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Model Number HERO 1001 |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Fistula (1862); Hemorrhage/Bleeding (1888); Occlusion (1984); Reocclusion (1985); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)
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Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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According to the publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 007.Patient 007 was a male who received a hero implant on (b)(6) 2012 and required 11 separate vascular interventions (thrombectomy and or/angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2012.The patient was also treated on (b)(6) 2012 for "fistula bleeding.".
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Manufacturer Narrative
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According to the publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 007.Patient 007 was a male who received a hero implant on (b)(6) 2012 and required 11 separate vascular interventions (thrombectomy and or/angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012.The patient was also treated on (b)(6) 2012 for "fistula bleeding." the manufacturing records for lot h15av003 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Patient 007 had a hero graft implanted on (b)(6) 2012.The patient required eleven interventions (thrombectomy and/or angioplasty) to maintain patency from january through november of 2012.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft ifu.Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The patient was also hospitalized on (b)(6) 2012 for "fistula bleeding." the details of the bleeding were not provided.If the source was a pre-existing fistula, this event was unrelated to the hero graft implant.The specific relationship between the hero graft and the interventions and the hero graft and the bleeding cannot be assessed at this time based on the limited available information.A definitive root cause for the reported events cannot be determined, however, thrombosis/occlusion are known potential complications of all av grafts.
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Event Description
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According to the publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 007.Patient 007 was a male who received a hero implant on (b)(6) 2012 and required 11 separate vascular interventions (thrombectomy and or/angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012.The patient was also treated on (b)(6) 2012 for "fistula bleeding.".
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Search Alerts/Recalls
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