BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6416748 · Received March 20, 2017

    Report

    Report Number
    1226348-2017-00032
    Event Type
    Death
    Date Received
    March 20, 2017
    Date of Event
    December 24, 2014
    Report Date
    February 23, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LITERATURE ARTICLE IS ATTACHED TO THIS MDR REPORT: MU, S., LI C., YANG, X. ET AL. (2016). RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES. CLIN NEURORADIOL. (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. SINCE THE LOT NUMBER WAS NOT PROVIDED, DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL; HOWEVER, IT IS ANTICIPATED THAT ADDITIONAL INFORMATION MAY BE AVAILABLE. WHEN ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION COULD BE OBTAINED FOR THIS LITERATURE COMPLAINT. CONCLUSION: IN THE LITERATURE ARTICLE ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES¿ BY S. MU, C. LI, X. YANG, Y. WANG, Y. LI, C. JIANG, AND Z. WU, PUBLISHED CLIN NEURORADIOL (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4, IT WAS REPORTED THAT POST IMPLANTATION OF AN UNKNOWN ENTERPRISE STENT AND A SOLITAIRE STENT, THE PATIENT EXPIRED DUE TO SUBARACHNOID HEMORRHAGE. THE PATIENT HAD PRESENTED WITH MASS EFFECT ON THE BRAIN STEM WITH MRS 2. ANGIOGRAPHY REVEALED A DOLICHOECTATIC, LOWER BASILAR ARTERY ANEURYSM. AFTER THE STENT ASSISTED COIL EMBOLIZATION THE ANEURYSM WAS PARTIALLY OCCLUDED. THE PATIENT EXPERIENCED SUDDEN UNCONSCIOUSNESS, TACHYCARDIA, AND BREATH ARREST THREE HOURS AFTER THE PROCEDURE. HIS CONDITION DETERIORATED SO RAPIDLY THAT HE EXPIRED 17 HOURS AFTER EMBOLIZATION. THE EXACT REASON THE PATIENT EXPIRED WAS UNCERTAIN BECAUSE OF THE ABSENCE OF RADIOLOGIC RESULTS AFTER THE STENT ASSISTED COIL EMBOLIZATION. THE PRESUMPTION IS THAT THE BRAINSTEM MASS EFFECT WAS AGGRAVATED, OR IN-STENT THROMBOSIS OR SUBARACHNOID HEMORRHAGE OCCURRED. NO ADDITIONAL PATIENT, DEVICE OR PROCEDURE INFORMATION WAS PROVIDED. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) FOLLOWING RECONSTRUCTIVE ENDOVASCULAR TREATMENT (EVT) WITH STENT(S). THEY RETROSPECTIVELY IDENTIFIED 21 PATIENTS WITH SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VBDAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE EVT BETWEEN SEPTEMBER 2009 AND SEPTEMBER 2013 AT ONE FACILITY. THERE WERE 20 MEN AND 1 WOMAN, WITH A MEAN AGE OF 46.5 YEARS (RANGE: 17¿67 YEARS). TEN PATIENTS HAD SOLE STENTING AND 11 PATIENTS HAD STENT-ASSISTED COILING WITH USE OF EITHER ENTERPRISE, SOLITAIRE OR NEUROFORM STENT(S). IN 14 CASES, THE POST-PROCEDURAL PROCESSES WERE UNEVENTFUL AND NO COMPLICATION WAS OBSERVED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. STROKE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE ENTERPRISE STENT AND THE STENTING PROCEDURE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE HEMORRHAGE; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT (PATIENT PRESENTED WITH NEUROLOGICAL DEFICIT). ANTIPLATELET MEDICATIONS MAY HAVE CONTRIBUTED TO THE HEMORRHAGE. IN ADDITION, THE IFU CAUTIONS: ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED. THERE IS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES¿ BY S. MU, C. LI, X. YANG, Y. WANG, Y. LI, C. JIANG, AND Z. WU, PUBLISHED CLIN NEURORADIOL (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4, IT WAS REPORTED THAT POST IMPLANTATION OF AN UNKNOWN ENTERPRISE STENT AND A SOLITAIRE STENT, THE PATIENT EXPIRED DUE TO SUBARACHNOID HEMORRHAGE. THE PATIENT HAD PRESENTED WITH MASS EFFECT ON THE BRAIN STEM WITH MRS 2. ANGIOGRAPHY REVEALED A DOLICHOECTATIC, LOWER BASILAR ARTERY ANEURYSM. AFTER THE STENT ASSISTED COIL EMBOLIZATION, THE ANEURYSM WAS PARTIALLY OCCLUDED. THE PATIENT EXPERIENCED SUDDEN UNCONSCIOUSNESS, TACHYCARDIA, AND BREATH ARREST THREE HOURS AFTER THE PROCEDURE. HIS CONDITION DETERIORATED SO RAPIDLY THAT HE EXPIRED 17 HOURS AFTER EMBOLIZATION. THE EXACT REASON THE PATIENT EXPIRED WAS UNCERTAIN BECAUSE OF THE ABSENCE OF RADIOLOGIC RESULTS AFTER THE STENT ASSISTED COIL EMBOLIZATION. THE PRESUMPTION IS THAT THE BRAINSTEM MASS EFFECT WAS AGGRAVATED, OR IN-STENT THROMBOSIS OR SUBARACHNOID HEMORRHAGE OCCURRED. NO ADDITIONAL PATIENT, DEVICE OR PROCEDURE INFORMATION WAS PROVIDED. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) FOLLOWING RECONSTRUCTIVE ENDOVASCULAR TREATMENT (EVT) WITH STENT(S). THEY RETROSPECTIVELY IDENTIFIED 21 PATIENTS WITH SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VBDAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE EVT BETWEEN SEPTEMBER 2009 AND SEPTEMBER 2013 AT ONE FACILITY. THERE WERE 20 MEN AND 1 WOMAN, WITH A MEAN AGE OF 46.5 YEARS (RANGE: 17¿67 YEARS). TEN PATIENTS HAD SOLE STENTING AND 11 PATIENTS HAD STENT-ASSISTED COILING WITH USE OF EITHER ENTERPRISE, SOLITAIRE OR NEUROFORM STENT(S). IN 14 CASES, THE POST-PROCEDURAL PROCESSES WERE UNEVENTFUL AND NO COMPLICATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201493 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death