BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7471654 · Received April 29, 2018

    Report

    Report Number
    1226348-2018-00549
    Event Type
    Injury
    Date Received
    April 29, 2018
    Date of Event
    December 31, 2015
    Report Date
    April 3, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS LITERATURE ARTICLE AND SUBSEQUENT COMPLAINT WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW (PMS) OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ¿CEREBRAL ANEURYSM NECK DIAMETER IS AN INDEPENDENT PREDICTOR OF PROGRESSIVE OCCLUSION AFTER STENT-ASSISTED COILING.¿ MASAHITO NAKAZAKI-TADASHI NONAKA-TATSUFUMI NOMURA-TOSHIYUKI ONDA-YASUYUKI YONEMASU-AKIRA TAKAHASHI-YUJI HASHIMOTO-OSAMU HONDA-SHINICHI OKA-MASANORI SASAKI-MASAHIKO DAIBO-OSAMU HONMOU - ACTA NEUROCHIRURGICA - 2017 ACTA NEUROCHIR (2017) 159: 1313-1319 (DOI 10.1007/S00701-017-3199-8). THE ARTICLE WAS ACCEPTED ON 24 APRIL 2017 AND PUBLISHED ONLINE ON 9 MAY 2017. THE STUDY WAS CONDUCTED FROM OCTOBER 2010 TO DECEMBER 2015. THE EXACT EVENT DATE IS NOT KNOWN; THEREFORE, THE EVENT DATE IS BEING REPORTED AS (B)(6) 2015. THIS IS ONE OF TWO MDR REPORTS BEING SUBMITTED FOR THIS LITERATURE PUBLICATION. THIS REPORT IS FOR ONE PATIENT (THROMBOSIS). THERE IS NO INFORMATION ON PATIENT DEMOGRAPHIC OR DEVICE SPECIFICS. THIS IS RELATED TO MANUFACTURER REPORT NUMBER 1226348-2018-00548. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICES WERE NOT RETURNED FOR ANALYSIS NOR WERE THE STERILE LOT NUMBERS PROVIDED TO CONDUCT A LOT HISTORY REVIEW. [COMPLAINT CONCLUSION]: AS REPORTED IN THE LITERATURE PUBLICATION ACTA NEUROCHIR (2017) 159: 1313-1319 (DOI 10.1007/S00701-017-3199-8) ¿CEREBRAL ANEURYSM NECK DIAMETER IS AN INDEPENDENT PREDICTOR OF PROGRESSIVE OCCLUSION AFTER STENT-ASSISTED COILING¿ THE PURPOSE OF THIS STUDY WAS TO IDENTIFY THE FACTORS PREDICTIVE OF PROGRESSIVE OCCLUSION OF CEREBRAL ANEURYSMS THAT WERE INCOMPLETELY EMBOLIZED WITH STENT-ASSISTED COILING. THE STUDY WAS CONDUCTED FROM OCTOBER 2010 TO DECEMBER 2015. THE MEDIAN PATIENT AGE WAS 63.4 ± 12.1 YEARS AND 88% OF THE PATIENTS WERE FEMALE. ALL PATIENT RECEIVED ASPIRIN 100MG AND CLOPIDOGREL 75MG FOR AT LEAST 7 DAYS PRIOR TO THE PROCEDURE. ALL PATIENTS UNDERWENT STENT-ASSISTED COILING UNDER GENERAL ANESTHESIA USING A BIPLANE ANGIOGRAPHIC SYSTEM AND THREE-DIMENSIONAL (3D) ROTATIONAL ANGIOGRAPHY. ALL PATIENT INTRAVENOUSLY RECEIVED 4000-5000 UNITS OF HEPARIN ADMINISTERED INTRAPROCEDURAL TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) OF 250 TO 300 S. THE APPROPRIATE STENT SIZE AND LENGTH WERE SELECTED ACCORDING TO THE LENGTH OF THE ANEURYSM NECK, AND THE LARGEST DIAMETER OF THE PARENT ARTERY. THE STENT WAS DEPLOYED TO ENSURE ARTERIAL WALL COVERAGE OF > 5MM BEYOND BOTH DISTAL AND PROXIMAL SIDE OF THE NECK. STENTING WAS PERFORMED BY JAILING TECHNIQUE; AFTER THE STENT WAS DEPLOYED, EMBOLIZATION WAS PERFORMED AND BARE PLATINUM COILS WERE IMPLANTED. THE ENTERPRISE STENT (CERENOVUS/JOHNSON & JOHNSON, (B)(4)) WAS USED IN 27 PATIENTS WITH 27 CEREBRAL SACCULAR ANEURYSMS AND THE NEUROFORM STENT (BOSTON SCIENTIFIC, (B)(4)) WAS USED ON 16 PATIENTS. AMONG THE ANALYZED PATIENTS, THERE WERE FOUR WITH SYMPTOMATIC THROMBOEMBOLIC COMPLICATIONS OBSERVED DURING THE PROCEDURE. IN THREE PATIENTS, THERE WERE TRANSIENT NEUROLOGICAL DEFICITS THAT RESOLVED WITHIN 24 HOURS. NO PROCEDURE, PATIENT, OR DEVICE SPECIFIC INFORMATION (INCLUDING CATALOG AND LOT NUMBER) WAS PROVIDED IN THE ARTICLE. THE ARTICLE DID NOT SPECIFY WHICH EVENTS OCCURRED DURING USE OF ENTERPRISE STENTS VERSUS NEUROFORM STENTS. THE ENTERPRISE STENTS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBERS ARE NOT KNOWN. NO FURTHER ANALYSES CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. THE STUDY CONCLUDED THAT NECK DIAMETER WAS AN INDEPENDENT PREDICTOR OF PROGRESSIVE OCCLUSION WITHIN 6 MONTHS AFTER THE PROCEDURE IN SACCULAR ANEURYSMS WITH INCOMPLETE OCCLUSION TREATED BY STENT-ASSISTED COILING. PROGRESSIVE OCCLUSION MIGHT BE MORE LIKELY TO OCCUR IN ANEURYSMS WITH NECK DIAMETER OF 5.5 MM OR LESS. FINAL COILING TO REMNANT NECK SPACE WITH ADEQUATE PACKING DENSITY MIGHT NOT ALWAYS BE NEEDED IN THESE ANEURYSMS. THROMBOSIS AND NEUROLOGICAL EVENTS ARE KNOWN POTENTIAL PROCEDURAL COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE STENT. PATIENT AND PHARMACOLOGICAL ISSUES MAY HAVE CONTRIBUTED TO THE EVENTS. IT IS UNKNOWN IF THERE WAS PRE-EXISTING THROMBUS PRESENT IN THE ANEURYSM OR PARENT ARTERY OR IF THE PATIENT HAD BEEN COMPLIANT WITH ANTI-PLATELET MEDICATIONS. IT IS ALSO UNKNOWN HOW MANY OF THESE PATIENTS RECEIVED THE ENTERPRISE STENT VERSUS THE NEUROFORM STENT. BASED ON MINIMAL INFORMATION PROVIDED IN THE ARTICLE AS RELATED TO THE EVENTS, THE CAUSES OF THE EVENTS CANNOT BE CONCLUSIVELY DETERMINED. ALTHOUGH NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE ENTERPRISE STENTS AND THE REPORTED EVENTS, THERE IS NO INDICATION THAT THE DEVICES DID NOT PERFORM AS INTENDED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; 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 MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS IS A CORRECTION. THE ARTICLE AND THE EVENT SPREADSHEET WERE NOT ATTACHED IN THE INITIAL MDR. THIS REPORT IS TO CORRECT THE ERROR BY ADDING THE ARTICLE AND THE SPREADSHEET. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE PUBLICATION ACTA NEUROCHIR (2017) 159: 1313-1319 (DOI 10.1007/S00701-017-3199-8) ¿CEREBRAL ANEURYSM NECK DIAMETER IS AN INDEPENDENT PREDICTOR OF PROGRESSIVE OCCLUSION AFTER STENT-ASSISTED COILING¿ THE PURPOSE OF THIS STUDY WAS TO IDENTIFY THE FACTORS PREDICTIVE OF PROGRESSIVE OCCLUSION OF CEREBRAL ANEURYSMS THAT WERE INCOMPLETELY EMBOLIZED WITH STENT-ASSISTED COILING. THE STUDY WAS CONDUCTED FROM OCTOBER 2010 TO DECEMBER 2015. THE MEDIAN PATIENT AGE WAS 63.4 ± 12.1 YEARS AND 88% OF THE PATIENTS WERE FEMALE. ALL PATIENT RECEIVED ASPIRIN 100MG AND CLOPIDOGREL 75MG FOR AT LEAST 7 DAYS PRIOR TO THE PROCEDURE. ALL PATIENTS UNDERWENT STENT-ASSISTED COILING UNDER GENERAL ANESTHESIA USING A BIPLANE ANGIOGRAPHIC SYSTEM AND THREE-DIMENSIONAL (3D) ROTATIONAL ANGIOGRAPHY. ALL PATIENT INTRAVENOUSLY RECEIVED 4000-5000 UNITS OF HEPARIN ADMINISTERED INTRAPROCEDURE TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) OF 250 TO 300 S. THE APPROPRIATE STENT SIZE AND LENGTH WERE SELECTED ACCORDING TO THE LENGTH OF THE ANEURYSM NECK, AND THE LARGEST DIAMETER OF THE PARENT ARTERY. THE STENT WAS DEPLOYED TO ENSURE ARTERIAL WALL COVERAGE OF > 5MM BEYOND BOTH DISTAL AND PROXIMAL SIDE OF THE NECK. STENTING WAS PERFORMED BY JAILING TECHNIQUE; AFTER THE STENT WAS DEPLOYED, EMBOLIZATION WAS PERFORMED AND BARE PLATINUM COILS WERE IMPLANTED. THE ENTERPRISE STENT (CERENOVUS/JOHNSON & JOHNSON, (B)(4)) WAS USED IN 27 PATIENTS WITH 27 CEREBRAL SACCULAR ANEURYSMS AND THE NEUROFORM STENT (BOSTON SCIENTIFIC, (B)(4)) WAS USED ON 16 PATIENTS. AMONG THE ANALYZED PATIENTS, THERE WERE FOUR WITH SYMPTOMATIC THROMBOEMBOLIC COMPLICATIONS OBSERVED DURING THE PROCEDURE. IN THREE PATIENTS, THERE WERE TRANSIENT NEUROLOGICAL DEFICITS THAT RESOLVED WITHIN 24 HOURS. NO PROCEDURE, PATIENT, OR DEVICE SPECIFIC INFORMATION (INCLUDING CATALOG AND LOT NUMBER) WAS PROVIDED IN THE ARTICLE. THE ARTICLE DID NOT SPECIFY WHICH EVENTS OCCURRED DURING USE OF ENTERPRISE STENTS VERSUS NEUROFORM STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314293 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening