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

Model Number HERO 1001

Device Problems Occlusion Within Device (1423); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Unspecified Infection (1930); Occlusion (1984); 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 (b)(6).Patient (b)(6) was a male who received a hero implant on (b)(6) 2011.The patient experienced the following adverse events: hospitalized on (b)(6) 2011 for "r thigh abscess, cellulitis from dysfunctional r femoral av graft and removal of infected graft on (b)(6) 2011" deemed to be associated with "infected nonfunctioning graft" and an "old femoral graft that had been previously tied off.The site was abscessed." a wound culture on (b)(6) 2011 was positive for staph and blood culture on (b)(6) 2011 was negative.The patient hospitalized on (b)(6) 2012 for "access related" infection.Wound cultures on (b)(6) 2012 were isolate for "+acinetobacter baumannii and +morganelli morganii," blood cultures on (b)(6) 2012 isolated coagulase neg staphylococcus, and blood cultures on (b)(6) 2012 were returned negative.The patient was also treated on (b)(6) 2011 for ligation of a "malfunctioning right femoral av graft" and thrombectomy/angioplasty on (b)(6) 2012 for a "clotted av hero 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)(6).Patient (b)(6) was a male who received a hero implant on (b)(6) 2011.The patient experienced the following adverse events: hospitalized on (b)(6) 2011 for "r thigh abscess, cellulitis from dysfunctional r femoral av graft and removal of infected graft on (b)(6) 2011" deemed to be associated with "infected nonfunctioning graft" and an "old femoral graft that had been previously tied off.The site was abscessed." a wound culture on (b)(6) 2011 was positive for staph and blood culture on (b)(6) 2011 was negative.The patient hospitalized on (b)(6) 2012 for "access related" infection.Wound cultures on (b)(6) 2012 were isolate for "+acinetobacter baumannii and +morganelli morganii," blood cultures on (b)(6) 2012 isolated coagulase neg staphylococcus, and blood cultures on (b)(6) 2012 were returned negative.The patient was also treated on (b)(6) 2011 for ligation of a "malfunctioning right femoral av graft" and thrombectomy/angioplasty on (b)(6) 2012 for a "clotted av hero graft." the manufacturing records for lots 0001401 and 0001416 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was hospitalized twice, required two interventions, and experienced two incidents of infection while on study.In (b)(6) 2011 a malfunctioning right femoral arteriovenous graft (avg) required ligation; this incident was unrelated to hero graft implant.In (b)(6) 2011, the patient was hospitalized for right thigh abscess and cellulitis from the same dysfunctional avg.The femoral avg was explanted on (b)(6) 2011.Wound cultures from explant site were positive for staph, but blood cultures were negative.This event was also unrelated to the hero graft implant.In (b)(6) 2012, the patient was hospitalized for an "access-related" infection.Wound cultures were isolated for "+acinetobacter baumannii and +morganelli morganii," and blood cultures were isolated for coagulase neg staphylococcus; blood cultures a few days later were negative.The hero graft ifu lists infection as a potential complication and infection is a known complication of 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.The patient initially developed a right thigh abscess and cellulitis related to the avg.The avg was removed however it is unknown if the thigh infection was completely resolved prior to the appearance of the access­related infection.The source of the organisms detected in the access-related infection is unknown; however the hero graft is an unlikely source as it undergoes a validated sterilization process and it had been implanted for approximately six months prior to the infection.In (b)(6) 2012 the patient also required a thrombectomy/angioplasty procedure for a "clotted hero graft." partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft ifu.The specific relationship between the hero graft and the access-related infection and 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, thrombosis/occlusion and the access-related infection 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)(6).Patient (b)(6) was a male who received a hero implant on (b)(6) 2011.The patient experienced the following adverse events: hospitalized on (b)(6) 2011 for "r thigh abscess, cellulitis from dysfunctional r femoral av graft and removal of infected graft on (b)(6) 2011" deemed to be associated with "infected nonfunctioning graft" and an "old femoral graft that had been previously tied off.The site was abscessed." a wound culture on (b)(6) 2011 was positive for staph and blood culture on (b)(6) 2011 was negative.The patient hospitalized on (b)(6) 2012 for "access related" infection.Wound cultures on (b)(6) 2012 were isolate for "+acinetobacter baumannii and +morganelli morganii," blood cultures on (b)(6) 2012 isolated coagulase neg staphylococcus, and blood cultures on (b)(6) 2012 were returned negative.The patient was also treated on (b)(6) 2011 for ligation of a "malfunctioning right femoral av graft" and thrombectomy/angioplasty on 01/13/2012 for a "clotted av hero 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: 5032258
• MDR Text Key: 24128714
• Report Number: 1063481-2015-00154
• 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
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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: 0001401, 0001416
• 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