BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 7022943 · Received November 10, 2017

    Report

    Report Number
    1226348-2017-00185
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    March 1, 2017
    Report Date
    October 21, 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

    WANG X., WANG Z., JI Y., ET AL. (2017). ENTERPRISE STENT IN RECANALIZING NON-ACUTE ATHEROSCLEROTIC INTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION. CLINICAL NEUROLOGY AND NEUROSURGERY, 162 (PP 47-52), 2017. DATE OF PUBLICATION: NOVEMBER 2017, HTTP://DX.DOI.ORG/10.1016/J.CLINEURO.2017.06.015). DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, NO LOT NUMBERS COULD BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICES. DEPLOYMENT DIFFICULTY, STENT OR VESSEL THROMBOSIS, VASOSPASM AND STROKE ARE ALL POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE OR THE PROCEDURE AND ARE LISTED IN THE INSTRUCTIONS FOR USE AS SUCH. PATIENTS WERE AT RISK FOR STROKE BASED ON HISTORY OF HYPERTENSION. THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED; HOWEVER, THE IFU CAUTIONS ¿THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM¿. THE IFU FURTHER STATED THAT THE DEVICE IS ¿INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS¿. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEWS OF COMPLAINT HISTORIES FOR THE DEVICES. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE (WANG X.; WANG Z.; JI Y.; DING X.; ZANG Y.; WANG C., ¿ENTERPRISE STENT IN RECANALIZING NON-ACUTE ATHEROSCLEROTIC INTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION¿ PUBLISHED BY CLINICAL NEUROLOGY AND NEUROSURGERY. 162 (PP 47-52), 2017. DATE OF PUBLICATION: NOVEMBER 2017, HTTP://DX.DOI.ORG/10.1016/J.CLINEURO.2017.06.015), IT WAS REPORTED THAT THERE WERE EVENTS OF DEPLOYMENT DIFFICULTY, ACUTE THROMBOSIS, AND CAROTID SPASM DURING TREATMENT WITH AN ENTERPRISE STENT, AND 5 MONTHS AFTER THE PROCEDURE, A PATIENT EXPERIENCED A STROKE. IT WAS NOT POSSIBLE TO IDENTIFY SPECIFIC DEVICE, PATIENT OR PROCEDURE INFORMATION FOR THE PATIENTS. ALL PATIENTS HAD THE HISTORY OF HYPERTENSION. IN ADDITION, 5 PATIENTS HAD TYPE 2 DIABETES MELLITUS, AND 8 PATIENTS HAD HYPERLIPIDEMIA. A TOTAL OF 12 ENTERPRISE STENTS WERE IMPLANTED, INCLUDING TWO 4.5 MM× 14 MM STENTS AND TEN 4.5 MM×22 MM STENTS. THE STUDY PRESENTED IN THE ARTICLE WAS PERFORMED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF RECANALIZATION IN NON-ACUTE OCCLUSION OF INTRACRANIAL INTERNAL CAROTID ARTERIES USING THE FLEXIBLE ENTERPRISE SELF-EXPANDING STENT. FROM JUNE 2014 TO JUNE 2016, 12 CONSECUTIVE PATIENTS WITH NON-ACUTE OCCLUSION OF INTRACRANIAL INTERNAL CAROTID ARTERIES RECEIVED ENDOVASCULAR RECANALIZATION WITH ENTERPRISE STENTING. ALL PATIENTS RECEIVED MEDICATION FOR ANTI-PLATELET AGGREGATION THERAPY BEFORE AND AFTER THE OPERATION. ENDOVASCULAR RECANALIZATION WAS SUCCESSFULLY PERFORMED IN 10 OUT OF 12 PATIENTS WITH ENTERPRISE STENTING. STENT IMPLANTATION FOLLOWING BALLOON DILATATION FAILED IN ONE PATIENT BECAUSE THE LUMEN DIAMETER WAS TOO SMALL. ANOTHER RECANALIZATION FAILED BECAUSE THE UNSPECIFIED GUIDE WIRE COULD NOT PASS THROUGH THE OCCLUSION. ONE PATIENT DEVELOPED IN-STENT THROMBOSIS, BUT THIS WAS RESOLVED AFTER THROMBOLYTIC THERAPY VIA MICROCATHETER DELIVERY OF 400,000 U UROKINASE AND 500 UG OF TIROFIBAN. ANOTHER PATIENT DEVELOPED INTRAOPERATIVE ARTERY SPASM, BUT THIS WAS RELIEVED AFTER TOPICAL NIMOTOP AND PAPAVERINE APPLICATION. NO PERIOPERATIVE MORTALITY WAS OBSERVED. ONE STROKE EVENT OCCURRED IN THE 10 PATIENTS WHO COMPLETED THE FOLLOW-UP. THE ARTICLE CONCLUDED THAT THE ENTERPRISE STENT WAS SHOWN TO BE SAFE AND EFFICIENT IN RECANALIZING NON-ACUTE ATHEROSCLEROTIC INTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION. HOWEVER, THE LONG-TERM OUTCOMES NEED TO BE FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799946 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening