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

Model Number HERO 1001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Thrombosis (2100); Pseudoaneurysm (2605)

Event Date 03/21/2014

Event Type  Injury  

Manufacturer Narrative

Note: this mdr is being re-sent to mark g7 as initial.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 covd 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 greater than 14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention of 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), 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." additional information was received from the surgeon which showed that patient 8 had experienced a local infection event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 8 was a male who had a hero graft (lot numbers unk) implanted on (b)(6) 2010 and was explanted on (b)(6) 2014 due to pseudoaneurysm, hematomas and infection.He had a second hero graft (lot numbers unk) implanted on (b)(6)2014.The patient had a mechanical thrombectomy and revision of graft for thrombosis on (b)(6) 2010.A local infection was identified on (b)(6) 2014.The hero graft was not being cannulated during infection and there are no culture results.Three pseudoaneurysms were noted, two in the original hero graft and one in the subsequent hero graft.The pseudoaneurysms were identified on (b)(6) 2010, (b)(6) 2013 and (b)(6) 2014; the hero graft was being cannulated during the pseudoaneurysm in all three cases.Bacteremia was confirmed in the patient on (b)(6) 2014 and the graft was not cannulated during the bacteremia.Blood culture result showed gram negative bacilli.Two seromas were identified on (b)(6) 2014 and (b)(6) 2015; however, location of seromas is unknown.A total of five hematomas are listed occurring in both hero grafts.A hematoma was identified on (b)(6) 2010 occurring in the right arm proximal to mid upper arm and the hero was being cannulated during the hematoma.The second hematoma was identified on (b)(6) 2013 occurring in the right mid upper arm, and the hero graf was cannulated during the hematoma.The third hematoma was identified on (b)(6) 2014 occurring in the right arm distal upper arm and right arm extending from proximal upper arm to the shoulder and the graft was not cannulated during the hematoma.The fourth and fifth hematomas were identified on (b)(6) 2014 occurring in right arm proximal to mid upper arm.Each event which occurred to patient 8 was investigated and a separate medwatch filed.This medwatch is filed fo the local infection which occurred on (b)(6) 2015.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 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.The root cause for the reported event is unknown; however, all complications noted in the complaint are known potential complication of the hero graft.The ifu lists the following potential complications with the use of the hero graft: seroma, infection, vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, pseudoaneurysm, hematoma, and abnormal healing.The hero graft is unlikely to be the direct source of the infection as the product undergoes a validated terminal sterilization process.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risks.

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 covd 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 greater than 14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention of 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), 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." additional information was received from the surgeon which showed that patient 8 had experienced a local infection event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 8 was a male who had a hero graft (lot numbers unk) implanted on (b)(6) 2010 and was explanted on (b)(6) 2014 due to pseudoaneurysm, hematomas and infection.He had a second hero graft (lot numbers unk) implanted on (b)(6) 2014.The patient had a mechanical thrombectomy and revision of graft for thrombosis on (b)(6) 2010.A local infection was identified on (b)(6) 2014.The hero graft was not being cannulated during infection and there are no culture results.Three pseudoaneurysms were noted, two in the original hero graft and one in the subsequent hero graft.The pseudoaneurysms were identified on (b)(6) 2010, (b)(6) 2013 and (b)(6) 2014; the hero graft was being cannulated during the pseudoaneurysm in all three cases.Bacteremia was confirmed in the patient on (b)(6) 2014 and the graft was not cannulated during the bacteremia.Blood culture result showed gram negative bacilli.Two seromas were identified on (b)(6) 2014 and (b)(6) 2015; however, location of seromas is unknown.A total of five hematomas are listed occurring in both hero grafts.A hematoma was identified on (b)(6) 2010 occurring in the right arm proximal to mid upper arm and the hero was being cannulated during the hematoma.The second hematoma was identified on (b)(6) 2013 occurring in the right mid upper arm, and the hero graf was cannulated during the hematoma.The third hematoma was identified on (b)(6) 2014 occurring in the right arm distal upper arm and right arm extending from proximal upper arm to the shoulder and the graft was not cannulated during the hematoma.The fourth and fifth hematomas were identified on (b)(6) 2014 occurring in right arm proximal to mid upper arm.Each event which occurred to patient 8 was investigated and a separate medwatch filed.This medwatch is filed fo the local infection which occurred on (b)(6) 2015.

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 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), 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." additional information was received from the surgeon which showed that patient 8 had experienced a local infection event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 8 was a male who had a hero graft (lot numbers unknown) implanted on (b)(6) 2010 and was explanted on (b)(6) 2014 due to pseudoaneurysm, hematomas and infection.He had a second hero graft (lot numbers unknown) implanted on (b)(6) 2014.The patient had a mechanical thrombectomy and revision of graft for thrombosis on (b)(6) 2010.A local infection was identified on (b)(6) 2014.The hero graft was not being cannulated during infection and there are no culture results.Three pseudoaneurysms were noted, two in the original hero graft and one in the subsequent hero graft.The pseudoaneurysms were identified on (b)(6) 2010, (b)(6) 2013 and (b)(6) 2014; the hero graft was being cannulated during the pseudoaneurysm in all three cases.Bacteremia was confirmed in the patient on (b)(6) 2014 and the graft was not cannulated during the bacteremia.Blood culture result showed gram negative bacilli.Two seromas were identified on (b)(6) 2014 and (b)(6) 2015; however, location of seromas is unknown.A total of five hematomas are listed occurring in both hero grafts.A hematoma was identified on (b)(6) 2010 occurring in the right arm proximal to mid upper arm and the hero was being cannulated during the hematoma.The second hematoma was identified on (b)(6) 2013 occurring in the right mid upper arm and the hero graft was cannulated during the hematoma.The third hematoma was identified on (b)(6) 2014 occurring in the right arm distal upper arm and right arm extending from proximal upper arm to the shoulder and the graft was not cannulated during the hematoma.The fourth and fifth hematomas were identified on (b)(6) 2014 occurring in right arm proximal to mid upper arm.Each event which occurred in patient 8 was investigated and a separate medwatch filed.This medwatch is filed for the local infection which occurred on (b)(6) 2015.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.The root cause for the reported event is unknown; however, all complications noted in the complaint are known potential complication of the hero graft.The ifu lists the following potential complications with the use of the hero graft: seroma, infection, vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, pseudoaneurysm, hematoma, and abnormal healing.The hero graft is unlikely to be the direct source of the infection as the product undergoes a validated terminal sterilization process.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

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), 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." additional information was received from the surgeon which showed that patient 8 had experienced a local infection event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 8 was a male who had a hero graft (lot numbers unknown) implanted on (b)(6) 2010 and was explanted on (b)(6) 2014 due to pseudoaneurysm, hematomas and infection.He had a second hero graft (lot numbers unknown) implanted on (b)(6) 2014.The patient had a mechanical thrombectomy and revision of graft for thrombosis on (b)(6) 2010.A local infection was identified on (b)(6) 2014.The hero graft was not being cannulated during infection and there are no culture results.Three pseudoaneurysms were noted, two in the original hero graft and one in the subsequent hero graft.The pseudoaneurysms were identified on (b)(6) 2010, (b)(6) 2013 and (b)(6) 2014; the hero graft was being cannulated during the pseudoaneurysm in all three cases.Bacteremia was confirmed in the patient on (b)(6) 2014 and the graft was not cannulated during the bacteremia.Blood culture result showed gram negative bacilli.Two seromas were identified on (b)(6) 2014 and (b)(6) 2015; however, location of seromas is unknown.A total of five hematomas are listed occurring in both hero grafts.A hematoma was identified on (b)(6) 2010 occurring in the right arm proximal to mid upper arm and the hero was being cannulated during the hematoma.The second hematoma was identified on (b)(6) 2013 occurring in the right mid upper arm and the hero graft was cannulated during the hematoma.The third hematoma was identified on (b)(6) 2014 occurring in the right arm distal upper arm and right arm extending from proximal upper arm to the shoulder and the graft was not cannulated during the hematoma.The fourth and fifth hematomas were identified on (b)(6) 2014 occurring in right arm proximal to mid upper arm.Each event which occurred in patient 8 was investigated and a separate medwatch filed.This medwatch is filed for the local infection which occurred on (b)(6) 2015.

• 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: 4957718
• MDR Text Key: 82658672
• Report Number: 1063481-2015-00131
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• 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: 07/16/2015
• 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