BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7674977 · Received July 10, 2018

    Report

    Report Number
    1226348-2018-00631
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    July 31, 2014
    Report Date
    June 27, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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: ¿LONG-TERM OUTCOME OF THE ENTERPRISE STENT IN THE TREATMENT OF WIDE-NECKED CEREBRAL ANEURYSMS.¿ BU-LANG GAG*, XUE-JING ZHANG, QIONG-YING FAN, WEI-LI HAO, CONG-HUI LI, SONG-TAO YANG. ACTA MEDICA MEDITERRANEA. 2018, 34: 99. DOI: 10.19193/0393-6384_2018_1_17. INFORMATION REGARDING PATIENT WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. THIS MDR IS BEING SUBMITTED FOR MULTIPLE PATIENTS (QUANTITY OF 4 ¿ ANEURYSM REGROWTH / RECANALIZATION) WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICES WERE NOT RETURNED FOR ANALYSES NOR WERE THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. (B)(4). [CONCLUSION]: THE LITERATURE STUDY, ¿LONG-TERM OUTCOME OF THE ENTERPRISE STENT IN THE TREATMENT OF WIDE-NECKED CEREBRAL ANEURYSMS.¿ BU-LANG GAG*, XUE-JING ZHANG, QIONG-YING FAN, WEI-LI HAO, CONG-HUI LI, SONG-TAO YANG. ACTA MEDICA MEDITERRANEA. 2018, 34: 99. DOI: 10.19193/0393-6384_2018_1_17 CAPTURED FOUR CASES OF ANEURYSM REGROWTH / RECANALIZATION IN FOUR PATIENTS THAT HAD NEAR COMPLETE OR COMPLETE OCCLUSION AFTER UNDERGOING INTRACRANIAL ANEURYSM TREATMENT WITH THE ENTERPRISE STENTS. THE FOUR PATIENTS WERE RETREATED TO COMPLETE OCCLUSION. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE SAFETY AND LONG-TERM OUTCOME OF THE ENTERPRISE STENT IN THE TREATMENT OF WIDE-NECKED INTRACRANIAL ANEURYSMS. FROM MARCH 2008 TO JULY 2017, MEDICAL CHART FROM 68 PATIENTS (46 FEMALES AND 22 MALES WITH AN AGE RANGE FROM 25-88 YEARS; MEAN AGE 56) WITH 78 WIDE-NECKED INTRACRANIAL ANEURYSMS TREATED WITH THE ENTERPRISE STENT RECONSTRUCTION OF THE PARENT ARTERY WERE RETROSPECTIVELY STUDIED FOR THE EFFICACY AND ADVERSE EFFECTS OF THE ENTERPRISE STENTING PROCEDURE. NO PATIENTS HAD ACUTE SUBARACHNOID HEMORRHAGE. THE STENTING PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA AFTER ORAL ADMINISTRATION OF A LOADING DOSE OF CLOPIDOGREL AND ASPIRIN (300 MG EACH) THREE DAYS BEFORE THE PROCEDURE. PATIENTS RECEIVED AN INITIAL HEPARIN BOLUS (70-100 UI/KG) FOLLOWED BY CONTINUOUS INFUSION TO ACHIEVE AN ACTIVATED CLOTTING TIME OF 250-300 S. ANGIOGRAPHIC DATA AND CLINICAL OUTCOMES BEFORE AND AFTER STENTING AT FOLLOW-UP WERE RETROSPECTIVELY EVALUATED. SEVENTY-SEVEN ENTERPRISE STENTS WERE SUCCESSFULLY DEPLOYED IN THE DESIRED POSITION IN THE 68 PATIENTS TO TREAT THE 78 WIDE-NECKED ANEURYSMS. THERE WERE TWELVE ANEURYSMS TREATED WITH STENT DEPLOYMENT ALONE; SIXTY-SIX ANEURYSMS WERE TREATED WITH STENT-ASSISTED COILING RESULTING IN COMPLETE OCCLUSION IN 46 ANEURYSMS, NEAR COMPLETE OCCLUSION IN 15 ANEURYSMS, AND INCOMPLETE OCCLUSION IN 5 ANEURYSMS. ONE ENTERPRISE STENT WAS USED TO COVER 2-4 ADJACENT ANEURYSMS IN 7 PATIENTS WITH THE LARGEST ANEURYSM COILED AND THE SMALLER ONES UNCOILED. ANEURYSM OCCLUSION AT POST-PROCEDURE AND AT FOLLOW-UP ANGIOGRAPHY WERE CONSIDERED COMPLETE WHEN THE ANEURYSM SAC AND NECK WERE PACKED WITH NO FILLING OF CONTRAST MATERIAL, NEAR COMPLETE WHEN THE SAC WAS OCCLUDED BUT A NECK REMNANT WAS PRESENT, AND INCOMPLETE WHEN THERE WAS PERSISTENT OPACIFICATION OF A SAC REMNANT. THERE WERE SEVEN PROCEDURE-RELATED COMPLICATIONS INCLUDING THROMBOSIS FORMATION IN TWO PATIENTS, COIL PROTRUSION IN TWO PATIENTS AND STENT DISLOCATION IN THREE PATIENTS. ALL THE PATIENTS HAD ONE OR MORE ANGIOGRAPHIC FOLLOW-UP STUDIES AT 12-55 MONTHS AFTER EMBOLIZATION. THERE WERE 32 ANEURYSMS WITH NO COMPLETE OCCLUSION (15 NEAR COMPLETE OCCLUSION + 5 INCOMPLETE OCCLUSION +12 STENTING ALONE), THERE WERE 23 INSTANCES OF PROGRESSIVE THROMBOSIS INCLUDING 8 ANEURYSMS WITH NEAR COMPLETE OCCLUSION PROGRESSING TO COMPLETE OCCLUSION. THE 12 ANEURYSMS WITH THAT UNDERWENT STENTING ALONE PROGRESSED TO COMPLETE OCCLUSION IN 6 AND A DECREASED IN SIZE IN THE OTHER 6. THERE WERE 11 PATIENTS WHO EXPERIENCED ANEURYSM REGROWTH; FOUR OF THE PATIENTS WERE RETREATED WHILE THE REMAINING 7 WERE PUT UNDER CONTINUOUS SURVEILLANCE. THE STUDY CONCLUDED THAT THE ENTERPRISE STENT RECONSTRUCTION OF THE PARENT ARTERY FOR TREATING INTRACRANIAL ANEURYSMS IS SAFE AND EFFECTIVE WITH LONG-TERM ASYMPTOMATIC IN-STENT STENOSIS. ANEURYSM REGROWTH OR RECANALIZATION IS A KNOWN COMPLICATION THAT CAN OCCUR WITH THE ENTERPRISE STENT AND COIL EMBOLIZATION PROCEDURE. THE ROOT CAUSE OF THE EVENTS CANNOT BE DETERMINED; HOWEVER, PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. ANEURYSM NECK WIDTH, ANGLE, AND COIL PACKING DENSITY MAY HAVE CONTRIBUTED TO THE RECANALIZATION. THE INSTRUCTIONS FOR USE (IFU) STATES: SELECT A STENT LENGTH THAT IS AT LEAST 10 MM LONGER THAN THE ANEURYSM NECK TO INSURE A MINIMUM OF 5 MM ON EITHER SIDE OF THE ANEURYSM NECK. THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED. THE ANEURYSM REGROWTH / RECANALIZATION EVENTS MEET MDR REPORTABILITY SINCE THEY REQUIRED INTERVENTION TO PREVENT SERIOUS INJURY. THE ENTERPRISE STENTS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBERS ARE NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. 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. THIS IS ONE OF FOUR PRODUCT EVENTS INVOLVED WITH THE LITERATURE PUBLICATION. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 1226348-2018-00628, 1226348-2018-00629, 1226348-2018-00630, AND 1226348-2018-00631.

    Description of Event or Problem · 1

    THE LITERATURE STUDY, ¿LONG-TERM OUTCOME OF THE ENTERPRISE STENT IN THE TREATMENT OF WIDE-NECKED CEREBRAL ANEURYSMS.¿ BU-LANG GAG*, XUE-JING ZHANG, QIONG-YING FAN, WEI-LI HAO, CONG-HUI LI, SONG-TAO YANG. ACTA MEDICA MEDITERRANEA; 2018, 34: 99. DOI: 10.19193/0393-6384_2018_1_17 CAPTURED FOUR CASES OF ANEURYSM REGROWTH / RECANALIZATION IN FOUR PATIENTS THAT HAD NEAR COMPLETE OR COMPLETE OCCLUSION AFTER UNDERGOING INTRACRANIAL ANEURYSM TREATMENT WITH THE ENTERPRISE STENTS. THE FOUR PATIENTS WERE RETREATED TO COMPLETE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515222 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1