BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6095413 · Received November 11, 2016

    Report

    Report Number
    1226348-2016-00165
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    November 26, 2015
    Report Date
    October 19, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: ASPIRIN 325MG/DAY AND THIENOPYRIDINE DERIVATIVE 7 DAYS PRIOR TO THE INDEX PROCEDURE, CLOPIDOGREL 75 MG/DAY AND ASPIRIN 75 TO 325 MG/DAY POST PROCEDURE. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, INCLUDING THE DATE OF THE PROCEDURE AND DEVICE CATALOG NUMBER, LOT NUMBER, MANUFACTURE DATE AND EXPIRATION DATES WERE UNSUCCESSFUL. LITERATURE ARTICLE ATTACHED TO THIS MDR REPORT: BRASILIENSE L.B, YOON J.W., ORINA J.N., ET AL. (01 FEB 2016). A REAPPRAISAL OF ANTERIOR COMMUNICATING ARTERY ANEURYSMS: A CASE FOR STENT-ASSISTED EMBOLIZATION, NEUROSURGERY. 78 (2) (PP 200-207), 2016. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE AS REPORTED VIA THE LITERATURE ARTICLE A REAPPRAISAL OF ANTERIOR COMMUNICATING ARTERY ANEURYSMS: A CASE FOR STENT-ASSISTED EMBOLIZATION BY : BRASILIENSE L.B.C.; YOON J.W.; ORINA J.N., ET AL, THE 4.5 X 22MM ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) COULD NOT CONTAIN THE COILS INSIDE THE ANEURYSM FOR PATIENT # 16. THE STENT WAS DEPLOYED FROM THE RIGHT A1 TO THE IPSILATERAL A2, PROVIDING NEAR COMPLETE COVERAGE OF THE ANEURYSM NECK; HOWEVER, DESPITE SUCCESSFUL STENT DEPLOYMENT, THE COILS COULD NOT BE SAFELY CONTAINED INSIDE THE ANEURYSM. AT EVERY ATTEMPT TO DEPLOY, THE COIL MASS WOULD REPEATEDLY PROTRUDE AND MOVE TOWARDS THE CONTRALATERAL A2, THUS PROMPTING THE PROCEDURE TO BE ABORTED. THIS WAS INCLUDED AS A STUDY TECHNICAL COMPLICATION. THE PURPOSE OF THE STUDY DESCRIBED IN THE ARTICLE WAS TO ASSESS THE LONG-TERM CLINICAL AND ANGIOGRAPHIC OUTCOMES OF STENT-ASSISTED EMBOLIZATION FOR WIDE-NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSMS. BETWEEN MARCH 2008 AND MARCH 2014, 32 PATIENTS WITH UNRUPTURED WIDE NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSMS WERE TREATED USING STENT-ASSISTED EMBOLIZATION. THE MEAN ANEURYSM SIZE WAS 7.3MM (RANGE, 3.2-23.0 MM) AND ALL LESIONS HAD A WIDE-NECK (DOME-TO-NECK RATIO.2) AND WERE CONSIDERED UNFAVORABLE FOR PRIMARY COILING. IN ALL CASES, ONLY 1 STENT WAS USED. THERE WERE NO PERI-PROCEDURAL THROMBOEMBOLIC OR HEMORRHAGIC COMPLICATIONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. COIL MIGRATION/PROLAPSE INTO NORMAL VESSELS ADJACENT TO THE ANEURYSM IS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR WITH THE PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT; HOWEVER, ANEURYSM/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THE ARTICLE INDICATED THAT NEAR COMPLETE COVERAGE OF THE ANEURYSM NECK. THE IFU STATES TO SELECT A STENT LENGTH THAT IS AT LEAST 10MM LINGER THEN THE ANEURYSM NECK TO INSURE A MINIMUM OF 5MM ON EITHER SIDE OF THE ANEURYSM NECK. 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 VIA THE LITERATURE ARTICLE A REAPPRAISAL OF ANTERIOR COMMUNICATING ARTERY ANEURYSMS: A CASE FOR STENT-ASSISTED EMBOLIZATION BY : BRASILIENSE L.B.C.; YOON J.W.; ORINA J.N.; MILLER D.A.; TAWK R.G.; HANEL R.A . NEUROSURGERY. 78 (2) (PP 200-207), 2016. DATE OF PUBLICATION: 01 FEB 2016, THE 4.5 X 22MM ENTERPRISE STENT (CATALOG AND LOT UNKNOWN) COULD NOT CONTAIN THE COILS INSIDE THE ANEURYSM FOR PATIENT # 16. THE STENT WAS DEPLOYED FROM THE RIGHT A1 TO THE IPSILATERAL A2, PROVIDING NEAR COMPLETE COVERAGE OF THE ANEURYSM NECK; HOWEVER, DESPITE SUCCESSFUL STENT DEPLOYMENT, THE COILS COULD NOT BE SAFELY CONTAINED INSIDE THE ANEURYSM. AT EVERY ATTEMPT TO DEPLOY, THE COIL MASS WOULD REPEATEDLY PROTRUDE AND MOVE TOWARDS THE CONTRALATERAL A2, THUS PROMPTING THE PROCEDURE TO BE ABORTED. THIS WAS INCLUDED AS A STUDY TECHNICAL COMPLICATION. THE PURPOSE OF THE STUDY DESCRIBED IN THE ARTICLE WAS TO ASSESS THE LONG-TERM CLINICAL AND ANGIOGRAPHIC OUTCOMES OF STENT-ASSISTED EMBOLIZATION FOR WIDE-NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSMS. BETWEEN MARCH 2008 AND MARCH 2014, 32 PATIENTS WITH UNRUPTURED WIDE NECKED ANTERIOR COMMUNICATING ARTERY ANEURYSMS WERE TREATED USING STENT-ASSISTED EMBOLIZATION. THE MEAN ANEURYSM SIZE WAS 7.3MM (RANGE, 3.2-23.0 MM) AND ALL LESIONS HAD A WIDE-NECK (DOME-TO-NECK RATIO.2) AND WERE CONSIDERED UNFAVORABLE FOR PRIMARY COILING. IN ALL CASES, ONLY 1 STENT WAS USED. THERE WERE NO PERI-PROCEDURAL THROMBOEMBOLIC OR HEMORRHAGIC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747333 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention