BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7109000 · Received December 12, 2017

    Report

    Report Number
    1226348-2017-00502
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: LINZEY J. R., GRIAUZDE J., GUAN Z., ET AL. (2017). STENT-ASSISTED COILING OF CEREBROVASCULAR ANEURYSMS: EXPERIENCE AT A LARGE TERTIARY CARE CENTER WITH A FOCUS ON PREDICTORS OF RECURRENCE. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 9(11), 1081-1085. DOI:10.1136/NEURINTSURG-2016-012704. PATIENT-SPECIFIC INFORMATION WAS NOT PROVIDED. THE ARTICLE WAS PUBLISHED IN NOVEMBER 2017. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE IS BEING REPORTED AS (B)(6) 2017. THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE PERFORMED. BASED ON THE MINIMAL INFORMATION PROVIDED IN THE ARTICLE FOR EACH OF THESE EVENTS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSES OF THE EVENTS. HOWEVER, ANEURYSM RUPTURE COULD BE RELATED TO DAMAGE FROM COILS, MICROCATHETER OR THE STENT. VESSEL/ANEURYSM CHARACTERISTICS COULD HAVE CONTRIBUTED TO THE EVENT. IF THE PATIENT WAS BEING TREATED FOR A RUPTURED ANEURYSM, THE RISK OF RE-RUPTURED WOULD BE INCREASED. THE RISK OF INTRACRANIAL HEMORRHAGE WOULD HAVE BEEN INCREASED IF THE PATIENT HAD PRESENTED WITH STROKE SYMPTOMS, AND ADMINISTRATION OF ANTI-PLATELET MEDICATIONS WOULD INCREASE THE RISK OF HEMORRHAGE. THE RISK OF EMBOLIC EVENTS WOULD HAVE INCREASED IF THE PATIENT HAD PRE-EXISTING THROMBUS OR ATHEROSCLEROTIC PLAQUE AT THE TREATMENT AREA. RUPTURE OF VESSEL OR ANEURYSM, STROKE, AND EMBOLI ARE ALL POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR THE STENTING PROCEDURE. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS. PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEWS OF COMPLAINT HISTORIES FOR THE DEVICE. SINCE THERE IS NO EVIDENCE TO SUGGEST THE EVENTS ARE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE LITERATURE PUBLICATION AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2017-00501, 1226348-2017-00502, 1226348-2017-00503, & 1226348-2017-00504.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE PUBLICATION (LINZEY J. R., GRIAUZDE J., GUAN Z., ET AL. (2017). STENT-ASSISTED COILING OF CEREBROVASCULAR ANEURYSMS: EXPERIENCE AT A LARGE TERTIARY CARE CENTER WITH A FOCUS ON PREDICTORS OF RECURRENCE. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 9(11), 1081-1085. DOI:10.1136/NEURINTSURG-2016-012704), ONE (0.8%) OF THE 122 PATIENTS EXPERIENCED AN INTRAOPERATIVE RUPTURE, IN ANOTHER PATIENT (0.8%) THE TREATMENT WAS COMPLICATED BY AN INTRACRANIAL HEMORRHAGE, AND TWO (1.6%) PATIENTS DEVELOPED EMBOLIC EVENTS FOLLOWING STENT-ASSISTED COILING. THERE WERE THEREFORE A TOTAL OF FOUR (3.3%) PROCEDURE-RELATED COMPLICATIONS IN THE PATIENT POPULATION. TWO COMPLICATIONS OCCURRED WITH ENTERPRISE STENTS (2/30; 6.7%) AND TWO OCCURRED WITH NEUROFORM STENTS (2/92; 2.2%). NO PROCEDURE, PATIENT, OR DEVICE-SPECIFIC INFORMATION (INCLUDING CATALOG AND LOT NUMBER) WAS PROVIDED IN THE ARTICLE. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE INSTITUTIONAL EXPERIENCE WITH STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS AND TO IDENTIFY PREDICTORS OF RECURRENCE INCLUDING DIFFERENCES IN CLINICAL AND RADIOGRAPHIC OUTCOMES BETWEEN PATIENTS UNDERGOING NEUROFORM (STRYKER, (B)(4), USA) VERSUS ENTERPRISE STENT PLACEMENT. THERE WERE 97 WOMEN AND 25 MEN WITH AVERAGE AGE OF 57 WERE TREATED WITH STENT-ASSISTED COILING BETWEEN 1 JANUARY 2005 TO 10 JANUARY 2012. ALL PATIENTS UNDERGOING ELECTIVE STENT-ASSISTED COIL EMBOLIZATION WERE PRETREATED WITH DUAL ANTIPLATELET AGENTS (ASPIRIN (ASA) AND CLOPIDOGREL) FOR 1 WEEK. PATIENTS WERE HEPARINIZED BASED ON BODY WEIGHT (60-100 IU/KG) TO MAINTAIN AN ACTIVATED CLOTTING TIME BETWEEN 250 AND 300 S. IN SOME CASES, POSTOPERATIVE CARE INCLUDED HEPARIN INFUSION INTRAVENOUSLY AT 500 UNITS/HR AND OR DEXTRAN-40 INFUSION INTRAVENOUSLY AT 25 MG/HR, DEPENDING ON SURGEON PREFERENCE. PATENTS WERE MAINTAINED ON DUAL ANTI-PLATELET THERAPY FOR 3-6 MONTHS, AFTER WHICH CLOPIDOGREL WAS DISCONTINUED. ASPIRIN THERAPY WAS MAINTAINED INDEFINITELY. AN SL-10 MICROCATHETER (STRYKER NEUROVASCULAR, FREMONT, CALIFORNIA, USA) AND A SYNCHRO 14 WIRE (STRYKER NEUROVASCULAR) WERE ALSO USED FOR THE PROCEDURES. AT THE TIME OF SURGERY, ALL 122 ANEURYSMS WERE COILED TO SATISFACTORY OCCLUSION (RAYMOND-ROY CLASS I OR II). TWENTY-ONE (17.2%) OF THE 122 TREATED PATIENTS EXPERIENCED RECURRENCE AT AN AVERAGE FOLLOW-UP OF 297 DAYS; HOWEVER, THE ARTICLE DID NOT SPECIFY THE COILS USED DURING THE PROCEDURE. ELEVEN OF THE THIRTY PROCEDURES THAT USED ENTERPRISE STENTS HAD A RECURRENCE COMPARED WITH ONLY 10 OF THE 92 PROCEDURES THAT USED NEUROFORM STENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889204 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening