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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problems Unspecified Infection (1930); Occlusion (1984)

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 report, the patient experienced infection and patency issues with the hero graft.Physician unsure if patient factors caused the complications or if they resulted from hero graft.They were able to resolve the complications in the patient.Although this medwatch report is submitted for product code hero 1001, both hero 1001 and hero 1002 are investigated.

Manufacturer Narrative

According to the report, the patient experienced infection and patency issues with the hero graft.Physician unsure if patient factors caused the complications or if they resulted from hero graft.They were able to resolve the complications in the patient.Although this medwatch report is submitted for product code hero 1001, both hero 1001 and hero 1002 are investigated.Multiple attempts were made to obtain additional information from the surgeon, including name(s) of implanting surgeons and hospital(s), information regarding patient co-morbidities and/or operative notes, when the occlusion and infection was first noticed, how quickly after implant of the hero graft the occlusion and infection occurred, if the hero graft was being cannulated, and lot numbers of implanted hero grafts.All attempts were unsuccessful.A review of manufacturing records was not performed as lot numbers for the hero devices are unknown.The date of implant and hospital where the implant occurred are unknown; therefore, shipping records could not be queried for possible lot numbers shipped to the hospital.A review was performed of the available information.The interventional nephrologist reported a case of a hero graft patient with infection and patency issues which occurred sometime in the first quarter of 2015.The physician was unsure if patient factors or the hero graft caused the observed complications; however, the complications were able to be resolved.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The hero graft ifu also lists infection as a potential complication.Infection is a known complication of prosthetic arteriovenous (av) grafts.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.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.Possible causes of secondary infection include surgical site infection or infection related to cannulation.Patient specific details on the events, including blood cultures for the infection and implant/intervention notes, were not provided.The specific relationship between the hero graft and the reported occlusions and infection cannot be assessed at this time without additional information.The ifu lists the following potential complications with the use of the hero graft: infection, and partial stenosis or full occlusion of prosthesis or vasculature.The ifu states "implantation of the hero graft is contraindicated if: the patient has a topical or subcutaneous infection associated with the implantation site; the patient has known or suspected systemic infection, bacteremia, or septicemia.Obtain screening blood cultures to rule out asymptomatic bacteremia prior to hero graft implant for any patient dialyzing on a catheter; treat patient with antibiotics per culture outcome and ensure infection is resolved prior to hero graft implant procedure.Plan for increased bacteremia risk after an ipsilateral hero graft placement or with femoral bridging catheters and treat prophylactically with antibiotics knowing patients are at higher infection risk.Prophylactically treat the patient in the peri-operative period with antibiotics based on the patients bacteremia history" and "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft." the ifu also states "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication.".

Event Description

According to the report, the patient experienced infection and patency issues with the hero graft.Physician unsure if patient factors caused the complications or if they resulted from hero graft.They were able to resolve the complications in the patient.Although this medwatch report is submitted for product code hero 1001, both hero 1001 and hero 1002 are investigated.

• 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: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5045648
• MDR Text Key: 24699193
• Report Number: 1063481-2015-00214
• 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: study
• Reporter Occupation: Physician
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2015
• 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): Other