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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problem 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 report, the surgeon has seen patients regularly (some almost quarterly) for hero graft thrombectomies over the last few years.Two patients have repeated thrombectomies on their hero graft.This report represents the second of the two patients.Although the report is filed for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.

Manufacturer Narrative

According to the report, the surgeon has seen patients regularly (some almost quarterly) for hero graft thrombectomies over the last few years.Two patients have repeated thrombectomies on their hero graft.This report represents the second of the two patients.Although the report is filed for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.The surgeon was contacted for additional information.He stated that "he would not be able to provide further information as to lot numbers, implant dates, patient information, etc.As he did not perform the implants." he did state that the patients had hypercoagulable states and the thrombosis was likely due to that instead of any issue with the hero graft.A review of manufacturing records could not be performed as lot numbers for the hero devices are unknown.The dates of implant and hospital(s) where the implants occurred are unknown; therefore, shipping records could not be queried for possible lot numbers shipped to the hospital(s).A review was performed of the available information.The surgeon reported hero graft patients who required multiple thrombectomy procedures.The surgeon noted that the patients were observed from 2013 to present.The patients were seen regularly; some of the patients were described as requiring interventions quarterly.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 surgeon confirmed "that the patients had hypercoagulable states and the thrombosis was likely due to that instead of any issue with the hero graft." the specific relationship between the hero graft and the reported thromboses cannot be assessed at this time without additional information.The ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature.The ifu states "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 noncompliance with anticoagulation medication.".

Event Description

According to the report, the surgeon has seen patients regularly (some almost quarterly) for hero graft thrombectomies over the last few years.Two patients have repeated thrombectomies on their hero graft.This report represents the second of the two patients.Although the report is filed for product code hero 1001, both product codes 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: 5041695
• MDR Text Key: 24534730
• Report Number: 1063481-2015-00210
• 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
• Reporter Occupation: Physician
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• 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: 08/05/2015
• 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