BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3475104 · Received November 18, 2013

    Report

    Report Number
    1058196-2013-00313
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    August 1, 2013
    Report Date
    October 25, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE PATIENT HAD ASYMPTOMATIC INTRACRANIAL HEMORRHAGE AFTER TEB USAGE OF AN UNKNOWN ENTERPRISE STENT (ENF452812 / UNK). LITERATURE ARTICLE REVIEW: RECANALIZATION OF ACUTE INTRACRANIAL ARTERY OCCLUSION USING TEMPORARY ENDOVASCULAR BYPASS TECHNIQUE, AUTHORED BY SANG HYUN SUH, MD., KYUNG-YUL, LEE, MD., KWON DUK SEO, MD., SOO MEE LIM, MD ., HONG GEE ROH, MD., BYUNG MOON KIM, MD. PURPOSE: THE PURPOSE OF THIS STUDY IS TO PRESENT OUR PRELIMINARY EXPERIENCE OF THE TEMPORARY ENDOVASCULAR BYPASS (TEB) TECHNIQUE USING AN ENTERPRISE STENT FOR RECANALIZATION OF ACUTE INTRACRANIAL ARTERY (IA) OCCLUSION. CONCLUSION: TEB MAY BE A VALUABLE TREATMENT OPTION IN ACUTE THROMBOEMBOLIC IA OCCLUSION WITHOUT STENT IMPLANTATION. ELEVEN PATIENTS WERE ENROLLED IN THIS STUDY (8MAN AND 3 WOMEN, MEAN AGE 61.6 +/- 9 YEARS, RANGE 50 ¿ 74) FROM JANUARY 2009 ¿ MAY 2010. THIS COMPLAINT IS IN REFERENCE TO PATIENT #10, IDENTIFIED AS A (B)(6) MALE WITH ATRIAL FIBRILLATION. THE TARGET LESION WAS MCA (MIDDLE CEREBRAL ARTERY) NOT OTHERWISE IDENTIFIED. UROKINASE AND TIROFIBAN WERE ADMINISTERED AND THEN A 28 MM ENTERPRISE STENT WAS USED FOR TEB PROCEDURE. POST PROCEDURE THE PATENCY OF THE TARGET VESSEL WAS ASSESSED USING MRI AND ANGIOGRAPHY. IN THIS PATIENT¿S CASE, THERE WAS NOTED INTRACEREBRAL HEMORRHAGE WITHOUT PATIENT SYMPTOMS. THE PATIENT¿S NIHSS SCORE WAS 11 AT INDEX AND 6 AT FOLLOW UP. THE DEVICE IS UNAVAILABLE FOR ANALYSIS. NO STERILE LOT NUMBER INFORMATION WAS PROVIDED, THUS NO DHR COULD BE PERFORMED. THIS IS AN OFF-LABEL USE THE ENTERPRISE DEVICE AND AS SUCH COMPLICATIONS OF THIS APPLICATION ARE NOT ADDRESSED IN THE IFU. 100% INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, TARGET LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT THE PATIENT HAD ASYMPTOMATIC INTRACRANIAL HEMORRHAGE AFTER TEB USAGE OF AN UNKNOWN ENTERPRISE STENT (ENF452812 / UNK). LITERATURE ARTICLE REVIEW: RECANALIZATION OF ACUTE INTRACRANIAL ARTERY OCCLUSION USING TEMPORARY ENDOVASCULAR BYPASS TECHNIQUE, AUTHORED BY SANG HYUN SUH, MD., KYUNG-YUL, LEE, MD., KWON DUK SEO, MD., SOO MEE LIM, MD ., HONG GEE ROH, MD., BYUNG MOON KIM, MD. PURPOSE: THE PURPOSE OF THIS STUDY IS TO PRESENT OUR PRELIMINARY EXPERIENCE OF THE TEMPORARY ENDOVASCULAR BYPASS (TEB) TECHNIQUE USING AN ENTERPRISE STENT FOR RECANALIZATION OF ACUTE INTRACRANIAL ARTERY (IA) OCCLUSION. CONCLUSION: TEB MAY BE A VALUABLE TREATMENT OPTION IN ACUTE THROMBOEMBOLIC IA OCCLUSION WITHOUT STENT IMPLANTATION. ELEVEN PATIENTS WERE ENROLLED IN THIS STUDY (8MAN AND 3 WOMEN, MEAN AGE 61.6 +/- 9 YEARS, RANGE 50 ¿ 74) FROM (B)(6) 2009 ¿ (B)(6) 2010. THIS COMPLAINT IS IN REFERENCE TO PATIENT #10, IDENTIFIED AS A (B)(6) MALE WITH ATRIAL FIBRILLATION. THE TARGET LESION WAS MCA (MIDDLE CEREBRAL ARTERY) NOT OTHERWISE IDENTIFIED. UROKINASE AND TIROFIBAN WERE ADMINISTERED AND THEN A 28 MM ENTERPRISE STENT WAS USED FOR TEB PROCEDURE. POST PROCEDURE THE PATENCY OF THE TARGET VESSEL WAS ASSESSED USING MRI AND ANGIOGRAPHY. IN THIS PATIENT¿S CASE, THERE WAS NOTED INTRACEREBRAL HEMORRHAGE WITHOUT PATIENT SYMPTOMS. THE PATIENT¿S NIHSS SCORE WAS 11 AT INDEX AND 6 AT FOLLOW UP. THE DEVICE IS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596433 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other