BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2190645 · Received July 22, 2011

    Report

    Report Number
    2182269-2011-00119
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PATIENTS HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES >5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION USING OF THE ANGIO-SEAL DEVICE IF THERE IS SUSPICION THAT THE INTRODUCER HAS BEEN PLACED THROUGH THE SUPERFICIAL FEMORAL ARTERY AND INTO THE PROFUNDA FEMORIS. COLLAGEN DEPOSITION INTO THE SUPERFICIAL FEMORAL ARTERY COULD RESULT, WHICH MAY REDUCE THE BLOOD FLOW THROUGH THE VESSEL. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR CLOSURE ON A PATIENT FOLLOWING A HEART CATHETERIZATION, CEREBRAL ANGIOGRAPHY, AND CORONARY STENT PLACEMENT IN THE RIGHT CORONARY AND CIRCUMFLEX ARTERIES ON (B)(6) 2011. A FEMORAL ANGIOGRAM WAS PERFORMED UNDER FLUOROSCOPY WITHOUT A CINE RUN TO DETERMINE IF THE PATIENT WAS A SUITABLE CANDIDATE FOR A VASCULAR CLOSURE DEVICE. THE ANGIO-SEAL WAS PLACED IN THE RIGHT FEMORAL ARTERY WITHOUT COMPLICATION ACCORDING TO THE CATHETERIZATION PROCEDURE REPORT. THE PATIENT RETURNED TO THE CATHETERIZATION LAB ON (B)(6) 2011 TO HAVE AN ABDOMINAL AORTIC ANGIOGRAM AND BILATERAL LOWER EXTREMITY ANGIOGRAM PERFORMED FOR THE INDICATION OF PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION. THE IMPRESSION FROM THIS PROCEDURE NOTED THAT THERE WAS A TOTAL OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY AT THE SITE OF THE PREVIOUS ANGIO-SEAL PLACEMENT. IT WAS ALSO NOTED THAT THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS TOTALLY OCCLUDED IN THE MIDSEGMENT WHICH RECONSTITUTED DISTALLY VIA COLLATERALS AND THE REST OF THE VASCULAR ANATOMY HAD NON-OBSTRUCTIVE DISEASE. AT THIS TIME, THE PATIENT WAS REFERRED TO VASCULAR SURGERY FOR POSSIBLE FEMORAL ENDARTERECTOMY. ON (B)(6) 2011, SURGERY WAS PERFORMED WITH A PREOPERATIVE DIAGNOSIS OF AN OCCLUDED RIGHT COMMON FEMORAL ARTERY POST CARDIAC CATHETERIZATION WITH ASSOCIATED SEVERE CLAUDICATION IN THE RIGHT LOWER EXTREMITY. THE OPERATION PROCEDURE REPORT NOTED THAT THE PATIENT HAD A RIGHT FEMORAL ARTERY EXPLORATION WITH THROMBECTOMY OF THE RIGHT COMMON FEMORAL ARTERY, EXTERNAL ILIAC ARTERY, WITH CONCOMITANT ENDARTERECTOMY OF THE RIGHT COMMON FEMORAL ARTERY AND PATCH ANGIOPLASTY OF THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT WAS CONSIDERED STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R CARDENE (1.25 MG)| OXYGEN (2 LPM)| ANGIOMAX (21 ML/HR, 44.25 MG)| HEPARIN (5000 UNITS)| PLAVIX (600 MG)| VERSED (4 MG)| ASPIRIN (325 MG)| NITROGLYCERIN (200 MCG)