BEUDAMED
    FDA Adverse Event Death Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2040824 · Received March 30, 2011

    Report

    Report Number
    2182269-2011-00055
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THE EXACT LOT NUMBER WAS UNKNOWN; HOWEVER THE CUSTOMER REPORTED THAT THE PRODUCT MAY HAVE BEEN FROM ONE OF THREE LOTS, 3170405, 3178653, OR 3198787. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE SUBJECT BATCHES (3170405, 3178653 AND 3198787) ALL MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE MFG AND USE BY DATES ARE AS FOLLOWS: BATCH NO. 3170405: MFG DATE: 07/01/2010; USE BY: 06/30/2011. BATCH NO. 3178653: MFG DATE: 08/01/2010; USE BY 07/31/2011. BATCH NO. 3198787: MFG DATE: 09/01/2010; USE BY: 08/31/2011. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR AN ACUTE MYOCARDIAL INFARCTION (AMI) PT, AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. AN 8F TERUMO SHEATH WAS USED DURING THE PCI PROCEDURE. NO PREDEPLOYMENT ANGIOGRAM WAS PERFORMED, HOWEVER THE PUNCTURED ARTERY WAS REPORTEDLY IN THE COMMON FEMORAL ARTERY (CFA). APPROX 6 HOURS AFTER THE ANGIO-SEAL WAS DEPLOYMENT, THE PT DEVELOPED SYMPTOMS OF THE LOWER EXTREMITY ISCHEMIA. AN ANGIOGRAM REVEALED A VESSEL OCCLUSION. THE OCCLUDED ARTERY WAS DILATED WITH BALLOON ANGIOPLASTY. AFTER THE PROCEDURE, BLEEDING WAS OBSERVED FROM THE PUNCTURE SITE. THE PT'S CONDITION WAS UNSTABLE AFTER THE PCI, AND DETERIORATED AFTER THE PERCUTANEOUS PERIPHERAL INTERVENTION (PPI). THE PT WENT INTO SHOCK AND DIED (DATE UNK). NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| R