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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 12/13/2012

Event Type  Injury  

Event Description

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, one patient developed dialysis associated steal syndrome that required ligation.The hero graft was removed.

Manufacturer Narrative

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

Manufacturer Narrative

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, one patient developed dialysis associated steal syndrome that required ligation.The hero graft was removed.Additional information was received on 1/23/2015.The patient's date of implant was (b)(6) 2012 and the date of ligation (banding) was (b)(6) 2012.Multiple attempts were made to gain additional information, including the lot numbers, date of implant, date of adverse event, and information surrounding the events.This information was requested from the cryolife representative, on 12/18/2014; to which no response was received.Information was again requested from the representative on 1/12/2015.He responded that he reached out by email and phone to contact diane, dr.(b)(6) access coordinator; she indicated she will compile all available information.The cryolife representative emailed (b)(6) again on 1/20/2015 requesting additional information.Diane responded that she was working on it.(b)(6) emailed the representative on 1/23/2015 giving the date of implant and the date of intervention.She stated, "that is all i can get for you." a query was performed for all lot numbers shipped to the hospital for the six months prior to the date of implant, (b)(6) 2012.Three possible lot numbers were identified 0001612, 0001765, and 0001782.The manufacturing records for lots 0001612, 0001765, and 0001782 were reviewed and it was confirmed that all records were controlled available for review, and met all specifications per device master record.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication.Table 2 of the ifu shows steal syndrome ranging from 2.6% to 3.8% for hero, and 3.8% in arterio-venous graft (avg).Steal syndrome is not unique to hero graft and is a well known complication of hemodialysis conduits may be managed by ligation and/ or explant.All of the patients report in this series had procedure modification to include flixene graft attached to a small portion fo the agc.This is a modification to the device, so cryolife cannot support this modification as it is not an approved indication/ modification to the device.The ifu provides adequate instructions to implant the graft in the approved configuration but no allowance is made for off label use.Clinical outcomes with a modified device have not been evaluated by cryolife.According to the available information a patient developed steal syndrome following implant of the hero graft.Since the hero graft shunts arterial blood in the venous system steal syndrome is a known potential complication.Surgical technique could potentially increase the risk of steal syndrome.Adequate warnings and precautions are listed in the ifu.The root cause for the reported event is excessive shunting of arterial blood into the venous circulation.Steal syndrome is a known potential complication of the hero graft.The root cause for the reported event is excessive shunting of arterial blood into the venous circulation.This event 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.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, one patient developed dialysis associated steal syndrome that required ligation.The hero graft was removed.

• 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: 4357223
• MDR Text Key: 5238142
• Report Number: 3006945290-2014-00109
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• 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: 12/10/2014
• 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