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, two patients had repeat thrombosis and thigh access was placed as new access point instead of hero graft.This report represents the first of the two patients.Although the medwatch is submitted for product code hero 1001, both hero 1001 and hero 1002 are investigated.

Manufacturer Narrative

According to the report, two patients had repeat thrombosis and thigh access was placed as new access point instead of hero graft.This report represents the first of the two patients.Although the medwatch is submitted for product code hero 1001, both hero 1001 and hero 1002 are investigated.Multiple attempts were made to gather additional information regarding patient co-morbidities and/or operative notes for each case performed, when thrombosis was first noticed in the patients, how quickly after implant the thrombosis occurred, and lot numbers of implanted hero grafts.However, all attempts were unsuccessful.A review of manufacturing records could not be performed as lot numbers for the hero devices are unknown.The dates of implant 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.A surgeon reported two hero graft patients had repeat thrombosis events, which required thigh access placement to replace the hero graft.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.These patients were observed over the last five years.The only patient history provided was a note that all patients were over 65 years old and two of the four patients had diabetes.Patient specific details on the events, including implant/intervention notes, were not provided.The specific relationship between the hero graft and the reported occlusions cannot be assessed at this time without additional information.The root cause for the reported event is unknown; however, thrombosis is a known potential complication of the hero graft.The ifu lists partial stenosis or full occlusion of prosthesis or vasculature as a potential complication of the hero graft device.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 non-compliance with anticoagulation medication.".

Event Description

According to the report, two patients had repeat thrombosis and thigh access was placed as new access point instead of hero graft.This report represents the first of the two patients.Although the medwatch 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: 5033134
• MDR Text Key: 24167723
• Report Number: 1063481-2015-00204
• 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: 07/27/2015

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• 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