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

Model Number HERO 1001

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

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Thrombosis (2100); Impaired Healing (2378); Pseudoaneurysm (2605)

Event Date 04/24/2014

Event Type  Injury  

Manufacturer Narrative

Note: this mdr is being re-sent to mark type of reports as initial.Thrombosis is the most common cause of vascular access dysfunction and is listed as a potential complication in the hero instructions for use (ifu).Eight thrombosis events (in the entire patient population) were documented in 7 patients.Four of the events were treated with thrombectomy (mechanical and open) and graft revision; two events were treated with thrombectomy (mechanical and open) alone.A thrombectomy was an appropriate course of action to restore flow; however the hero ifu states that mechanical/ rotational devices are contraindicated in the venous outflow component (voc) and connector as internal damage may occur to these components.It is unclear if the mechanical thrombectomies were performed in the voc or the arterial graft component (agc).Two events were documented as "no reintervention noted".Patient history of multiple failed accesses and various forms of central venous stenosis may have an impact on the risk of thrombosis but without specific case details, the degree of patient history involvement is unknown.Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The operative notes for hero implants and the interventions were not provided and the specific relationship between the hero graft and the observed thrombectomies cannot be assessed at this time.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 pts underwent 12 hero graft implants.All of the pt had cvod to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these pts had multiple vascular accesses (catheters and av fistula or grafts) placed prior to the hero, with a minimum of 2 and a maximum of <14.Only 3 pts 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 9 had experienced a thrombosis event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 9 was a male who had a hero graft (hero 1001, lot unknown and hero 1002, lot 0001326) implanted on (b)(6) 2010 and explanted on (b)(6) 2011.A subsequent hero graft was implanted on (b)(6) 2013 (hero 1001, lot 001873 and hero 1002, lot unknown) and explanted (b)(6) 2013.The patients third hero graft (lot numbers unknown) was implanted on (b)(6) 2014 and explanted (b)(6) 2015.Two revisions were performed for thrombosis.On (b)(6) 2014 an open thrombectomy and revision of graft was performed and on (b)(6) 2014 a mechanical thrombectomy was performed.A local infection was identified on (b)(6) 2013; the graft was not cannulated during the infection and blood culture results no growth, other culture results gram positive bacilli and gram negative bacilli.A second local infection was identified on (b)(6) 2011 and the graft was not cannulated during the local infection.Blood cultures showed no growth.A third local infection was identified on (b)(6) 2014; the graft was not cannulated during the infection and blood cultures showed no growth.Bacteremia was confirmed on (b)(6) 2013 the hero graft was not cannulated during bacteremia episode.Blood culture result showed gram positive cocci.Each event which occurred in patient 9 was investigated and a separate medwatch filed.This medwatch is filed for the thrombosis which occurred on (b)(6) 2014.

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 9 had experienced a thrombosis event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 9 was a male who had a hero graft (hero 1001, lot unknown and hero 1002, lot 0001326) implanted on (b)(6) 2010 and explanted on (b)(6) 2011.A subsequent hero graft was implanted on (b)(6) 2013 (hero 1001, lot 001873 and hero 1002, lot unknown) and explanted (b)(6) 2013.The patients third hero graft (lot numbers unknown) was implanted on (b)(6) 2014 and explanted (b)(6) 2015.Two revisions were performed for thrombosis.On (b)(6) 2014 an open thrombectomy and revision of graft was performed and on (b)(6) 2014 a mechanical thrombectomy was performed.A local infection was identified on (b)(6) 2013; the graft was not cannulated during the infection and blood culture results no growth, other culture results gram positive bacilli and gram negative bacilli.A second local infection was identified on (b)(6) 2011 and the graft was not cannulated during the local infection.Blood cultures showed no growth.A third local infection was identified on (b)(6) 2014; the graft was not cannulated during the infection and blood cultures showed no growth.Bacteremia was confirmed on (b)(6) 2013 the hero graft was not cannulated during bacteremia episode.Blood culture result showed gram positive cocci.Each event which occurred in patient 9 was investigated and a separate medwatch filed.This medwatch is filed for the thrombosis which occurred on (b)(6) 2014.Thrombosis is the most common cause of vascular access dysfunction and is listed as a potential complication in the hero instructions for use (ifu).Eight thrombosis events (in the entire patient population) were documented in 7 patients.Four of the events were treated with thrombectomy (mechanical and open) and graft revision; two events were treated with thrombectomy (mechanical and open) alone.A thrombectomy was an appropriate course of action to restore flow; however the hero ifu states that mechanical/ rotational devices are contraindicated in the venous outflow component (voc) and connector as internal damage may occur to these components.It is unclear if the mechanical thrombectomies were performed in the voc or the arterial graft component (agc).Two events were documented as "no reintervention noted".Patient history of multiple failed accesses and various forms of central venous stenosis may have an impact on the risk of thrombosis but without specific case details, the degree of patient history involvement is unknown.Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The operative notes for hero implants and the interventions were not provided and the specific relationship between the hero graft and the observed thrombectomies cannot be assessed at this time.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 9 had experienced a thrombosis event after the original publication was printed.Hero 1001 and hero 1002 were investigated.Patient 9 was a male who had a hero graft (hero 1001, lot unknown and hero 1002, lot 0001326) implanted on (b)(6) 2010 and explanted on (b)(6) 2011.A subsequent hero graft was implanted on (b)(6) 2013 (hero 1001, lot 001873 and hero 1002, lot unknown) and explanted (b)(6) 2013.The patients third hero graft (lot numbers unknown) was implanted on (b)(6) 2014 and explanted (b)(6) 2015.Two revisions were performed for thrombosis.On (b)(6) 2014 an open thrombectomy and revision of graft was performed and on (b)(6) 2014 a mechanical thrombectomy was performed.A local infection was identified on (b)(6) 2013; the graft was not cannulated during the infection and blood culture results no growth, other culture results gram positive bacilli and gram negative bacilli.A second local infection was identified on (b)(6) 2011 and the graft was not cannulated during the local infection.Blood cultures showed no growth.A third local infection was identified on (b)(6) 2014; the graft was not cannulated during the infection and blood cultures showed no growth.Bacteremia was confirmed on (b)(6) 2013 the hero graft was not cannulated during bacteremia episode.Blood culture result showed gram positive cocci.Each event which occurred in patient 9 was investigated and a separate medwatch filed.This medwatch is filed for the thrombosis which occurred on (b)(6) 2014.

• 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: 4956673
• MDR Text Key: 82675693
• Report Number: 1063481-2015-00129
• 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

• 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
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: 07/16/2015
• 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