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Model Number HERO 1001 |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Occlusion (1984); Reocclusion (1985); Thrombosis (2100); Virus (2136)
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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 006.Patient 006 was a female who received a hero implanted in two stages, the arterial graft component (agc) on (b)(6) 2011 and the venous outflow component (voc) on (b)(6) 2011.They required 4 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency on (b)(6) 2011.The patient was also hospitalized on (b)(6) 2012 for respiratory syncytial virus.
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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 (b)(4).Patient (b)(4) was a female who received a hero implanted in two stages, the arterial graft component (agc) on (b)(6) 2011 and the venous outflow component (voc) on (b)(6) 2011.They required 4 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency on (b)(6) 2011.The patient was also hospitalized on (b)(6) 2012 for respiratory syncytial virus.The manufacturing records for lot 0001483 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Patient (b)(4) had a hero graft implanted in two stages; the agc was implanted on (b)(6) 2011 and the voc was implanted on (b)(6) 2011.The patient required four interventions (thrombectomy and/or angioplasty) to maintain patency from (b)(6) 2011.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 in (b)(6) 2012 for rsv which is a common respiratory virus.Transmitted by inhalation of infectious aerosols and is in no way related to the hero graft.The specific relationship between the hero graft and the interventions 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 (b)(4).Patient (b)(4) was a female who received a hero implanted in two stages, the arterial graft component (agc) on (b)(6) 2011 and the venous outflow component (voc) on (b)(6) 2011.They required 4 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency on (b)(6) 2011.The patient was also hospitalized on (b)(6) 2012 for respiratory syncytial virus.
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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 (b)(6).Patient (b)(6) was a female who received a hero implanted in two stages, the arterial graft component (agc) on (b)(6) 2011 and the venous outflow component (voc) on (b)(6) 2011.They required 3 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency on (b)(6) 2011.These dates of interventions have been clarified by the hospital.The patient was also hospitalized on (b)(6) 2012 for respiratory syncytial virus (rsv).Date of interventions has been updated to include the corrections.The manufacturing records for lot 0001483 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Patient (b)(6) had a hero graft implanted in two stages; the agc was implanted on (b)(6) 2011 and the voc was implanted on (b)(6) 2011.The patient required three interventions (thrombectomy and/or angioplasty) to maintain patency (b)(6) 2011.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 in (b)(6) 2012 for rsv, a common respiratory virus transmitted by inhalation of aerosols and is in no way related to the hero graft.The specific relationship between the hero graft and the interventions cannot be assessed at this time without additional information.
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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 (b)(6).Patient (b)(6) was a female who received a hero implanted in two stages, the arterial graft component (agc) on (b)(6) 2011 and the venous outflow component (voc) on (b)(6) 2011.They required 3 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency on (b)(6) 2011.These dates of interventions have been clarified by the hospital.The patient was also hospitalized on (b)(6) 2012 for respiratory syncytial virus (rsv).Dates of interventions has been updated.
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Search Alerts/Recalls
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