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

Model Number HERO 1001

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 07/10/2015

Event Type  Injury  

Manufacturer Narrative

Note: this mdr is being re-sent to mark g7 as initial.The manufacturing records for lots hero 1001, lot 001184 and hero 1002, lot 0001186 were reviewed by quality assurance/quality control (qa/qc), 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 pseudoaneurysm and seromas as potential vascular graft and catheter complications.Seven pseudoaneurysm cases were reported in 3 patients.At the time of pseudoaneurysm identification, grafts were cannulated.As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.Details of dialysis sessions were unknown and compliance with rotation cannot be confirmed.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 2 had experienced a pseudoaneurysm after the original publication was printed.Hero 1001 and hero 1002 were investigated.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 (b)(6) 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, and (b)(6) 2015, during all three of which the hero was cannulated.Each event which occurred in patient 2 was investigated and a separate medwatch filed.This medwatch is filed for the pseudoaneurysm 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 greater than 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 2 had experienced a pseudoaneurysm after the original publication was printed.Hero 1001 and hero 1002 were investigated.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 (b)(6) 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, and (b)(6) 2015, during all three of which the hero was cannulated.Each event which occurred in patient 2 was investigated and a separate medwatch filed.This medwatch is filed for the pseudoaneurysm which occurred on (b)(6) 2015.The manufacturing records for lots hero 1001, lot 001184 and hero 1002, lot 0001186 were reviewed by quality assurance/quality control (qa/qc), 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 pseudoaneurysm and seromas as potential vascular graft and catheter complications.Seven pseudoaneurysm cases were reported in 3 patients.At the time of pseudoaneurysm identification, grafts were cannulated.As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.Details of dialysis sessions were unknown and compliance with rotation cannot be confirmed.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.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

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 greater than 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 2 had experienced a pseudoaneurysm after the original publication was printed.Hero 1001 and hero 1002 were investigated.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 (b)(6) 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, and (b)(6) 2015, during all three of which the hero was cannulated.Each event which occurred in patient 2 was investigated and a separate medwatch filed.This medwatch is filed for the pseudoaneurysm 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: 4959633
• MDR Text Key: 82886839
• Report Number: 1063481-2015-00138
• 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: 08/03/2015
• 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: 0001184
• 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; Disability