BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5906987 · Received August 26, 2016

    Report

    Report Number
    1226348-2016-00131
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    March 9, 2016
    Report Date
    August 17, 2016
    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

    NO ADDITIONAL INFORMATION COULD BE OBTAINED. IN THE CONFERENCE ABSTRACT FOUND IN A LITERATURE SEARCH ¿ENDOVASCULAR TREATMENT OF DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS¿ BY JUN TANG, MD, LINJIE WEI, MD, LIN LI, MD, YIN NIU, MD, QIANWEI CHEN, MD, HUA FENG, MD, PHD, GANG ZHU, MD, PHD, ZHI CHEN, MD, PHD., PUBLISHED NEUROSCIENCES 2016; VOL. 21 (3): 236-240, DOI: 10.17712/NSJ.2016.3.20160076., IT WAS REPORTED AN ANEURYSM RUPTURED INTRAOPERATIVELY IN A PATIENT BEING TREATED WITH STENT ASSISTED COILING USING AND ENTERPRISE STENT (CATALOG/LOT NOT REPORTED). THE AUTHOR¿S ASSESS THE FEASIBILITY AND RESULTS OF ENDOVASCULAR TREATMENT FOR RUPTURED DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSMS. THEY RETROSPECTIVELY REVIEWED RESULTS WITH ENDOVASCULAR TREATMENTS FOR A SERIES OF 13 CONSECUTIVE PATIENTS WITH RUPTURED DISTAL PICA ANEURYSMS AT THEIR FACILITY FROM JUNE, 2011 AND JANUARY 2015. ENDOVASCULAR EMBOLIZATION WAS PERFORMED IN ALL 13 PATIENTS INCLUDING SELECTIVE COILING (4), STENT-ASSISTED COILING (2), MICROCATHETER-ASSISTED COILING (1), COILING WITHOUT ADJUNCTIVE TECHNIQUES (1), AND PARENT ARTERY OCCLUSION (5). NO PATIENT EXPERIENCED POST PROCEDURAL HEMORRHAGE DURING THE FOLLOW-UP PERIOD (8-46 MONTHS; MEAN, 26.8 MONTHS). AS PER THE ARTICLE (TABLE 1), CASE# 5, A (B)(6) YEAR OLD FEMALE PRESENTED WITH SACCULAR ANEURYSM AT THE ANTERIOR-MEDULLARY SEGMENT OF THE DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY EXPERIENCED AN INTRAOPERATIVE RUPTURE OF THE ANEURYSM. THE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION. THE COIL PACKING PROCEDURE WAS THEN CONTINUED UNTIL COMPLETE OCCLUSION WAS ACHIEVED, AND THE PATIENT RECOVERED WELL. NO POST PROCEDURAL HEMORRHAGE OR DELAYED CEREBRAL INFARCTION WAS EXPERIENCED. STABLE OCCLUSION WAS FOUND WITH NO SIGNS OF RECANALIZATION IN ALL STUDY PATIENTS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. VESSEL OR ANEURYSM RUPTURE ARE KNOWN PROCEDURAL ADVERSE EVENTS ASSOCIATED WITH THE ENTERPRISE STENT AND THE STENTING PROCEDURE. WITHOUT PROCEDURE FILMS TO REVIEW, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, PROCEDURE OR ANEURYSM FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE ATTACHED TO THIS MDR REPORT: TANG J., WEI L, LI L., ET AL (2016). ¿ENDOVASCULAR TREATMENT OF DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS¿, NEUROSCIENCES 2016; VOL. 21 (3): 236-240, DOI: 10.17712/NSJ.2016.3.20160076. UDI: THE PRODUCT NUMBER WAS NOT PROVIDED; THEREFORE, UDI IS NOT AVAILABLE. THE CATALOG NUMBER AND LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DATE OF THE EVENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT NO LONGER MEETS MDR CRITERIA. THE FOLLOWING INFORMATION WAS RECEIVED ON 10/25/2016 FROM OUR (B)(6) AFFILIATE: THE AUTHOR REVIEWED THE PATIENT¿S MEDICAL RECORD AND CONFIRMED, THAT THE ANEURYSM RUPTURE HAPPENED BEFORE THE ENTERPRISE STENT WAS IMPLANTED. SO HE CONSIDERED THIS EVENT WAS NOT CAUSED BY ENTERPRISE. THIS CASE IS NOT A REPORTABLE CASE, SO WE SUBMITTED A SUPPLEMENTARY REPORT TO CFDA, APPLYING TO WITHDRAWAL THIS REPORT.

    Description of Event or Problem · 1

    IN THE CONFERENCE ABSTRACT FOUND IN A LITERATURE, IT WAS REPORTED AN ANEURYSM RUPTURED INTRA-OPERATIVELY IN A PATIENT BEING TREATED WITH STENT ASSISTED COILING USING AN ENTERPRISE STENT (CATALOG/LOT NOT REPORTED). THE AUTHOR'S ASSESS THE FEASIBILITY AND RESULTS OF ENDOVASCULAR TREATMENT FOR RUPTURED DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSMS. THEY RETROSPECTIVELY REVIEWED RESULTS WITH ENDOVASCULAR TREATMENTS FOR A SERIES OF 13 CONSECUTIVE PATIENTS WITH RUPTURED DISTAL PICA ANEURYSMS AT THEIR FACILITY BETWEEN JUNE, 2011 AND JANUARY 2015. ENDOVASCULAR EMBOLIZATION WAS PERFORMED IN ALL 13 PATIENTS INCLUDING SELECTIVE COILING (4), STENT-ASSISTED COILING (2), MICROCATHETER-ASSISTED COILING (1), COILING WITHOUT ADJUNCTIVE TECHNIQUES (1), AND PARENT ARTERY OCCLUSION (5). NO PATIENT EXPERIENCED POST PROCEDURAL HEMORRHAGE DURING THE FOLLOW-UP PERIOD (8-46 MONTHS; MEAN, 26.8 MONTHS). AS PER THE ARTICLE (TABLE 1), PATIENT # 5, A 56 YEAR OLD FEMALE PRESENTED WITH SACCULAR ANEURYSM AT THE ANTERIOR-MEDULLARY SEGMENT OF THE DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY. AN INTRAOPERATIVE RUPTURE OF THE ANEURYSM OCCURRED. PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION. THE COIL PACKING PROCEDURE WAS THEN CONTINUED UNTIL COMPLETE OCCLUSION WAS ACHIEVED, AND THE PATIENT RECOVERED WELL. NO POST PROCEDURAL HEMORRHAGE OR DELAYED CEREBRAL INFARCTION WAS EXPERIENCED. STABLE OCCLUSION WAS FOUND WITH NO SIGNS OF RECANALIZATION IN ALL STUDY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560388 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR