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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

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 notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.Two grafts were lost due to thrombosis.Neither had a history of hypercoagulable disorder and both were on daily aspirin at the time of graft placement.One had 146 days of primary patency, 21 days of secondary patency, and occluded a third time 12 days after the second thrombectomy despite being on warfarin.The second had 60 days of primary patency and less than 1 day of secondary patency.This investigation is relegated to the first of two incidents of thrombosis and subsequent graft failure.Both hero 1001 and 1002 components will be investigated, but will be reported under hero 1001.

Manufacturer Narrative

According to the notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.Two grafts were lost due to thrombosis.Neither had a history of hypercoagulable disorder and both were on daily aspirin at the time of graft placement.One had 146 days of primary patency, 21 days of secondary patency, and occluded a third time 12 days after the second thrombectomy despite being on warfarin.The second had 60 days of primary patency and less than 1day of secondary patency.This investigation is relegated to the first of two incidents of thrombosis and subsequent graft failure.Both hero 1001 and 1002 components will be investigated, but will be reported under hero 1001.Multiple attempts to obtain additional clarifying information from the corresponding author of the publication were made without success.Emails were sent on 02/23/2016 and 03/09/2016 and a letter was sent on 03/09/2016 without response.Manufacturing records were not reviewed as definitive lot numbers are unavailable.The system could not be queried for potential lots shipped to the hospital as dates of implant are unknown.Davis et al.Published the article entitled, "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" online in january of 2016.The retrospective review documents the following adverse events in a set of 11 patients with superior vena cava (svc) occlusion: steal, thrombosis, death (unrelated to the hero graft), acute ischemic stroke, pneumonia, wound dehiscence, pacemaker wire dislodgement, bleeding requiring transfusion, acute psychosis, and bacteremia.The surgeons implanted the hero graft using the inside-out central venous access technique (iocva) to traverse the occluded vena cava.The description of the technique can be found in the publication.Additionally, the hero graft was placed in a two-step process for five of the eleven patients.The known medical history reported for the sample included previous dependency on a tunneled femoral catheter, history of multiple failed accesses, 8 patients with coronary artery disease (cad) and 7 patients with diabetes.Two patients were reported to have thrombosis events which resulted in graft failure.One patient had 146 days of primary patency, 21 days of secondary patency, and occluded a third time 12 days after the second thrombectomy despite treatment with warfarin.The other patient had 60 days of primary patency and less than 1 day of secondary patency.Both patients were reported to have no history of hypercoagulable disorder and both were on a daily aspirin regime at time of hero graft placement.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use ifu, as is prosthesis failure.Thrombosis is the most common cause of vascular access dysfunction.Missed hemodialysis sessions significantly increase the number of thrombosis episodes in avfs and avgs.Additional information on patient medical history, implant and intervention notes, and dialysis information was not provided.Without additional information the relationship between the thrombosis events and the hero graft cannot be determined.The patients reported here had a procedure modification, as the surgeons chose to implant with the iocva approach.The hero graft ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft implanted with the iocva technique have not been evaluated by cryolife and therefore there is no data on anticipated adverse events.The following complications were reported with limited additional information within the publication, but were not documented to be directly related to the hero graft: pneumonia, wound dehiscence, pacemaker wire dislodgement, bleeding, and psychosis.One patient had pneumonia requiring hospitalization within 30 days of hero placement.This patient was documented to have frequent lung infections and chronic pleural effusion.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.The patient's pertinent medical history of lung infections would increase the risk of pneumonia.One patient had wound dehiscence, which was noted in a follow-up appointment within 30 days of hero placement.There was no exposed graft documented and the tissue was re-approximated after washout in the operating room.The patient was treated with a 3-week course of iv antibiotics.The graft was reported to be operational at the time of the publication.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.One patient had a case of pacemaker wire dislodgement within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.One patient had a case of bleeding requiring transfusion within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.The source of the bleeding was not reported.One patient had a case of acute psychosis within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.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 notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.Two grafts were lost due to thrombosis.Neither had a history of hypercoagulable disorder and both were on daily aspirin at the time of graft placement.One had 146 days of primary patency, 21 days of secondary patency, and occluded a third time 12 days after the second thrombectomy despite being on warfarin.The second had 60 days of primary patency and less than 1day of secondary patency.This investigation is relegated to the first of two incidents of thrombosis and subsequent graft failure.Both hero 1001 and 1002 components will be investigated, 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: 5451761
• MDR Text Key: 38745788
• Report Number: 1063481-2016-00024
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• 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): Other