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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Reocclusion (1985); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

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 008.Patient 008 was a female who received a hero implant on (b)(6) 2011 and required 5 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2011, and (b)(6) 2012.

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 patient (b)(4).Patient (b)(4) was a female who received a hero implant on (b)(6) 2011 and required 5 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2011, (b)(6) 2012.The manufacturing records for lots 0001530 and 0001501 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 on (b)(6) 2011.The patient required five interventions (thrombectomy and/or angioplasty) to maintain patency from (b)(6) 2011 through (b)(6) 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 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.

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 (b)(4).Patient (b)(4) was a female who received a hero implant on (b)(6) 2011 and required 5 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency.Known dates of procedure include (b)(6) 2011, (b)(6) 2012.

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 patient 008.Patient 008 was a female who received a hero implant on (b)(6) 2011 and required 3 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency; procedure dates of include (b)(6) 2011, (b)(6) 2012.On (b)(6) 2012 av fistulogram/diagnostic angiogram identified partial occlusion but an intervention was not performed.On (b)(6) 2012 a difficult cannulation was reported and an unknown procedure was performed.Additional clarifying information has been added to the complaint description to specify that 3 vascular interventions were performed and 1 diagnostic procedure as well as a difficult cannulation with an unknown procedure.The manufacturing records for lots 0001530 and 0001501 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Patient 008 patient 008 had a hero graft implanted on (b)(6) 2011.The patient required three interventions (thrombectomy and/or angioplasty) to maintain patency from (b)(6) 2011 through (b)(6) 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.In (b)(6) 2012 the patient had a partially occluded hero graft which required an av fistulogram/diagnostic angiogram; no anatomic problems were noted and no intervention was required.In (b)(6) 2012 the patient required an unknown intervention secondary to difficult cannulation; no additional information was provided.The specific relationship between the hero graft and the interventions, as well as the partial occlusion noted by the angiogram, cannot be assessed at this time without additional 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 patient 008.Patient 008 was a female who received a hero implant on (b)(6) 2011 and required 3 separate vascular interventions (thrombectomy and/or angioplasty) to maintain patency; procedure dates of include (b)(6) 2011, (b)(6) 2012.On (b)(6) 2012 av fistulogram/diagnostic angiogram identified partial occlusion but an intervention was not performed.On (b)(6) 2012 a difficult cannulation was reported and an unknown procedure was performed.Additional clarifying information has been added to the complaint description to specify that 3 vascular interventions were performed and 1 diagnostic procedure as well as a difficult cannulation with an unknown procedure.

• 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: 5034255
• MDR Text Key: 24202515
• Report Number: 1063481-2015-00157
• 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: 0001530, 0001501
• 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