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

Model Number HERO 1002

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

According to the report, the hero graft was explanted because the graft became infected; however, the surgeon contributes the infection to patient non - compliance and the dialysis staff.The event was not contributed to the device in any way.

Manufacturer Narrative

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

Manufacturer Narrative

According to a phone call on (b)(6) 2012 from staff at the surgeon's office, the patient had a recurrent infection near the connector region of the hero graft.The patient had a boil that was lanced and the patient was started on antibiotics.The infection recurred a month later.Again, it was drained and antibiotics were started again, but the patient is allergic to some antibiotics, so treatments of the infection were not effective.The surgeon scheduled an exploratory for later in the day.According to a phone call later in the day from the surgeon, the patient was non-compliant in taking the antibiotics.The surgeon described the area of infection as a pustule near the connector region.The surgeon was concerned that the dialysis staff may have mishandled the arterial graft portion of the hero and caused a pseudoaneurysm, or the infection was manifesting most at the skin over the connector region.The surgeon discussed the area of the connector to make sure it was not leaking and options for revision if it was.A few days later it was confirmed that the hero graft had been explanted and that the infection had extended to the graft.The surgeon made no allegation that the infection was related to the hero graft.The surgeon attributed the infection to the patient and/or the dialysis staff.The surgeon spoke to cryolife's clinical staff on (b)(6) 2014 and cryolife's clinical staff was able to obtain additional information about the patient in this complaint.The surgeon said the implant had been about six months prior to the explant.The patient was a very obese female with a history of infections.It was definitely a localized infection and typically the surgeon would excise just the infected portion and perform a jump graft around the area.In this case, since the infection was near the connector, that was not an option with the hero graft and venous outflow component (voc), so he performed the explant of the connector and voc.A clinical review of this event was performed.The hero graft instructions for use (ifu) lists infection as a potential complication.Table 1 of the ifu shows device/procedure related bloodstream infection was observed in both of the pre-market clinical trials: 0.13/1,000 days or 5.8% in the patency study (nassar, semin in dial 2014) and 0.7/1,000 days or 18.4% in the bacteremia study (katzman, jvs 2009).The rate of infection in arterio-venous graft literature is 0.11/1,000 days (percentage not available).In the post-market retrospective multi-center study, gage (ejves 2014) reported access related infections occurred at a rate of 4.3% or 0.14/1,000 implants.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 in the hero graft implant procedure section: "prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history." the hero graft faq also has a section on infection: "when vancomycin and gentamycin are prescribed during the implant, the antibiotics will stay in the patient's system for 7 days without dialyzing out during their dialysis treatments.If a patient has a history of chronic infection, the nephrologist might consider keeping the patient on an antibiotic course until the bridging catheter is removed." additional considerations to reduce the risk of infection, especially during the bridging period, include applying antibiotic ointment to the bridging catheter exit site.Remove the bridging catheter as soon as possible once the hero graft is being cannula ted to decrease the risk of an infection related to the bridging catheter.During clinical trials, the only infections seen were during the bridging period (katzman, jvs 2009).All bridging catheters should be cultured upon explant.In the event that the catheter tip cultures are positive, treat the patient with appropriate antibiotics to decrease the risk of the hero graft becoming infected.Without culture results, the source of the infection and the relationship of the infection to the hero graft device in this patient cannot be determined.However, the surgeon speculated the infection was due to dialysis staff mishandling and it spreading to the hero graft due to the patient's non-compliance on antibiotics.Explant was required due to the location of the infection near the connector and as a precaution measure to prevent the infection from extending from the eptfe graft to the voc and into the patient's heart.A medical review of this event was performed.According to the information received, the patient developed a boil that required drainage and antibiotic treatment approximately 5 months following implant of the hero graft.The infection recurred approximately one month later, requiring additional drainage and antibiotic treatment.However, due to patient allergy, antibiotic treatment was not effective.The implanting surgeon stated there was a localized infection near the connector necessitating explant of the entire hero device.The patient was noted to be very obese with previous history of infections.The surgeon stated that in his opinion the infection was due to dialysis staff mishandling and patient non-compliance with antibiotic treatment.The surgeon described the area of infection as a pustule.He was concerned that the dialysis may have inappropriately accessed the graft, leading to pseudoaneurysm and infection of the surrounding tissues.The information received from the implanting surgeon is consistent with a soft tissue/skin infection surrounding the hero graft in a patient with a history of recurrent infections and poor medical compliance.The cause of the infection is unknown; however, compromised aseptic technique during dialysis access or post-operative wound infection are possible explanations.As the hero graft is sterilized using a validated sterilization method, it is unlikely that the graft was the cause of the reported event.The manufacturing records for lots 0001511, 0001625, and 0001808 were reviewed by quality and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Based on quality control's investigation of this complaint, there is no indication that the ncmrs, deviations, or corrective actions listed above would have any impact on the sterility of the hero arterial graft 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: 3836592
• MDR Text Key: 17296128
• Report Number: 3006945290-2014-00041
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2012

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
• Device Lot Number: 0001511, 0001625, OR 0001808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2012
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2014
• 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