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

Model Number HERO 1002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

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, four patients experienced an infections that required removal of the hero graft.1 was a primary graft infection and 3 secondary infections from other primary sites.As it is unknown which component, if any, of the hero graft attributed ot the adverse event it was decided out of an abundance of caution to investigate both.This report represents the hero 1002 component.

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, four patients experienced an infections that required removal of the hero graft.One was a primary graft infection and three secondary infections from other primary sites.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 cryolife representative on 12/18/2014; to which no response was received.Information was again requested from cryolife representative on 1/12/2015.He responded that he reached out by email and phone to contact dr.(b)(6) access coordinator; she indicated she will compile all available information.Cryolife representative emailed the access coordinator again on 1/20/2015 requesting additional information.She responded that she was working on it.The access coordinator emailed the cryolife representative on 1/23/2015 giving the date of implant and the date of intervention for each patient.She stated, "that is all i can get for you." additional information was received on 1/23/2015.For patient one, the primary graft infection, the date of implant was (b)(6) 2012 and the date of removal was (b)(6) 2013.For patient two, the date of implant was (b)(6) 2013 and the removal date is unknown as it was performed at another hospital.For patient three, the date of implant was (b)(6) 2012 and the date of removal was (b)(6) 2013.For patient four, the date of implant was (b)(6) 2012 and the date of removal was (b)(6) 2013.A query was performed for all lot numbers shipped to the hospital from (b)(6) 2012 to (b)(6) 2013 to determine possible lot numbers that could have been used during the event.Fifteen possible lot numbers were identified for hero 1001:0001603, 0001763, 0001764, 0001791, 0001801, 0001802, 0001806, 0001809, 0001825, 0001859, 0001872, 0001873, 0001886, 0001887, and 0001899.Twelve possible lot numbers were identified for hero 1002: 0001612, 0001765, 0001782, 0001805, 0001839, 0001850, 0001871, 0001898, 0001917, 0001918, 0001923, and 000193.The manufacturing records for the 27 possible lot numbers (both hero 1001 and hero 1002) 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 ifu lists infection as a potential complication.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Infection is a known complication of prosthetic arteriovenous (av) grafts.They are frequently associated with cannulation sites but is most likely not in this situation given the close proximity to the arterial anastomosis.A focal graft infection can be clinically managed via surgical revision and antibiotic therapy as was done with this patient.Given the limited information available it is still unclear what the source of the infection was as there are many factors that could have contributed to the reported event: patient co­ morbidities, placement of a hemodialysis catheter, prior or ongoing systemic infection and/or wound infection.All of the patients reported in this series had procedure modification to include flixene graft attached to a small portion of the agc.The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with a flixene graft have not been evaluated by cryolife.However, flixene is an approved medical device to be used for arterio-venous (av) access so one would anticipate similar clinical outcomes, including anticipated adverse events and/or failure reported event.According to the information available in the article, four patients experienced infection following implantation of the hero device.One infection was reported as a primary graft infection.The article does not provide a definition of a primary graft infection; therefore, it is unclear whether the infection involved the arterial graft (flixene) or the voc.Infection of arterial grafts utilized for cannulation is a known potential complication of dialysis access.The article is also unclear what is meant by secondary graft infection.It is presumed that these events represent an infection that originated elsewhere and secondarily infected the graft.Without information about the source of the infection, type of infection, patient comorbidities, and/or pre­ existing infections, the relationship of the infection to the hero graft device and the patient cannot be determined.Infection is a known potential complication listed in the hero graft instructions for use (ifu).The hero graft ifu contraindicates use of the hero device in patients with known preexisting bacteremia.In addition, instructions for screening blood cultures to rule out asymptomatic bacteremia and recommended antibiotic therapy are also provided in the ifu.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, four patients experienced an infections that required removal of the hero graft.One (1) was a primary graft infection and 3 secondary infections from other primary sites.As it is unknown which component, if any, of the hero graft attributed ot the adverse event it was decided out of an abundance of caution to investigate both.This report represents the hero 1002 component.

• 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: 4357189
• MDR Text Key: 5200497
• Report Number: 3006945290-2014-00108
• 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

• 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
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2015
• 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