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

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

The article is a case report in which the surgeon reports a case of intracranial hypertension following the placement of a hero graft.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.

Manufacturer Narrative

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

Manufacturer Narrative

Dr.(b)(6) requested an image of the hero graft algorithm to include in a case report that he is writing via the hero graft website on (b)(6) 2014.Cryolife followed up for more details on the same day and this is what was reported by dr.(b)(6) in he follow up email (also on (b)(6): "the article is a case report in which we report a case of intracranial hypertension following the placement of a hero graft.This complication has been in at least 12 cases of coexisting central venous stenosis and peripheral hemodialysis shunt, but has not been previously reported with a hero graft as far as i am aware.We hypothesize that there may be other factors (besides central venous stenosis and increased venous flow from a hemodialysis shunt) contributing to intracranial hypertension, such as impaired extracranial venous outflow from epidural veins." additional information was received from dr.(b)(6).Dr.(b)(6) saw the patient while he was at (b)(6) hospital, however; it is unknown at what hospital or what surgeon implanted the hero graft.It is also unknown the exact date of implant though dr.(b)(6) did say that it was sometime in (b)(6) 2014.The intracranial hypertension was suspected about three days after graft placement, but was not confirmed until (b)(6) 2014.He was never in contact with the surgeon who implanted the device and dr.(b)(6) never had any operative records available.The patient's comorbidities included insulin dependent diabetes, hypertension, and hypercholesterolemia.This is the first known report of intracranial hypertension following hero graft implant.Intracranial hypertension is a symptom of superior vena cava syndrome (svcs) according to the 2003 article by al-hilali n, nampoory mr, ninan vt, hussein fm, ali jh, samhan m, johny kv."the superior vena cava syndrome: late presentation after hemodialysis catheter removal." svcs occurs as a result of the combination of patient's anatomy (central vein stenosis and collateral vein development) along with the location of hero graft venous outflow component, potentially crowding the vessel and/or occluding the collateral vessels, and impede cerebral venous drainage, resulting in swelling of the head, face, neck or arm most often, but can also raise intracranial pressure (icp).Superior vena cava syndrome is listed in the hero graft instructions for use (ifu) as a potential complication.Svcs was not seen during the fda clinical trials for hero graft, but there was one report of edema (2.6%).This was described as mild, but it did not indicate the location of the edema.The literature rates from the hero graft clinical evaluation report list svcs in avgs = 0.8%.The reporting physician indicated that there may be factors other than the hero graft contributing to this patient's intracranial hypertension, including central venous stenosis, increased flow from a hemodialysis shunt, and impaired extracranial venous outflow from epidural veins.He also indicated the patient had multiple co-morbidities including diabetes, hypertension, and hypercholesterolemia.These co-morbidities could also have been contributing factors to raising the icp.The root cause of this complaint is most likely superior vena cava (svc) syndrome resulting in intracranial venous hypertension.Svc represents known potential complications of the hero graft which are outlined in the device's ifu.These known potential complications are common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.

Event Description

The article is a case report in which the surgeon reports a case of intracranial hypertension following the placement of a hero graft.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• 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: 4238944
• MDR Text Key: 5019109
• Report Number: 3006945290-2014-00086
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• 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