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

Model Number HERO 1001

Device Problems Complete Blockage (1094); Torn Material (3024)

Patient Problems Calcium Deposits/Calcification (1758); Sepsis (2067); Thrombosis (2100); Thrombus (2101)

Event Type  Injury  

Event Description

According to the notification form, "(b)(6).Right lower limb, using flixene.Required 1 declot at 2 months.Patient rip 4 months post op secondary to calciphylaxis related to needling the graft.Extreme end stage access with previous calciphylaxis on abdominal wall.Pre hero, k+ - 7.8 and multiple groin line sepsis.Line removed 48 hours post implant".

Manufacturer Narrative

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

Manufacturer Narrative

According to the notification form, "(b)(6) female.Right lower limb, using flixene.Required 1 declot at 2 months.Patient rip 4 months post op secondary to calciphylaxis related to needling the graft.Extreme end stage access with previous calciphylaxis on abdominal wall.Pre hero, k+ - 7.8 and multiple groin line sepsis.Line removed 48 hours post implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.The date of death is unknown.Multiple attempts were made to gather more information.The surgeon stated that he did not have the time to go through patient notes for further information and that he would not be supplying any further information.He stated he did not feel the issues he relayed in his email were hero related and that he was not reporting them.The surgeon also stated "i have no concerns regarding hero as a causative factor in any of these cases.I have not issued any form of complaint regarding these cases.Going through these cases retrospectively will not be necessary in my opinion." a review of manufacturing records could not be performed as lot numbers are unknown.Furthermore, shipping records could not be queried for possible lot numbers as the date of implant is unknown.A review was performed of the available information.This is a case of a patient implanted with a hero graft anastomosed to a flixene graft, who required a de-clot 2 months post-implant and at 4 months died secondary to calciphylaxis.Thrombosis is the most common cause of vascular access dysfunction and is listed as a potential complication in the hero instructions for use (ifu).In this case, patient history was significant for calciphylaxis, which is a syndrome of vascular calcification, thrombosis and skin necrosis.History of previous thrombosis was not available, but her medical condition put her at increased risk of clotting.The operative notes for the hero implant or intervention were not provided and the specific relationship between the hero graft and the observed occlusion cannot be assessed at this time.The surgeon noted that he did not feel that this event was hero related.Death is listed in the hero graft ifu as a potential intraoperative and post-operative complication.The ifu lists patient death as a potential post-operative complication with rates of 0% - 1.9% for patient's receiving a hero graft.The patient's condition at the time of death was described as "extreme end stage" and the surgeon noted that the patient had a pre-hero "k+ of 7.8 and multiple groin line sepsis." also, the cause of death was described as "calciphylaxix related to needling the graft." the patient reported here 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.However, the flixene graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.Thrombosis is a known complication of the hero graft.The cause of calciphylaxis, resulting in death, is related to the patient's underlying renal failure; neither complaint is hero graft related.

Event Description

According to the notification form, "(b)(6) female.Right lower limb, using flixene.Required 1 declot at 2 months.Patient rip 4 months post op secondary to calciphylaxis related to needling the graft.Extreme end stage access with previous calciphylaxis on abdominal wall.Pre hero, k+ - 7.8 and multiple groin line sepsis.Line removed 48 hours post implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.

Manufacturer Narrative

According to the notification form, "(b)(6) female.Right lower limb, using flixene.Required 1 declot at 2 months.Patient rip 4 months post op secondary to calciphylaxis related to needling the graft.Extreme end stage access with previous calciphylaxis on abdominal wall.Pre hero, k+ - 7.8 and multiple groin line sepsis.Line removed 48 hours post implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.Multiple attempts were made to gather more information.The surgeon stated that he did not have the time to go through patient notes for further information and that he would not be supplying any further information.He stated he did not feel the issues he relayed in his email were hero related and that he was not reporting them.The surgeon also stated "i have no concerns regarding hero as a causative factor in any of these cases.I have not issued any form of complaint regarding these cases.Going through these cases retrospectively will not be necessary in my opinion." a review of manufacturing records could not be performed as lot numbers are unknown.Furthermore, shipping records could not be queried for possible lot numbers as the date of implant is unknown.A review was performed of the available information.This is a case of a patient implanted with a hero graft anastomosed to a flixene graft, who required a de-clot 2 months post-implant and at 4 months died secondary to calciphylaxis.Thrombosis is the most common cause of vascular access dysfunction and is listed as a potential complication in the hero instructions for use (ifu).In this case, patient history was significant for calciphylaxis, which is a syndrome of vascular calcification, thrombosis and skin necrosis.History of previous thrombosis was not available, but her medical condition put her at increased risk of clotting.The operative notes for the hero implant or intervention were not provided and the specific relationship between the hero graft and the observed occlusion cannot be assessed at this time.The surgeon noted that he did not feel that this event was hero related.Death is listed in the hero graft ifu as a potential intraoperative and post-operative complication.The ifu lists patient death as a potential post-operative complication with rates of 0% - 1.9% for patient's receiving a hero graft.The patient's condition at the time of death was described as "extreme end stage" and the surgeon noted that the patient had a pre-hero "k+ of 7.8 and multiple groin line sepsis." also, the cause of death was described as "calciphylaxix related to needling the graft." the patient reported here 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.However, the flixene graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.Thrombosis is a known complication of the hero graft.The cause of calciphylaxis, resulting in death, is related to the patient's underlying renal failure; neither complaint is hero graft related.

Event Description

According to the notification form, "(b)(6) female.Right lower limb, using flixene.Required 1 declot at 2 months.Patient rip 4 months post op secondary to calciphylaxis related to needling the graft.Extreme end stage access with previous calciphylaxis on abdominal wall.Pre hero, k+ - 7.8 and multiple groin line sepsis.Line removed 48 hours post implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.

• 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 ; 7704193355
• MDR Report Key: 4922174
• MDR Text Key: 6052674
• Report Number: 1063481-2015-00118
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 07/12/2015
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 59 YR