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

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pseudoaneurysm (2605)

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 033.Patient 033 was a female who received a hero implant on (b)(6) 2012 and experienced the following adverse events: hospitalized on (b)(6) 2012 for "(b)(6) infection of perm cath" that was deemed "access related," treated on (b)(6) 2012 with thrombectomy/angioplasty for occlusion, treated on (b)(6) 2012 for pseudoaneurysm, hospitalized on (b)(6) 2012 for "graft infection (b)(6)" deemed "access related," (b)(6) 2012 for "sirs av graft infection," and hospitalized on (b)(6) 2015 for "(b)(6) sm+cocci." the hero graft was explanted on (b)(6) 2013 due to "abscess at graft site.".

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 experienced the following adverse events: hospitalized on (b)(6) 2012 for "(b)(6) infection of perm cath" that was deemed "access related," treated on (b)(6) 2012 with thrombectomy/angioplasty for occlusion, treated on (b)(6) 2012 for pseudoaneurysm, hospitalized on (b)(6) 2012 for "graft infection (b)(6)" deemed "access related," (b)(6) 2012 for "sirs av graft infection," and hospitalized on (b)(6) 2015 for "(b)(6)." the hero graft was explanted on (b)(6) 2013 due to "abscess at graft site." the manufacturing records for lots 0001316 and 0001315 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 three vascular interventions while on study.The patient was hospitalized in (b)(6) 2012 for "(b)(6) infection of perm cath" that was deemed "access related." the patient was also hospitalized for infection in (b)(6) 2012 ((b)(6)), (b)(6) 2012 ("sirs"), and (b)(6) 2013 ((b)(6)).Although exact information is not available, it appears as though the initial infection involved a perm cath that was likely used for dialysis access prior to cannulation of the hero graft.Infection is a known complication of indwelling intravenous catheters.The recurring (b)(6) infections suggest incomplete resolution of the initial perm cath-related infection and were unlikely hero graft related.The ifu states that the bridging catheter should be removed as soon as possible once the hero graft is ready to be cannulated to decrease the risk of an infection related to the bridging catheter.The hero graft ifu lists infection as a potential complication and infection is a known complication of all prosthetic avgs.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.In (b)(6) 2012 the patient required thrombectomy/angioplasty for occlusion.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 treated for a pseudoaneurysm.Pseudoaneurysm is listed on the hero graft ifu as a potential vascular graft and catheter complication.As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.The hero graft was explanted on (b)(6) 2013 due to "abscess at graft site." the source of the abscess is unknown; however, this could be related to the ongoing (b)(6) infection/colonization.The specific relationship between the hero graft and the infections, occlusion, and pseudoaneurysm 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 experienced the following adverse events: hospitalized on (b)(6) 2012 for "(b)(6) infection of perm cath" that was deemed "access related," treated on (b)(6) 2012 with thrombectomy/angioplasty for occlusion, treated on (b)(6) 2012 for pseudoaneurysm, hospitalized on (b)(6) 2012 for "graft infection (b)(6)" deemed "access related," (b)(6) 2012 for "sirs av graft infection," and hospitalized on (b)(6) 2015 for "(b)(6)." the hero graft was explanted on (b)(6) 2013 due to "abscess at graft site.".

• 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: 5034364
• MDR Text Key: 24212191
• Report Number: 1063481-2015-00163
• 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

• Date FDA Received: 08/27/2015
• 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: 0001316, 0001315
• Is the Reporter a Health Professional?: Yes
• 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