BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6416808 · Received March 20, 2017

    Report

    Report Number
    1226348-2017-00033
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    December 24, 2014
    Report Date
    February 23, 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

    NO ADDITIONAL INFORMATION COULD BE OBTAINED FOR THIS LITERATURE COMPLAINT. CONCLUSION: IN THE LITERATURE ARTICLE ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES¿ BY S. MU, C. LI, X. YANG, Y. WANG, Y. LI, C. JIANG, AND Z. WU, PUBLISHED CLIN NEURORADIOL (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4, IT WAS REPORTED THAT POST IMPLANTATION OF A TWO UNKNOWN ENTERPRISE STENTS DURING STENT ASSISTED COIL EMBOLIZATION, THE PATIENT (CASE (B)(4)) EXPERIENCED BRAIN STEM INFARCTION AND TOTAL THROMBOSIS OF THE BASILAR ARTERY AND RIGHT ANTERIOR INFERIOR CEREBELLAR ARTERY 6 MONTHS AFTER STENT IMPLANTATION. THE PATIENT HAD PRESENTED PRIOR TO STENTING WITH INTERMITTENT POSTERIOR HEADACHE AND NECK PAIN FOR 1 MONTH. MR IMAGING AND RIGHT VERTEBRAL ANGIOGRAMS REVEALED A PARTIALLY THROMBOSED FUSIFORM ANEURYSM OF THE BASILAR TRUNK. THE RIGHT ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) ORIGINATED FROM THE LOWER PART OF THE ANEURYSMAL SAC. STENT-ASSISTED COILING WAS PERFORMED TO PARTIALLY OCCLUDE THE ANEURYSM, WITH PRESERVATION OF THE RIGHT AICA. THE PATIENT DEVELOPED RIGHT HEMIPLEGIA 2 MONTHS AFTER EMBOLIZATION. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY OBTAINED 6 MONTHS LATER CONFIRMED DELAYED TOTAL THROMBOSIS OF THE REMNANT ANEURYSMAL SAC. THE PATIENT STILL SUFFERED FROM MODERATE DISABILITY AT 15 MONTH CLINICAL FOLLOW-UP WITH MRS 4. NO FURTHER PATIENT, DEVICE OR PROCEDURE INFORMATION WAS PROVIDED. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) FOLLOWING RECONSTRUCTIVE ENDOVASCULAR TREATMENT (EVT) WITH STENT(S). THEY RETROSPECTIVELY IDENTIFIED 21 PATIENTS WITH SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VBDAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE EVT BETWEEN SEPTEMBER 2009 AND SEPTEMBER 2013 AT ONE FACILITY. THERE WERE 20 MEN AND 1 WOMAN, WITH A MEAN AGE OF 46.5 YEARS (RANGE: 17¿67 YEARS). TEN PATIENTS HAD SOLE STENTING AND 11 PATIENTS HAD STENT-ASSISTED COILING WITH USE OF EITHER ENTERPRISE, SOLITAIRE OR NEUROFORM STENT(S). IN 14 CASES, THE POST-PROCEDURAL PROCESSES WERE UNEVENTFUL AND NO COMPLICATION WAS OBSERVED. THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS COULD NOT BE OBTAINED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. STROKE AND THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE ENTERPRISE STENT AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU). THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED WITHOUT BASED ON THE INFORMATION PROVIDED; HOWEVER, THE IFU CAUTIONS: ¿THE USE OF THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE IN PATIENTS IN WHOM ANTIPLATELET AND OR ANTICOAGULANT THERAPY IS CONTRAINDICATED COULD RESULT IN A HIGHER RISK OF THROMBOSIS¿. IN ADDITION, THE IFU RECOMMENDS AN ANTIPLATELET REGIMEN FOR PRE AND POST PROCEDURE. THE IFU FURTHER CAUTIONS: ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED. THERE IS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 2 MDRS BEING SUBMITTED FOR THIS COMPLAINT, WITH ASSOCIATED REFERENCE NUMBERS OF 1226348-2017-00034 AND 1226348-2017-00033.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LITERATURE ARTICLE IS ATTACHED TO THIS MDR REPORT: MU, S., LI C., YANG, X. ET AL. (2016). RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES. CLIN NEURORADIOL. (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. SINCE THE LOT NUMBER WAS NOT PROVIDED, DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE DATE OF THE EVENT WAS ALSO UNKNOWN. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL; HOWEVER, IT IS ANTICIPATED THAT ADDITIONAL INFORMATION MAY BE AVAILABLE. WHEN ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS 1 OF 2 MDRS BEING SUBMITTED FOR THIS COMPLAINT, WITH ASSOCIATED REFERENCE NUMBERS OF 1226348-2017-00034 AND 1226348-2017-00033.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOMES¿ BY S. MU, C. LI, X. YANG, Y. WANG, Y. LI, C. JIANG, AND Z. WU, PUBLISHED CLIN NEURORADIOL (2016) 26:291¿300, DOI 10.1007/S00062-014-0369-4, IT WAS REPORTED THAT POST IMPLANTATION OF A TWO UNKNOWN ENTERPRISE STENTS DURING STENT ASSISTED COIL EMBOLIZATION, THE PATIENT (CASE 14) EXPERIENCED BRAIN STEM INFARCTION AND TOTAL THROMBOSIS OF THE BASILAR ARTERY AND RIGHT ANTERIOR INFERIOR CEREBELLAR ARTERY 6 MONTHS AFTER STENT IMPLANTATION. THE PATIENT HAD PRESENTED PRIOR TO STENTING WITH INTERMITTENT POSTERIOR HEADACHE AND NECK PAIN FOR 1 MONTH. MR IMAGING AND RIGHT VERTEBRAL ANGIOGRAMS REVEALED A PARTIALLY THROMBOSED FUSIFORM ANEURYSM OF THE BASILAR TRUNK. THE RIGHT ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) ORIGINATED FROM THE LOWER PART OF THE ANEURYSMAL SAC. STENT-ASSISTED COILING WAS PERFORMED TO PARTIALLY OCCLUDE THE ANEURYSM, WITH PRESERVATION OF THE RIGHT AICA. THE PATIENT DEVELOPED RIGHT HEMIPLEGIA 2 MONTHS AFTER EMBOLIZATION. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY OBTAINED 6 MONTHS LATER CONFIRMED DELAYED TOTAL THROMBOSIS OF THE REMNANT ANEURYSMAL SAC. THE PATIENT STILL SUFFERED FROM MODERATE DISABILITY AT 15 MONTH CLINICAL FOLLOW-UP WITH MRS 4. NO FURTHER PATIENT, DEVICE OR PROCEDURE INFORMATION WAS PROVIDED. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) FOLLOWING RECONSTRUCTIVE ENDOVASCULAR TREATMENT (EVT) WITH STENT(S). THEY RETROSPECTIVELY IDENTIFIED 21 PATIENTS WITH SPONTANEOUS SYMPTOMATIC LARGE OR GIANT VBDAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE EVT BETWEEN SEPTEMBER 2009 AND SEPTEMBER 2013 AT ONE FACILITY. THERE WERE 20 MEN AND 1 WOMAN, WITH A MEAN AGE OF 46.5 YEARS (RANGE: 17¿67 YEARS). TEN PATIENTS HAD SOLE STENTING AND 11 PATIENTS HAD STENT-ASSISTED COILING WITH USE OF EITHER ENTERPRISE, SOLITAIRE OR NEUROFORM STENT(S). IN 14 CASES, THE POST-PROCEDURAL PROCESSES WERE UNEVENTFUL AND NO COMPLICATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200049 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| S