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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problems Dehydration (1807); Embolism (1829); Embolus (1830); Hemorrhage/Bleeding (1888); Thrombosis (2100)

Event Type  Injury  

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 013.Patient 013 was a female who received a hero implant on (b)(6) 2011 who required a thrombectomy on (b)(6) 2011 for occlusion.The patient was treated on (b)(6) 2015 for a "bleeding r femoral p cath" and hospitalized on (b)(6) 2012 for "pulmonary emboli and dehydration, no appetite.".

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) 2011 who required a thrombectomy on (b)(6) 2011 for occlusion.The patient was treated on (b)(6) 2015 for a "bleeding r femoral p cath" and hospitalized on (b)(6) 2012 for "pulmonary emboli and dehydration, no appetite." the manufacturing records for lots 0001511 and 0001611 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) 2011.The patient was hospitalized twice and required one intervention while on study.In (b)(6) 2011 the patient was treated for a "bleeding r femoral p cath." this incident was unrelated to hero graft implant.The patient also required a thrombectomy for occlusion in (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.In (b)(6) 2012 the patient was hospitalized for "pulmonary emboli and dehydration, no appetite." embolism is listed in the hero graft ifu as a potential intraoperative and post-operative complication.The specific relationship between the hero graft and the intervention and to the pulmonary emboli cannot be assessed at this time based on the available information.A definitive root cause for the reported events cannot be determined, however, pseudoaneurysm and pulmonary emboli are known potential complications listed in the ifu.

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) 2011 who required a thrombectomy on (b)(6) 2011 for occlusion.The patient was treated on (b)(6) 2015 for a "bleeding r femoral p cath" and hospitalized on (b)(6) 2012 for "pulmonary emboli and dehydration, no appetite.".

• 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: 5034298
• MDR Text Key: 24210265
• Report Number: 1063481-2015-00159
• 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: 0001511, 0001611
• 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): Hospitalization; Other