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

Model Number HERO 1002

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the report, over the past three years, the radiologist has had to recanalize the hero graft in 2-3 patients.This report represents the second of three patients.

Manufacturer Narrative

According to the report, over the past three years the radiologist has had to recannulize the hero graft in 2-3 patients.This report represents the second of three patients.Although hero 1002 is listed as the product code, both hero 1001 and hero 1002 were investigated.Multiple attempts were made to contact the complainant for additional information; however, all attempts were unsuccessful.Manufacturing records could not be reviewed as lot numbers were not provided.Possible lot numbers could not be determined as dates of implant were unknown.A review was performed of the available information.Two to three patients required "re-cannulized" hero grafts "over the last 3 years." clarification on what was meant by "re-cannulization" was not confirmed.The complaint is most likely describing cases of a hero graft thrombosis/occlusion.Thrombosis is the most common cause of vascular access dysfunction; 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 following information was not available: patient medical history, implant operative notes, and intervention operative notes.The specific relationship between the hero graft and the cases of patients requiring "re-cannulized" hero grafts cannot be assessed at this time without additional information.The ifu lists the following potential complications with the use of the hero graft: prosthesis failure, and 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 non-compliance with anticoagulation medication.".

Event Description

According to the report, over the past three years the radiologist has had to recannulize the hero graft in 2-3 patients.This report represents the second of three patients.

• 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: 5021205
• MDR Text Key: 23707618
• Report Number: 1063481-2015-00173
• 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: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• 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