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

Model Number HERO 1002

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Occlusion (1984); Sudden Cardiac Death (2510)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report, a graft was implanted on (b)(6) 2015 and explanted on (b)(6) 2015 due to infection.Additional information from the rep indicated the following responses by the surgeon: where was the infection? "appr.4cm after the anastomosis with the brachial artery in the ptfe part of the graft.What infection? "skin defect due to subsequent punctures and graft a vue." was a culture done? "yes, several.All showing the same result; no monoculture but positive for several skin bacteria." when where the first signs discovered? "(b)(6) 2015" has the patient been affected? "no sepsis occurred, however several bleedings from the affected part of the shunt took place." will we get a product returned? ", it has been send for culture to the lab." the complaint investigation will cover both hero 1001 and 1002 components but will be reported under hero 1001.

Manufacturer Narrative

According to the initial report, a graft was implanted on (b)(6) 2015 and explanted on (b)(6) 2015 due to infection.Corrected data: additional information indicated that the affected part of the graft was associated with the hero 1002 component, therefore the investigation is relegated to this component.The following correspondence between the rep and surgeon (indicated in italics) in reference to the reported events: where was the infection? "appr.4cm after the anastomosis with the brachial artery in the ptfe part of the graft." what infection? "skin defect due to subsequent punctures and graft a vue [on sight, visualization]." was a culture done? yes, several.All showing the same result; no monoculture but positive for several skin bacteria.When where the first signs discovered? (b)(6) 2015.Has the patient been affected? no sepsis occurred, however several bleedings from the affected part of the shunt took place.Will we get a product returned? no, it has been send for culture to the lab.Clarification was received from the surgeon: please clarify"bleedings from the affected part of the shunt" - bleeding from puncture places on de upper part of the forearm in the ptfe part of the graft.Are operative/progress notes available? "no, because of privacy matters.I can ask the patients permission to share this with you." current patient status? "see last question.Doing well." additional information from the surgeon indicated the results from the explanted hero graft and the following information: culture results: proximal part of the graftà multiple bacteria were cultured conform normal skin commensal bacterial flora (was expected since the prosthesis was visible in the skin-defect.Infection was due to a skin defect as a result of multiple punctures during dialysis en 2 times pta due to occlusion of the graft.Patient is well, a thoraxloopshunt is planned.The manufacturing records for lot h14av008 was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was implanted with a hero graft on (b)(6) 2015.On (b)(6) 2014 the patient had an infection that was approximately cm after the anastomosis with the brachial artery in the ptfe part of the graft.The infection was described as "skin defect due to subsequent punctures and graft a vue [on sight, visualization]." there was no reported sepsis.However, bleeding was reported from the graft puncture sites.There were multiple cultures done which showed the same result: "no monoculture but positive for several skin bacteria." the hero graft was explanted on (b)(6) 2015.The hero graft was sent for culture and the results were as follows: "proximal part of the graft multiple bacteria were cultured conform normal skin commensal bacterial flora (was expected since the prosthesis was visible in the skin-defect." at this point the source of the infection was again identified as "skin defect as a result of multiple puncture during dialysis" and the surgeon also noted that the patient had a history of two percutaneous transluminal angioplasties (pta) due to occlusion of the graft.The hero graft ifu lists infection as a potential complication.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.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 pta surgical site infection or infection related to cannulation, as was the case in this patient.The vascular surgeon noted that the patient had a history of two ptas due to graft occlusion.He did not provide additional information on the interventions, including when they occurred.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.

Event Description

According to the initial report, a graft was implanted on (b)(6) 2015 and explanted on (b)(6) 2015 due to infection.Additional information from the rep indicated the following responses by the surgeon: where was the infection? "appr.4cm after the anastomosis with the brachial artery in the ptfe part of the graft.What infection? "skin defect due to subsequent punctures and graft a vue." was a culture done? "yes, several.All showing the same result; no monoculture but positive for several skin bacteria." when where the first signs discovered? "(b)(6) 2015" has the patient been affected? "no sepsis occurred, however several bleedings from the affected part of the shunt took place." will we get a product returned? "it has been send for culture to the lab." the complaint investigation will cover both hero 1001 and 1002 components but will be reported under hero 1001.

Manufacturer Narrative

According to the initial report, a hero patient "(002-006) was implanted with a graft on (b)(6) 2015.The coordinator reported today that the patient "expired prior to his one month visit".Date of death was (b)(6) 2015, ruled cardiac arrest." follow-up case report forms and medical/progress notes for the patient death on (b)(6) 2015 were submitted on 11/05/2015.The medical notes stated "(b)(6) male presenting to the ed [emergency department] for witnessed cardiac arrest at home.The call was placed at 11:04am.No cpr was initiated prior to ems arrival.Per medics, 3 epi and 50 meq/ml of bicarb were administered in route.There is an io [intraosseous infusion] in right tibia and an et [endotracheal tube] tube in place.According to family, pt missed home dialysis 2 days ago due to av graft placement.Dialysis nurse was at the house today when pt arrested.Hpi [history of present illness] limited secondary to unresponsiveness." the physician indicated "pt treated according to acls [advanced cardiac life support] protocols.No return of spontaneous circulation despite prolonged efforts.Further intervention at this point likely to be futile.Case called." the following patient medical history was recorded in the medical notes: end stage renal disease on home dialysis (6 days/week), gout, ppd [purified protein derivative] positive treated [tuberculosis test positive], hypertension, morbidly obese, history of staphylococcus, thyroid disease, decreased exercise tolerance, infection/sepsis in june 2015, and current smoker.The manufacturing records for lots h14vc048 and h15av002 were reviewed and met all specifications per the device master record.This hero registry patient was implanted with a hero graft on (b)(6) 2015.The graft was implanted with a brachial arterial anastomosis and the venous access point was an internal jugular vein.The graft was implanted with the arterial graft component (agc) anastomosed to a flixene vascular graft.The first date of cannulation is not documented, although the patient died three days after implant.The patient's pre-existing medical conditions include the following: multiple failed attempts at dialysis access, gout, ppd positive (treated), hypertension (htn), history of infection (staphylococcus) with prior accesses (including fistula), thyroid disease, morbid obesity, and end stage renal disease (esrd).On (b)(6) 2015 the patient presented with cardiac arrest and was unable to be resuscitated.The family reported that the patient had missed home hemodialysis two days prior "due to av graft placement." the final diagnosis on the discharge summary was cardiac arrest and esrd.It should be noted that the patient was documented to have no adverse events during the hero graft implant period.The reason why the patient missed a dialysis session is unknown; the patient had a femoral catheter placed during the hero graft implant to serve as a bridging catheter.The reason the patient went into cardiac arrest was not documented.There was no documented relationship between the hero graft and the patient's death.The patient had a procedure modification to include flixene graft attached to the arterial graft component.The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with a flixene graft have not been evaluated by cryolife.

Event Description

According to the initial report, a hero patient "(002-006) was implanted with a graft on (b)(6) 2015.The coordinator reported today that the patient "expired prior to his one month visit".Date of death was (b)(6) 2015, ruled cardiac arrest." the scope of the investigation will include both hero 1001 and 1002 components, but will be reported under hero 1001.

Manufacturer Narrative

Correction: please disregard followup 2 sent on 02/03/2016.It was submitted in error under 1063481-2015-00336.According to the initial report, a graft was implanted on (b)(6) 2015 and explanted on 10/05/2015 due to infection.Corrected data: additional information indicated that the affected part of the graft was associated with the hero 1002 component, therefore the investigation is relegated to this component.The following correspondence between the rep and surgeon (indicated in italics) in reference to the reported events: -where was the infection? "appr.4cm after the anastomosis with the brachial artery in the ptfe part of the graft." -what infection? "skin defect due to subsequent punctures and graft a vue [on sight, visualization]" -was a culture done? yes, several.All showing the same result; no monoculture but positive for several skin bacteria.-when where the first signs discovered? (b)(6) 2015.-has the patient been affected? no sepsis occurred, however several bleedings from the affected part of the shunt took place.-will we get a product returned? no, it has been send for culture to the lab.Clarification was received from the surgeon: -please clarify"bleedings from the affected part of the shunt" - bleeding from puncture places on de upper part of the forearm in the ptfe part of the graft.-are operative/progress notes available? "no, because of privacy matters.I can ask the patients permission to share this with you." -current patient status? "see last question.Doing well." additional information from the surgeon indicated the results from the explanted hero graft and the following information: culture results: proximal part of the graftà multiple bacteria were cultured conform normal skin commensal bacterial flora (was expected since the prosthesis was visible in the skin-defect.Infection was due to a skin defect as a result of multiple punctures during dialysis en 2 times pta due to occlusion of the graft.Patient is well, a thoraxloopshunt is planned.The manufacturing records for lot h14av008 was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was implanted with a hero graft on (b)(6) 2015.On (b)(6) 2014 the patient had an infection that was approximately cm after the anastomosis with the brachial artery in the ptfe part of the graft.The infection was described as "skin defect due to subsequent punctures and graft a vue [on sight, visualization]." there was no reported sepsis.However, bleeding was reported from the graft puncture sites.There were multiple cultures done which showed the same result: "no monoculture but positive for several skin bacteria." the hero graft was explanted on (b)(6) 2015.The hero graft was sent for culture and the results were as follows: "proximal part of the graft multiple bacteria were cultured conform normal skin commensal bacterial flora (was expected since the prosthesis was visible in the skin-defect." at this point the source of the infection was again identified as "skin defect as a result of multiple puncture during dialysis" and the surgeon also noted that the patient had a history of two percutaneous transluminal angioplasties (pta) due to occlusion of the graft.The hero graft ifu lists infection as a potential complication.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.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 pta surgical site infection or infection related to cannulation, as was the case in this patient.The vascular surgeon noted that the patient had a history of two ptas due to graft occlusion.He did not provide additional information on the interventions, including when they occurred.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.

Event Description

According to the initial report, a graft was implanted on (b)(6) 2015 and explanted on (b)(6) 2015 due to infection.Additional information from the rep indicated the following responses by the surgeon: where was the infection? "appr.4cm after the anastomosis with the brachial artery in the ptfe part of the graft.What infection? "skin defect due to subsequent punctures and graft a vue." was a culture done? "yes, several.All showing the same result; no monoculture but positive for several skin bacteria." when where the first signs discovered? "(b)(6) 2015".Has the patient been affected? "no sepsis occurred, however several bleedings from the affected part of the shunt took place." will we get a product returned? ", it has been send for culture to the lab." the complaint investigation will cover both hero 1001 and 1002 components but will be reported under hero 1001.

• 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: 5201683
• MDR Text Key: 30412054
• Report Number: 1063481-2015-00336
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/07/2015

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 1002
• Device Lot Number: H14AV008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2016; 02/03/2016; 02/03/2016
• 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): Death; Hospitalization; Other
• Patient Age: 55 YR