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

Model Number HERO 1001 AND HERO 1002

Device Problem Complete Blockage (1094)

Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis (2100); Cardiogenic Shock (2262)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

According to the report, "hero implant with arterial connection in sulcus deltoideeopectoralis in (b)(6) 2014.In (b)(6) 2015 stenosis of the shunt vena and the hero graft.Thrombectomy and transposition to vena basilica.(b)(6) 2015 pulmonary embolism with cardiogenic shock.(b)(6) 2015 bleeding shunt at ulcus lower arm.Hero was suspended, accuseal shunt loop (prox.A.Rad.To v.Basilica)." multiple contact attempts were made to obtain additional information including, date of implant and lot number, the date of the occlusion and stenosis, the date of the thrombectomy, the transposition to vena basilica, dates of pulmonary embolism and cardiogenic shock and if these events were related to the hero, the bleeding in (b)(6) 2015, information relating to the suspension of the hero, patient impact, and any other patient information available.The following additional information was received: the lot numbers h14av015 and h14vc041, there was no device migration, according to dr.(b)(6) there is no evidence that the hero graft is related to the pulmonary embolism or cardiogenic shock, the bleeding in (b)(6) 2015 was due to the arterial graft component (agc) weeping, the venous outflow component (voc) was explanted, and there was no other patient information available.The manufacturing records for lots h14av015 and h14vc041 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.The patient was implanted with a hero graft on (b)(6) 2014; the graft was implanted "with arterial connection in sulcus deltoideeopectoralis." on (b)(6) 2015 the patient had a stenosis involving both the voc and the agc.The patient was treated with a "thrombectomy and transposition to vena basilica." partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).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 following information is not available for consideration in any reported event: patient medical history, implant/intervention notes, and dialysis information.The specific relationship between the thrombosis/occlusion events and the hero graft was not documented and cannot be determined with the information provided.The patient had a fulminant pulmonary embolism (pe) with cardiogenic shock in (b)(6) of 2015 (the specific date is unknown).According to the surgeon, "there is no evidence to suggest that the hero is related to the pulmonary embolism and cardiogenic shock." the hero graft ifu lists embolism as a potential intraoperative and post-operative complication.As previously stated, no additional information was provided.The specific relationship between the pe event with associated cardiogenic shock and the hero graft was not documented and cannot be assessed with the information provided; the surgeon did state that the hero graft did not have documented involvement in these events.The patient had an emergency presentation of "bleeding from the shunt above ulcus on the lower arm[?]" in (b)(6) of 2015 (the specific date is unknown).The treatment was described as follows: "operative revision with lifting of shunt at local infection, temporary coverage with mesh-graft after vac [vacuum assisted closure?], placed half-loop shunt on the left side (proximal radial artery to basilica vein) with gore-accuseal-prosthesis." the hero graft ifu lists bleeding and infection 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 procedures.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site or cannulation site infection.The infection was described as "local" but no additional information, including culture results, were reported.A relationship between the hero graft and the infection and the bleeding cannot be determined with the provided information.The root cause for the events described, stenosis, pulmonary embolism, cardiogenis shock, bleeding, and infection, cannot be determined, however all are listed in the ifu as potential known complications.The ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature, infection, bleeding, and embolism.The ifu states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft," "verify the systolic blood pressure is at least 100mmhg.As with conventional grafts hero graft may occlude in patients with systemic low blood pressure or sever hypotension following fluid removal post dialysis," "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication," and "implantation of the hero graft is contraindicated if: the patient has a topical or subcutaneous infection associated with the implantation site; the patient has known or suspected systemic infection, bacteremia or septicemia.Obtain screening blood cultures to rule out asymptomatic bacteremia prior to hero graft implant for any patient dialyzing on a catheter; treat patient with antibiotics per culture outcome and ensure infection is resolved prior to hero graft implant procedure." this event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the report, "hero implant with arterial connection in sulcus deltoidpectoralis in (b)(6) 2014.In (b)(6) 2015 stenosis of the shunt vena and the hero graft - thrombectomy and transposition to vena basilica.(b)(6) 2015 pulmonary embolism with cardiogenic shock.(b)(6) 2015 bleeding shunt at ulcus lower arm - hero was suspended - accuseal shunt loop (prox.A rad.To v.Basilica).".

Manufacturer Narrative

According to the report, "hero implant with arterial connection in sulcus deltoideeopectoralis in (b)(6) 2014.In (b)(6) 2015 stenosis of the shunt vena and the hero graft.Thrombectomy and transposition to vena basilica.(b)(6) 2015 pulmonary embolism with cardiogenic shock.(b)(6) 2015 bleeding shunt at ulcus lower arm.Hero was suspended, accuseal shunt loop (prox.A.Rad.To v.Basilica)." multiple contact attempts were made to obtain additional information including, date of implant and lot number, the date of the occlusion and stenosis, the date of the thrombectomy, the transposition to vena basilica, dates of pulmonary embolism and cardiogenic shock and if these events were related to the hero, the bleeding in (b)(6) 2015, information relating to the suspension of the hero, patient impact, and any other patient information available.The following additional information was received: the lot numbers h14av015 and h14vc041, there was no device migration, according to dr.(b)(6) there is no evidence that the hero graft is related to the pulmonary embolism or cardiogenic shock, the bleeding in (b)(6) 2015 was due to the arterial graft component (agc) weeping, the venous outflow component (voc) was explanted, and there was no other patient information available.The manufacturing records for lots h14av015 and h14vc041 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.The patient was implanted with a hero graft on (b)(6) 2014; the graft was implanted "with arterial connection in sulcus deltoideeopectoralis." on (b)(6) 2015 the patient had a stenosis involving both the voc and the agc.The patient was treated with a "thrombectomy and transposition to vena basilica." partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).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 following information is not available for consideration in any reported event: patient medical history, implant/intervention notes, and dialysis information.The specific relationship between the thrombosis/occlusion events and the hero graft was not documented and cannot be determined with the information provided.The patient had a fulminant pulmonary embolism (pe) with cardiogenic shock in (b)(6) of 2015 (the specific date is unknown).According to the surgeon, "there is no evidence to suggest that the hero is related to the pulmonary embolism and cardiogenic shock." the hero graft ifu lists embolism as a potential intraoperative and post-operative complication.As previously stated, no additional information was provided.The specific relationship between the pe event with associated cardiogenic shock and the hero graft was not documented and cannot be assessed with the information provided; the surgeon did state that the hero graft did not have documented involvement in these events.The patient had an emergency presentation of "bleeding from the shunt above ulcus on the lower arm[?]" in (b)(6) of 2015 (the specific date is unknown).The treatment was described as follows: "operative revision with lifting of shunt at local infection, temporary coverage with mesh-graft after vac [vacuum assisted closure?], placed half-loop shunt on the left side (proximal radial artery to basilica vein) with gore-accuseal-prosthesis." the hero graft ifu lists bleeding and infection 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 procedures.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site or cannulation site infection.The infection was described as "local" but no additional information, including culture results, were reported.A relationship between the hero graft and the infection and the bleeding cannot be determined with the provided information.The root cause for the events described, stenosis, pulmonary embolism, cardiogenis shock, bleeding, and infection, cannot be determined, however all are listed in the ifu as potential known complications.The ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature, infection, bleeding, and embolism.The ifu states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft," "verify the systolic blood pressure is at least 100mmhg.As with conventional grafts hero graft may occlude in patients with systemic low blood pressure or sever hypotension following fluid removal post dialysis," "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication," and "implantation of the hero graft is contraindicated if: the patient has a topical or subcutaneous infection associated with the implantation site; the patient has known or suspected systemic infection, bacteremia or septicemia.Obtain screening blood cultures to rule out asymptomatic bacteremia prior to hero graft implant for any patient dialyzing on a catheter; treat patient with antibiotics per culture outcome and ensure infection is resolved prior to hero graft implant procedure." this event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the report, "hero implant with arterial connection in sulcus deltoidpectoralis in (b)(6) 2014.In (b)(6) 2015 stenosis of the shunt vena and the hero graft - thrombectomy and transposition to vena basilica.(b)(6) 2015 pulmonary embolism with cardiogenic shock.(b)(6) 2015 bleeding shunt at ulcus lower arm - hero was suspended - accuseal shunt loop (prox.A rad.To v.Basilica).".

Manufacturer Narrative

According to the report, "hero implant with arterial connection in sulcus deltoidpectoralis in (b)(6) 2014 - in (b)(6) 2015 stenosis of the shunt vena and the hero graft - thrombectomy and transposition to vena basilica - (b)(6) 2015 pulmonary embolism with cardiogenic shock - (b)(6) 2015 bleeding shunt at ulcus lower arm - hero was suspended - accuseal shunt loop (prox.A rad.To v.Basilica)." the following additional information was the only information relevant to the reported event."[male] patient (b)(6) years old, hero implantation (b)(6) 2014, (b)(6) 2015 fulminant lung emboli with cardiogenic shock - cause?, (b)(6) 2015 emergency presentation with bleeding from the shunt above ulcus on the lower arm, operative revision with lifting of the shunt at local infection, temporary coverage with mesh-graft after vac [vacuum assisted closure?], placed half-loop shunt on the left side (proximal radial artery to basilica vein) with gore-accuseal-prosthesis (can be immediately cannulated)." a review was performed of the corrected information.The patient was implanted with a hero graft in (b)(6) 2014.The patient had a fulminant pulmonary embolism (pe) with cardiogenic shock in (b)(6) 2015 (the specific date is unknown).The hero graft ifu lists embolism as a potential intraoperative and post-operative complication; table 2 of the ifu shows rates of (b)(6) for (b)(6).The following information is not available for consideration in any reported event: patient medical history, implant/intervention notes, and dialysis information.The specific relationship between the (b)(6) event with associated cardiogenic shock and the hero graft was not documented and cannot be assessed with the information provided; the surgeon did state that the hero graft did not have documented involvement in these events.The patient had an emergency presentation of "bleeding from the shunt above ulcus on the lower arm." in (b)(6) 2015 (the specific date is unknown).The treatment was described as follows: "operative revision with lifting of shunt at local infection, temporary coverage with mesh-graft after vac [vacuum assisted closure?], placed half-loop shunt on the left side (proximal radial artery to basilica vein) with gore-accuseal-prosthesis." the hero graft ifu lists bleeding and infection 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 procedures.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's (b)(6) history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site or cannulation site infection.The infection was described as "local" but no additional information, including culture results, were reported.A relationship between the hero graft and the infection and the bleeding cannot be determined with the provided information.The root cause for the events described, pulmonary embolism, cardiogenic shock, bleeding, and infection, cannot be determined, however all are listed in the ifu as potential known complications.

Event Description

According to the report, "hero implant with arterial connection in sulcus deltoidpectoralis in (b)(6) 2014 - in (b)(6) 2015 stenosis of the shunt vena and the hero graft - thrombectomy and transposition to vena basilica - (b)(6) 2015 pulmonary embolism with cardiogenic shock - (b)(6) 2015 bleeding shunt at ulcus lower arm - hero was suspended - accuseal shunt loop (prox.A rad.To v.Basilica).".

• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5392552
• MDR Text Key: 83878779
• Report Number: 1063481-2015-00352
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/19/2016
• Device Model Number: HERO 1001 AND HERO 1002
• Device Lot Number: H14AV015; H14VC041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• 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): Other
• Patient Age: 48 YR