BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7120754 · Received December 15, 2017

    Report

    Report Number
    1226348-2017-00507
    Event Type
    Death
    Date Received
    December 15, 2017
    Date of Event
    July 1, 2016
    Report Date
    November 22, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT AGE, WEIGHT AND GENDER, AS WELL AS SPECIFIC PRODUCT OR PROCEDURE INFORMATION WERE NOT PROVIDED AND COULD NOT BE OBTAINED FROM THE AUTHOR. THEREFORE, ALL THREE STENTS ASSOCIATED WITH THIS COMPLAINT ARE REPORTED IN THIS MDR REPORT. ARTICLE ATTACHED TO MDR: DERELLE A.L., BARBIER, C., TONNELET, R., LIAO, ET. AL, (2016). THREE CASES OF RUPTURED BASILAR ARTERY DISSECTION: FROM DIAGNOSIS TO ENDOVASCULAR TREATMENT, WORLD NEUROSURGERY. 91 (PP 676.E1-676.E7), 2016. DATE OF PUBLICATION: 01 JUL 2016, HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.107 CONCOMITANT DEVICES: 2 ENTERPRISE STENTS, RAPID-TRANSIT MICROCATHETER, J-SHAPED TRAXCESS 14 MICROWIRE. DATE OF EVENT, DATE OF DEATH, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. DATE OF EVENT AND DEATH LISTING ON MDR ARE THE DATE OF ARTICLE PUBLICATION. (B)(4). CONCLUSION: THE PRODUCTS WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS NOT AVAILABLE; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. ENTERPRISE STENTS ARE INDICATED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS ARISING FROM A PARENT VESSEL. HOWEVER, THE INSTRUCTIONS FOR USE (IFU) CAUTIONS ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED¿. DISSECTION IS A KNOWN POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR WITH THE PROCEDURE. THE ROOT CAUSE OF THE EXTENSION OF THE DISSECTION CANNOT BE CONCLUSIVELY DETERMINE; HOWEVER, THE PATIENT HAD PRESENTED WITH A DISSECTION; THEREFORE, THE PRE-EXISTING CONDITION AND THE OFF-LABEL USE OF THE STENTS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEWS OF COMPLAINT HISTORY 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE LITERATURE PUBLICATION AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2017-00507, 1226348-2017-00508, & 1226348-2017-00509. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE ARTICLE, A (B)(6)-YEAR-OLD MAN WAS ADMITTED IN A COMA BECAUSE OF SEVERE SUBARACHNOID HEMORRHAGE. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED AN ELONGATED IRREGULARITY IN THE UPPER HALF OF THE BASILAR ARTERY, SUGGESTING A RUPTURED DISSECTION. THE DIAGNOSIS WAS CONFIRMED BY A DIAGNOSTIC ANGIOGRAPHY, WHICH FOUND A NARROWING AND DOUBLE LUMEN ASPECT INVOLVING A LONG SEGMENT OF THE UPPER BASILAR ARTERY. ENDOVASCULAR TREATMENT WAS PERFORMED. THE DISSECTION WAS CROSSED WITH A RAPIDTRANSIT MICROCATHETER AND A TRAXCESS J-SHAPED MICROWIRE. THREE OVERLAPPING STENTS ENTERPRISE STENTS (4.5 X 22, 4.5 X 28, AND 4.5 X14MM) WERE PLACED IN THE UPPER HALF OF THE BASILAR ARTERY. THE PATIENT WAS ADMINISTERED 250 MG OF ASPIRIN DURING THE PROCEDURE, A HALF BOLUS OF ABCIXIMAB (5.65 ML) AFTER STENTING, AND A HALF LOADING DOSE OF CLOPIDOGREL (300 MG) VIA THE NASOGASTRIC TUBE AFTER THE ANGIOGRAPHY. A CTA PERFORMED 2 WEEKS LATER SHOWED A NEW DILATION OF THE LATERAL WALL OF THE BASILAR ARTERY, AND THE PATIENT DIED A FEW DAYS LATER AFTER RE-BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900075 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death