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

Model Number HERO 1001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Hematoma (1884); Seroma (2069); Thrombosis (2100); Impaired Healing (2378); Pseudoaneurysm (2605)

Event Date 09/09/2011

Event Type  Injury  

Event Description

According to the publication, experience of hero dialysis graft placement in a challenging population, a total of 11 patients underwent 12 hero graft implants.All of the patients had cvod to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and av fistulasd or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), bacteremia (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abcess formation over graft." this medwatch is being submitted one of the bacteremia events.

Manufacturer Narrative

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

Manufacturer Narrative

According to the publication, "experience of hero dialysis graft placement in a challenging population," a total of 11 patients underwent 12 hero graft implants.All of the patients had cardiovascular occlusive disease (cvod) to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and arteriovenous [av] fistulas or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for re-intervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), bacteremia (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abscess formation over graft." this medwatch was submitted for one of the bacteremia events.Additional information was received from the surgeon.From the additional information it was determined this event occurred in patient 2.Patient 2 was a male who had a hero graft (hero 1001, lot 001184 and hero 1002, lot 0001186) implanted on (b)(6) 2010.The patient has had multiple complications including thrombosis, pseudoaneurysm, bacteremia, seroma, and hematoma.Bacteremia was identified on 8/2/2011 and the hero graft was cannulated during bacteremia.Blood culture results gram positive cocci however, urine culture results no growth.A second bacteremia incident occurred (b)(6) 2011 and the hero graft was not cannulated during.Blood culture results gram positive cocci.A third bacteremia incident occurred (b)(6) 2011 and the hero graft was cannulated during.Blood culture results gram positive cocci.Two seromas were identified in the patient on (b)(6) 2010 and (b)(6) 2011; both seromas were located near right upper extremity near location of arterial anastomosis.Three hematomas were identified on (b)(6) 2010, (b)(6) 2014 and (b)(6) 2015.The hematomas occurred in the right upper extremity around arterial end of graft, in the right upper extremity near arterial anastomosis but did not involve graft, and in the right upper extremity around distal third of graft segment.A mechanical thrombectomy and revision of the graft occurred on (b)(6) 2014 for thrombosis.Pseudoaneurysms were identified on (b)(6) 2014, (b)(6) 2015, during all three of which the hero was cannulated.Each event which occurred in patient 2 while a hero graft was implanted was investigated and separate medwatches were submitted for each.This medwatch is for the second bacteremia episode on (b)(6) 2011.The manufacturing records for lots hero 1001, lot 001184 and hero 1002, lot 0001186 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The ifu also lists infection and abnormal healing as potential complications.Infection is a known complication of prosthetic arteriovenous (av) grafts.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.Five local infections were reported in 3 patients and 5 bacteremia events were reported in 3 patients.Two patients had both local infections and bacteremia.The publication reported that 3 study patients had a history of bacteremia, but it is unclear if those patients were the same as those with the local infections and/or bacteremia.Additional information regarding local infection blood culture results reported "blood culture results no growth" for 4 cases, 1 case with "wound culture light growth gram negative bacilli", 1 case with "culture results gram positive bacilli and gram negative bacilli" and 3 cases with no culture results.Additional information regarding bacteremia blood culture results reported gram positive cocci in 4 cases and 1 case with gram negative bacilli.As previously stated, patient history of infection is unknown and the details on source of infection and bacteremia were not provided.It is also unclear how the patients with local infection and bacteremia were receiving dialysis, specifically if they had a bridging catheter.As stated in the hero ifu bridging catheters should be removed as soon as possible to decrease risk of infection related to the catheter.

Event Description

According to the publication, experience of hero dialysis graft placement in a challenging population, a total of 11 patients underwent 12 hero graft implants.All of the patients had cvod to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and av fistulas or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), bacteremia (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abcess formation over graft." this medwatch is being submitted one of the bacteremia events.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 4843927
• MDR Text Key: 5937171
• Report Number: 1063481-2015-00097
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• 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: 06/01/2015

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 1001
• Device Lot Number: 001184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• 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): Hospitalization; Required Intervention