BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1801282 · Received August 11, 2010

    Report

    Report Number
    2953200-2010-01530
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS AND CONCLUSIONS: THE PT'S BLOOD PRESSURE WAS NOT LOWERED, PRIOR TO TREATMENT.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM THORACIC ANEURYSM. PRIOR TO THE STENT GRAFT IMPLANT THERE WAS A COIL EMBOLIZATION PERFORMED AT THE LSA, AND BYPASS SURGERY BETWEEN CAROTID TO CAROTID. IT WAS REPORTED THAT A TALENT 3434 STENT GRAFT WAS IMPLANTED PROXIMALLY AT THE OSTIUM OF INNOMINATE ARTERY, HOWEVER, DUE TO PT'S BLOOD PRESSURE THE STENT GRAFT WAS PUSHED DOWN TO THE DISTAL END OF THE THORACIC ANEURYSM (MFR# 2953200-2010-01528). THE PT'S BLOOD PRESSURE WAS LOWERED BY ATP, AND THE PHYSICIAN PLACED A TALENT 3636 STENT GRAFT PROXIMALLY TO THE TF3434. DURING EXPANDING AND POSITIONING OF TF3636 STENT GRAFT, AND BEFORE COMPLETE DEPLOYMENT, THERE WAS A RETURN OF SPONTANEOUS CIRCULATION, SO TF3636 MOVED DISTALLY AND THE ANEURYSM WAS NOT SEALED (MFR# 2953200-2010-01529). ANOTHER PHYSICIAN ASSISTED AND ONCE AGAIN THE PT'S BLOOD PRESSURE WAS LOWERED BY ATP, AND AN ATTEMPT TO PLACE A TALENT 3838 STENT GRAFT PROXIMALLY TF3636. DURING THE REMOVAL OF THE TF3838, THE GAP BETWEEN THE TAPERED TIP AND THE EDGE OF OUTER SHEATH OF DELIVERY CATHETER WAS CAUGHT ON THE APEX STENT OF THE EXISTING IMPLANTED TALENT 3636 STENT GRAFT. THE PHYSICIAN EXCHANGED THE GUIDEWIRE, HOWEVER, STILL WAS UNABLE TO ADVANCE THE DEVICE TO THE INTENDED LANDING ZONE. THE PHYSICIAN ELECTED TO PULL THE STENT GRAFT DISTALLY AND PLACE THE TF3838 STENT GRAFT AT AN UNINTENDED LOCATION. THE PHYSICIAN INSERTED ANOTHER MFR'S STENT GRAFT ADVANCING IT THROUGH THE PREVIOUSLY PLACED TALENT 3636 AND TALENT 3434. THE OTHER MFR'S STENT GRAFT WAS PLACED PROXIMAL TO THE TF3636 DEVICE, HOWEVER, THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PLACED A TALENT 3434 STENT GRAFT PROXIMALLY TO AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention