MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Respiratory Distress (2045)

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

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 037.Patient 037 was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for vaginal infection and missed dialysis sessions, and on (b)(6) 2013 due to complications resulting from dialysis noncompliance.The patient also received treatment on (b)(6) 2012 for a "malfunctioning av graft." the patient died on (b)(6) 2013 and cause of death was ruled respiratory arrest.

Manufacturer Narrative

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).(b)(6) was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for vaginal infection and missed dialysis sessions, and on (b)(6) 2013 due to complications resulting from dialysis noncompliance.The patient also received treatment on (b)(6) 2012 for a "malfunctioning av graft." the patient died on (b)(6) 2013 and cause of death was ruled respiratory arrest.The manufacturing records for lots 0001753 and 0001744 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.(b)(6) had a hero graft implanted on (b)(6) 2012.The patient was hospitalized four times and required one vascular intervention while on study.In (b)(6) 2012 the patient was hospitalized for a vaginal infection and missed dialysis sessions.This incident was unrelated to hero graft implant.Between (b)(6) 2013 the patient was hospitalized three times due to missed dialysis sessions, resulting in fluid overload.These incidents were also unrelated to the hero graft and were related to dialysis noncompliance.The patient also required an unspecified treatment for a "malfunctioning av graft" in (b)(6) 2012, which restored flow.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.On (b)(6) 2013 the patient died of respiratory arrest; additional details regarding the death were not provided.Death is listed in the hero graft ifu as a potential intraoperative and post-operative complication, however, the authors did not believe the death was hero­ related.The specific relationship between the hero graft and the intervention cannot be assessed at this time based on the available information.

Event Description

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).(b)(6) was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for vaginal infection and missed dialysis sessions, and on (b)(6) 2013 due to complications resulting from dialysis noncompliance.The patient also received treatment on (b)(6) 2012 for a "malfunctioning av graft." the patient died on (b)(6) 2013 and cause of death was ruled respiratory arrest.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5034425
• MDR Text Key: 24244679
• Report Number: 1063481-2015-00166
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: 0001753, 0001744
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization