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); Appropriate Term/Code Not Available (3191)

Patient Problems Atrial Fibrillation (1729); Death (1802); High Blood Pressure/ Hypertension (1908); Vascular System (Circulation), Impaired (2572); Test Result (2695); No Code Available (3191)

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 039.Patient 039 was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for "positive troponins, atrial fibrillation, moderate to severe pulmonary hypertension" and received a "banding procedure" on (b)(6) 2012 for "steal." no additional information is available at this time regarding the date or cause of death.

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)(6).Patient 039 was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for "positive troponins, atrial fibrillation, moderate to severe pulmonary hypertension" and received a "banding procedure" on (b)(6) 2012 for "steal." no additional information is available at this time regarding the date or cause of death.The manufacturing records for lot 0001753 and 0001779 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)(6) had a hero graft implanted on (b)(6) 2012.The patient was hospitalized one time and required one vascular intervention while on study.In (b)(6) 2012 the patient was hospitalized for "positive troponins, atrial fibrillation, moderate to severe pulmonary hypertension".It is unclear if the hero graft was involved in the development of the aforementioned symptoms.However, cardiac arrhythmia and hypertension are listed as potential intraoperative and post-operative complications in the hero graft ifu.Four days following hospitalization the patient required a "banding procedure" for treatment of steal syndrome.The hero graft ifu lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero, and 3.8% in avgs.Steal syndrome is not unique to the hero graft and is a well-known complication of av access conduits; fistula, prosthetic, biologic and xenograft inclusive.The patient died on (b)(6) 2013 of an unknown cause.Death is listed in the hero graft ifu as a potential intraoperative and post-operative complication.Although the cause of death is unknown, the authors did not believe the death was hero­ related.The specific relationship between the hero graft and the hospitalization and steal 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 patient (b)(6).Patient(b)(6) was a female who received a hero implant on (b)(6) 2012 and was hospitalized on (b)(6) 2012 for "positive troponins, atrial fibrillation, moderate to severe pulmonary hypertension" and received a "banding procedure" on (b)(6) 2012 for "steal." no additional information is available at this time regarding the date or cause of death.

• 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: 5034500
• MDR Text Key: 24245103
• Report Number: 1063481-2015-00167
• 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: 0001753
• 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): Death; Hospitalization