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

Model Number HERO 1002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, three patients developed thrombosis after implant of the hero graft.In the first patient the event occurred two months after implantation, in the second patient it occurred one week after implantation, and the third patient developed thrombosis three days after implantation.

Manufacturer Narrative

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

Manufacturer Narrative

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, three patients developed thrombosis after implant of the hero graft.In the first patient the event occurred two months after implantation, in the second patient it occurred one week after implantation, and the third patient developed thrombosis three days after implantation.The article accepted for publication in the annals of vascular surgery indicates that a retrospective review was performed of 21 hero graft patients and 35 femoral avg (favg) patients whose access was placed between may 2009 and february 2013.Most hero grafts (85%) were placed in the upper limb.While 40 % of hero grafts were constructed for salvage of an existing avg, the majority (60%) were placed de novo, requiring a bridging tdc.The average number of interventions per access was 1.1+/- 1.47 for favg and 1.65 +/- 2.52 for hero (p=0.35).According to table ii, there were 5 (10.6%) hero graft patients requiring surgical intervention for thrombosis compared to 8 (12.3%) of the favg group.The primary patency rates at 1 year were 18.7% for favg and 29.0% for hero (p=0.67).Secondary patency rates at 1 year were 50.6% for favg and 53.5% for hero (p= 0.69).Table 1 of the ifu shows the primary patency at one year observed in both of the pre-market clinical trials: 36.0% in the patency study and 33.3% in the bacteremia study.The rate of secondary patency at one year in both of the pre-market clinical trials was: 70.0% in the patency study and 77.8% in the bacteremia study.The intervention rate for both studies was 1.7 per year in the patency study and 2.5 per year in the bacteremia study.The ifu's patient selection considerations states: as with conventional grafts, hero graft may occlude in patients with: a small brachial artery (exp.Id less than 3 mm).Insufficient arterial inflow or inflow stenosis.A history of clotted accesses for unknown reasons.A coagulability disorder or medical condition that is associated with clotting (i.E., cancer).Insufficient anticoagulation or non-compliance with anticoagulation medication.Systemic low blood pressure or severe hypotension following fluid removal post dialysis.A kinked graft.Incomplete thrombus removal in previous interventions.Intra-graft stenosis at site of multiple punctures.An event such as mechanical compression (i.E., spring loaded hemostasis clamps).The hero graft instructions for use (ifu) lists prosthesis failure as a potential complication and states thrombosis is the most common cause of vascular access dysfunction.The report indicates that hero devices required revision including replacement with ptfe for thrombosis three days after implant, one week after implant and two months after implant.Graft occlusion or thrombosis is a known potential complication of the hero device.Clinical studies show 36% primary patency at one year and 70% secondary patency at one year.The hero instructions for use (ifu) lists patient selection considerations that could contribute to early occlusion.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, three patients developed thrombosis after implant of the hero graft.In the first patient the event occurred two months after implantation, in the second patient it occurred one week after implantation, and the third patient developed thrombosis three days after implantation.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4178920
• MDR Text Key: 5087904
• Report Number: 3006945290-2014-00080
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• 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