BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5497551 · Received March 14, 2016

    Report

    Report Number
    1058196-2016-00051
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    October 8, 2015
    Report Date
    February 19, 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

    UDI: THE PRODUCT AND LOT NUMBERS WERE NOT AVAILABLE; THEREFORE, THE UDI IS UNKNOWN. LITERATURE ARTICLE ATTACHED TO THIS MDR: FENG, Z., DUAN, D., ZHANG, P. ET AL, (2015) ¿ENTERPRISE STENT FOR THE TREATMENT OF SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS: AN INITIAL EXPERIENCE OF 44 PATIENTS¿ BMC NEUROLOGY.15:187, DOI 10.1186/S12883-015-0443-9). CONCOMITANT MEDICAL PRODUCTS: A STRYKER BALLOON CATHETER, PROWLER SELECT PLUS MICROCATHETER WERE USED DURING THE PROCEDURE. A DOSE OF 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS GIVEN AT LEAST 3 DAYS BEFORE THE PROCEDURE, AND DURING INTERVENTION, PATIENTS WERE HEPARINIZED TO A DOUBLED ACTIVATED CLOTTING TIME. A DAILY DOSE OF 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS RECOMMENDED FOR 6 WEEKS AFTER DISCHARGE, FOLLOWED BY ASPIRIN ONLY. THIS IS 1 OF 7 MDR REPORTS BEING SUBMITTED FOR THIS LITERATURE REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION COULD BE OBTAINED.CONCLUSION:AS REPORTED IN A LITERATURE ARTICLE (FENG, Z., DUAN, D., ZHANG, P. ET AL, (2015) ¿ENTERPRISE STENT FOR THE TREATMENT OF SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS: AN INITIAL EXPERIENCE OF 44 PATIENTS¿ BMC NEUROLOGY.15:187, DOI 10.1186/S12883-015-0443-9), FOUR PATIENTS EXPERIENCED A NEW EMERGING ISCHEMIC STROKE THAT WAS CLASSIFIED AS A PERFORATOR EVENT, AND THREE PATIENTS DEVELOPED IN-STENT RESTENOSIS. THE RETROSPECTIVE STUDY ASSESSED THE SAFETY AND EFFICACY OF UNDERSIZED BALLOON ANGIOPLASTY FOLLOWED BY DEPLOYMENT OF AN ENTERPRISE STENT FOR THE TREATMENT OF COMPLEX SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS. FORTY-FOUR PATIENTS ON COMBINED ANTIPLATELET THERAPY AND INTENSIVE RISK FACTOR MANAGEMENT, WITH A SYMPTOMATIC 70- 99% STENOSIS OF A MAJOR INTRACRANIAL ARTERY IN COMPLEX SETTINGS WERE ENROLLED BETWEEN JULY 2009 AND AUGUST 2013. OVERALL PROCEDURAL SUCCESS RATE WAS 100%. THERE WERE 32 MEN AND 12 WOMEN ENROLLED, WITH A MEAN AGE OF 60. ALL PATIENTS PRESENTED WITH AN ISCHEMIC STROKE (26 PATIENTS) OR A TIA (18 PATIENTS). A DOSE 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS GIVEN AT LEAST 3 DAYS BEFORE THE PROCEDURE, AND DURING INTERVENTION, PATIENTS WERE HEPARINIZED TO A DOUBLED ACTIVATED CLOTTING TIME. A DAILY DOSE OF 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS RECOMMENDED FOR 6 WEEKS AFTER DISCHARGE, FOLLOWED BY ASPIRIN ONLY. THE THIRD PATIENT WITH A INSTENT RESTENOSIS AT FOLLOW-UP VISIT (IDENTIFIED AS (B)(6)) HAD A 90% STENOTIC, 9.75MM LONG BASILAR ARTERY LESION TREATED WITH PRE-DILATION WITH A 2.5 X 15MM NON-CODMAN BALLOON CATHETER AT 5.0 ATM FOLLOWED BY IMPLANTATION OF A SINGLE 4.5 X 15MM ENTERPRISE STENT. POST-PROCEDURE STENOSIS WAS 30%. AT 7 MONTHS POST-PROCEDURE, THE PATIENT WAS NOTED TO HAVE 70% INSTENT RESTENOSIS, WITH NO SYMPTOMS. NO RE-TREATMENT WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED, INCLUDING PATIENT DEMOGRAPHICS OR CATALOG/LOT NUMBERS OF THE ENTERPRISE DEVICE. NO ADDITIONAL INFORMATION COULD BE OBTAINED.THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED.THE EVENT THAT OCCURRED DURING THE OFF-LABEL USE OF THE ENTERPRISE STENT COULD NOT BE CONFIRMED WITHOUT PROCEDURE FILMS OR ADDITIONAL INFORMATION; HOWEVER, STENOSIS IS KNOWN POTENTIAL EVENT ASSOCIATED WITH THE ENTERPRISE STENT. THERE IS A KNOWN RISK OF STENOSIS OF STENT IMPLANTS IN GENERAL. THE INSTRUCTIONS FOR USE (IFU) WARNS ¿STENOSIS MAY REQUIRE DILATATION OF THE VESSEL SEGMENT CONTAINING THE STENT. THE RISKS AND LONG-TERM OUTCOME FOLLOWING DILATATION OF ENDOTHELIALIZED STENTS IS UNKNOWN AT PRESENT. THE ABILITY OF THE STENT TO WITHSTAND POST BALLOON DILATION HAS NOT BEEN ESTABLISHED.¿ THE ENTERPRISE SENT IS NOT INTENDED FOR USE FOR TREATMENT OF VESSEL STENOSIS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTM IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSM ARISING FROM A PARENT VESSEL¿. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.THIS IS 1 OF 7 MDR REPORTS BEING SUBMITTED FOR THIS LITERATURE COMPLAINT.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE, FOUR PATIENTS EXPERIENCED A NEW EMERGING ISCHEMIC STROKE THAT WAS CLASSIFIED AS A PERFORATOR EVENT, AND THREE PATIENTS DEVELOPED IN-STENT RESTENOSIS. THE RETROSPECTIVE STUDY ASSESSED THE SAFETY AND EFFICACY OF UNDERSIZED BALLOON ANGIOPLASTY FOLLOWED BY DEPLOYMENT OF AN ENTERPRISE STENT FOR THE TREATMENT OF COMPLEX SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS. FORTY-FOUR PATIENTS ON COMBINED ANTIPLATELET THERAPY AND INTENSIVE RISK FACTOR MANAGEMENT, WITH A SYMPTOMATIC 70- 99% STENOSIS OF A MAJOR INTRACRANIAL ARTERY IN COMPLEX SETTINGS WERE ENROLLED BETWEEN JULY 2009 AND AUGUST 2013. OVERALL PROCEDURAL SUCCESS RATE WAS 100%. THERE WERE 32 MEN AND 12 WOMEN ENROLLED, WITH A MEAN AGE OF 60. ALL PATIENTS PRESENTED WITH AN ISCHEMIC STROKE (26 PATIENTS) OR A TIA (18 PATIENTS). A DOSE 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS GIVEN AT LEAST 3 DAYS BEFORE THE PROCEDURE, AND DURING INTERVENTION, PATIENTS WERE HEPARINIZED TO A DOUBLED ACTIVATED CLOTTING TIME. A DAILY DOSE OF 300MG ASPIRIN AND 75MG CLOPIDOGREL WAS RECOMMENDED FOR 6 WEEKS AFTER DISCHARGE, FOLLOWED BY ASPIRIN ONLY. THE THIRD PATIENT WITH A INSTENT RESTENOSIS AT FOLLOW-UP VISIT (IDENTIFIED AS CASE 3 ON TABLE 4) HAD A 90% STENOTIC, 9.75MM LONG BASILAR ARTERY LESION TREATED WITH PRE-DILATION WITH A 2.5 X 15MM NON-CODMAN BALLOON CATHETER AT 5.0 ATM FOLLOWED BY IMPLANTATION OF A SINGLE 4.5 X 15MM ENTERPRISE STENT. POST-PROCEDURE STENOSIS WAS 30%. AT 7 MONTHS POST-PROCEDURE, THE PATIENT WAS NOTED TO HAVE 70% INSTENT RESTENOSIS, WITH NO SYMPTOMS. NO RE-TREATMENT WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED, INCLUDING PATIENT DEMOGRAPHICS OR CATALOG/LOT NUMBERS OF THE ENTERPRISE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153389 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R