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

Model Number HERO 1001

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Swelling (2091); 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 011.Patient 011 was a female who received a hero implant on (b)(6) 2011 and required treatment on (b)(6) 2012 for a pseudoaneurysm.The patient was also hospitalized on (b)(6) 2012 for "chest pain, abnormal ekg, elevated troponin" and on (b)(6) 2012 for "sent to er for swelling of graft.".

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 treatment on (b)(6) 2012 for a pseudoaneurysm.The patient was also hospitalized on (b)(6) 2012 for "chest pain, abnormal ekg, elevated troponin" and on (b)(6) 2012 for "sent to er for swelling of graft." the manufacturing records for lots 0001264 and 0001269 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 was hospitalized twice and required one intervention while on study.The patient was hospitalized in (b)(6) 2012 for "chest pain, abnormal ekg, elevated troponin." these clinical findings are consistent with myocardial infarction, which was most likely the source of the chest pain and was likely unrelated to the hero graft.The patient was hospitalized in (b)(6) 2012 for "swelling of graft." this patient had a pseudoaneurysm documented during the period of hospitalization, which required an unspecified treatment which restored flow.Edema and pseudoaneurysm are listed on the hero graft ifu as potential vascular graft and catheter complications.As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.The specific relationship between the hero graft and the intervention cannot be assessed at this time based on the limited available information.A definitive root cause for the reported events cannot be determined, however, pseudoaneurysm and edema formation 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 treatment on (b)(6) 2012 for a pseudoaneurysm.The patient was also hospitalized on (b)(6) 2012 for "chest pain, abnormal ekg, elevated troponin" and on (b)(6) 2012 for "sent to er for swelling of graft.".

• 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: 5034270
• MDR Text Key: 24206081
• Report Number: 1063481-2015-00158
• 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: 0001264, 0001269
• 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