BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3728517 · Received April 7, 2014

    Report

    Report Number
    2953200-2014-00657
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    October 7, 2012
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED (MODIFYING THE STENT GRAFT).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: SCALLOP TECHNIQUE OF URGENT ENDOVASCULAR REPAIR FOR SYMPTOMATIC THORACOABDOMINAL AORTIC ANEURYSM WITH A READY-MADE DEVICE. MASASHI KAWAMURA, TORU KURATANI, YUKITOSHI SHIRAKAWA, KEI TORIKAI, KAZUO SHIMAMURA, KEIWA KIN, AND YOSHIKI SAWA. ANN VASC SURG 2013; 27: 239.E5E239.E8. MANUSCRIPT ACCEPTED: (B)(6) 2012, A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 9 CM THORACIC AORTA ANEURYSM. THE CELIAC ARTERY WAS INVOLVED IN THE ANEURYSM AND OCCLUDED PRIOR TO INSERTION OF THE STENT GRAFT. THE ENTIRE TAPERED DEVICE WAS UNSHEATHED, AND A V-SHAPED SCALLOP WAS CREATED BETWEEN THE BOTTOM STENT STRUTS TO PRESERVE PERFUSION OF THE SMA. RADIOPAQUE MARKERS, WHICH WERE ATTACHED TO THE TALENT STENT GRAFT, WERE USED TO ASSIST WITH ORIENTATION DURING DEPLOYMENT. TWO OF THE THREE FIGURE-8 RADIOPAQUE MARKERS ON THE DISTAL END OF THE STENT GRAFT WERE DETACHED AND REATTACHED AT BOTH SIDES OF THE SCALLOP AT DIFFERENT HEIGHTS TO AID CORRECT ORIENTATION. ANGIOGRAPHY CONFIRMED PRESERVATION OF THE SMA FLOW, BUT A DISTAL TYPE I ENDOLEAK WAS DETECTED. A PALMAZ XL STENT WAS IMPLANTED JUST PROXIMAL TO THE ORIFICE OF THE SMA AND THE TYPE I ENDOLEAK DISAPPEARED. THERE IS NO FURTHER INFORMATION AVAILABLE. A (B)(6) WOMAN HAD A LARGE THORACOABDOMINAL AORTIC ANEURYSM (TAAA) WITH ABDOMINAL PAIN. THIS ANEURYSM INVOLVED THE CELIAC ARTERY AND THE SUPERIOR MESENTERIC ARTERY (SMA). THE RISK OF OPEN SURGERY WAS VERY HIGH DUE TO SEVERE COMORBIDITY, AND THERE WAS NO APPROPRIATE DISTAL ATTACHMENT FOR THORACIC ENDOVASCULAR REPAIR (TEVAR) WITH READY-MADE DEVICES. THEREFORE, TEVAR WITH THE SCALLOP TECHNIQUE WAS PERFORMED IN THIS URGENT SETTING. A SCALLOP WAS CREATED IN A TALENT THORACIC STENT GRAFT. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED, AND PERFUSION IN THE SMA WAS PRESERVED USING THIS SCALLOPED ENDOGRAFT. THE SCALLOP TECHNIQUE WITH A READYMADE DEVICE MAY BE ONE OF THE TREATMENT OPTIONS FOR URGENT TAAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207153 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention