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

Model Number HERO 1001

Device Problems Complete Blockage (1094); Insufficient Information (3190)

Patient Problems Thrombosis (2100); No Information (3190)

Event Date 05/19/2015

Event Type  Injury  

Event Description

According to the notification form, standard thrombectomy after 6 weeks without complications.It is unknown which hero component is associated with the alleged event therefore both hero 1001 and hero 1002 will be investigated.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

Corrected information: patient identifier, was corrected from (b)(6).According to the notification form, a patient underwent a "standard thrombectomie after 6 weeks without complications." although this medwatch report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to gather additional information from the surgeon; however, no additional information was provided.Manufacturing records for lot numbers (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met cryolife release specifications.A review was performed of the available information.The patient had a standard thrombectomy eight weeks after hero graft implantation.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 instructions for use (ifu).The following information was not reported: operative notes, patient history, dialysis compliance, and medication history.Without medical history, the patient's personal risk of thrombosis cannot be assessed.Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Without additional information on the implant procedure and relevant patient history, the relationship between the hero graft and the thrombosis or occlusion cannot be established.The root cause for the reported event is unknown; however, thrombosis is a known potential complication of all arteriovenous grafts.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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.".

Event Description

According to the notification form, a patient underwent a "standard thrombectomie after 6 weeks without complications." although this medwatch report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.

Manufacturer Narrative

According to the notification form, a patient underwent a "standard thrombectomy after 6 weeks without complications." although this medwatch report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to gather additional information from the surgeon; however, no additional information was provided.Manufacturing records for lot numbers h15vc004 and h15av001 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met cryolife release specifications.A review was performed of the available information.The patient had a standard thrombectomy eight weeks after hero graft implantation.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 instructions for use (ifu).The following information was not reported: operative notes, patient history, dialysis compliance, and medication history.Without medical history, the patient's personal risk of thrombosis cannot be assessed.Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Without additional information on the implant procedure and relevant patient history, the relationship between the hero graft and the thrombosis or occlusion cannot be established.The root cause for the reported event is unknown; however, thrombosis is a known potential complication of all arteriovenous grafts.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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.".

Event Description

According to the notification form, a patient underwent a "standard thrombectomy after 6 weeks without complications." although this medwatch report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were 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: 4919607
• MDR Text Key: 6057045
• Report Number: 1063481-2015-00115
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H15VC004; H15AV001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• 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): Required Intervention