPORTEDLY OF RELATIVELY SMALL CALIBER THAT PROBABLY CONTRIBUTED TO THE INTIMAL INJURY DURING ANCHOR RETRACTION. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. A RELATIONSHIP BETWEEN THE PATIENT EFFECT AND THE PRODUCT COULD NOT BE ESTABLISHED. HOWEVER, IT WAS REPORTED THAT A SFA ANTEGRADE PUNCTURE WAS DONE. THE STARCLOSE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE THE STARCLOSE VASCULAR CLOSURE SYSTEM IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, SINCE SUCH PUNCTURE SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION, OR AN ACUTE VESSEL CLOSURE. THEREFORE, THE LIKELY CAUSE FOR THE REPORTED STENOSIS AND CLAUDICATION IS DEVIATION FROM THE IFU. A REVIEW OF THE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE REVIEW OF THE EVENT, 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). THE ARTICLE INDICATES THAT THE MAJOR COMPLICATIONS OCCURRED IN THE EARLY STAGES OF THEIR LEARNING CURVE; IN ADDITION TO LOWER SKILL LEVELS, THEY WERE RELATED TO HIGH PUNCTURE (AT THE LEVEL OF DISTAL INFERIOR EPIGASTRIC ARTERY) AND MULTIPLE PUNCTURE SITE ATTEMPTS AFFECTING BOTH THE ANTERIOR AND POSTERIOR VESSEL WALLS. 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)(DO NOT DEPLOY THE STARCLOSE IN THE SFA). 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 STARCLOSE DEVICE IS NOT INDICATED IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, SINCE SUCH PUNCTURES SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION, OR AN ACUTE VESSEL CLOSURE (THROMBOSIS OF SMALL ARTERY LUMEN). ATTACHMENT, 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 PUNCTURES. A SYMPTOMATIC HIGH-GRADE STENOSIS OF THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OCCURRED. THIS NON-OBESE MALE PATIENT'S VESSEL CALCIFICATION WAS DESCRIBED AS MODERATE. THE VESSEL DIAMETER WAS 5 MM. THE PROXIMAL SFA STENOSIS WAS ATTRIBUTED TO MISTAKEN SFA ANTEGRADE PUNCTURE DUE TO THE VERY HIGH FEMORAL BIFURCATION (ABOVE THE MIDDLE PART OF THE FEMORAL HEAD). THE SFA WAS OF RELATIVELY SMALL CALIBER THAT PROBABLY CONTRIBUTED TO INTIMAL INJURY DURING ANCHOR RETRACTION. THE STENOSIS WAS TREATED WITH PERCUTANEOUS BALLOON ANGIOPLASTY. THE AUTHORS BELIEVE THAT THE STARCLOSE ALSO CAUSED THE STENOSIS AS THE LESION WAS NOT PRESENT IN THE FINAL ANGIOGRAM BEFORE THE DEPLOYMENT OF THE CLIP. THE STENOSIS WAS DETECTED DUE TO CLINICALLY SIGNIFICANT RELAPSE OF INTERMITTENT CLAUDICATION, AND THEREFORE, THE RE-INTERVENTION WAS PERFORMED SOON AFTER THE DIAGNOSIS (1-2 WEEKS AFTER THE DIAGNOSTIC ANGIOGRAPHY). 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.

    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