BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5774744 · Received July 7, 2016

    Report

    Report Number
    1226348-2016-00116
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    November 20, 2015
    Report Date
    June 16, 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

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS LITERATURE COMPLAINT. UDI: UNKNOWN PART NUMBER, LOT NUMBER; ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL , UDI UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS: SOLITAIRE AB NEUROVASCULAR REMODELING DEVICE [EV3, INC.]) WAS USED IN SOME PATIENT ALONG WITH ENTERPRISE STENT, THE NUMBER OF PATIENT THAT WERE IMPLANTED WITH BOTH ENTERPRISE AND SOLITAIRE STENTS UNKNOWN. LOT NUMBER UNKNOWN, EXPIRATION DATE AND MANUFACTURING DATE NOT AVAILABLE. THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED/KNOWN. THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE STENT DEVICE AND IS LISTED IN THE IFU. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT MEDICATION ISSUES AND PATIENT CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INSUFFICIENT PLATELET INHIBITION AND THROMBOEMBOLIC COMPLICATIONS IN PATIENTS WITH INTRACRANIAL ANEURYSMS AFTER STENT PLACEMENT¿, BY YANG, HONGCHAO, MD , YOUXIANG LI, MD , PHD, AND YUHUA JIANG, MD, PUBLISHED J NEUROSURG NOVEMBER 20, 2015, DOI: 10.3171/2015.6.JNS1511. IT WAS REPORTED THAT 75 ENTERPRISE STENTS WERE ASSOCIATED WITH THROMBOEMBOLIC COMPLICATIONS. PER THE ARTICLE: ¿INSUFFICIENT PLATELET INHIBITION HAS BEEN ASSOCIATED WITH AN INCREASED INCIDENCE OF THROMBOEMBOLIC COMPLICATIONS IN CARDIOLOGY PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. DATA REGARDING THE RELATIONSHIP BETWEEN INSUFFICIENT PLATELET INHIBITION AND THROMBOEMBOLIC COMPLICATIONS IN PATIENTS UNDERGOING NEUROVASCULAR PROCEDURES REMAIN CONTROVERSIAL. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE RELATIONSHIP OF INSUFFICIENT PLATELET INHIBITION AND THROMBOEMBOLIC COMPLICATIONS IN PATIENTS WITH INTRACRANIAL ANEURYSM UNDERGOING STENT TREATMENT¿..ONE HUNDRED SIXTY-EIGHT PATIENTS WITH 193 ANEURYSMS WERE ENROLLED IN THIS STUDY. NINETY-ONE OF 168 (54.2%) PATIENTS WITH ACUTE CEREBRAL ISCHEMIC LESIONS WERE IDENTIFIED BY DIFFUSION-WEIGHTED MRI. IN 9 (5.4%) PATIENTS WITH ISCHEMIC LESIONS, TRANSIENT ISCHEMIC ATTACK OR STROKE WAS FOUND AT DISCHARGE, AND THESE COMPLICATIONS WERE FOUND IN 11 (6.5%) PATIENTS DURING THE FOLLOW-UP PERIOD. THE INCIDENCE OF PERIPROCEDURAL THROMBOEMBOLIC COMPLICATIONS INCREASED WITH RESISTANCE TO ANTIPLATELET AGENTS, HYPERTENSION, HYPERLIPIDEMIA, COMPLETE OCCLUSION, AND ANEURYSM OF THE ANTERIOR CIRCULATION. THE MULTIVARIATE REGRESSION ANALYSIS DEMONSTRATED THAT THE ANTERIOR CIRCULATION AND ADENOSINE DIPHOSPHATE (ADP) INHIBITION PERCENTAGE WERE INDEPENDENT RISK FACTORS OF PERIOPERATIVE THROMBOEMBOLIC COMPLICATIONS. THE MAXIMUM AMPLITUDE AND ADP INHIBITION PERCENTAGE WERE INDEPENDENT RISK FACTORS FOR THROMBOEMBOLIC COMPLICATIONS DURING THE FOLLOW-UP PERIOD¿..THE ADP INHIBITION PERCENTAGE IS RELATED TO THROMBOEMBOLIC COMPLICATIONS AFTER STENT PLACEMENT FOR INTRACRANIAL ANEURYSMS. THE INCREASE OF THE ADP INHIBITION MAY DECREASE THE RISK OF THROMBOEMBOLIC COMPLICATIONS. IN THE COHORT OF PATIENTS WITH THROMBOEMBOLIC ISCHEMIC LESIONS, 75 HAD ENTERPRISE STENTS IMPLANTED. THERE WAS NO SPECIFIC TREATMENT REPORTED FOR THESE EVENTS BEYOND ADJUSTMENT OF MEDICATION REGIMEN. IT WAS NOT POSSIBLE TO RELATE THE SPECIFIC PATIENTS IDENTIFIED IN THE ARTICLE WITH THE BRAND OF STENT IMPLANTED. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429493 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention