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

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Injury  

Event Description

According to the report by (b)(4), of cryolife's hero distributor (b)(4), on the (b)(6) association of nephrology nurses and technologists (cannt) meeting in (b)(6): (b)(6) presented on hero graft and their experience with 14 patients.6 of their 14 patients still have hero graft (7 deceased and 1 removed; 2 cited as graft related).They are very happy with the performance of hero graft (all implanted using flixene), but stress that the device is not a cure and patients should be carefully selected. as it is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.

Manufacturer Narrative

This investigation is currently ongoing.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.

Manufacturer Narrative

According to the report by the distributor during the (b)(6): representatives from (b)(6) presented on hero graft and their experience with 14 patients.6 of their 14 patients still have hero graft (7 deceased and 1 removed; 2 cited as graft related).They are very happy with the performance of hero graft (all implanted using flixene), but stress that the device is not a cure and patients should be carefully selected. as it is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.The following additional information was received on 12/11/2014: "the patient had the graft explanted due to steal syndrome.As such the integrity of the product was not in question." the vascular access coordinator had discussed this with the surgeon and he is in agreement that this case should not be considered a graft related event.Additional information was received from the complainant on 02/03/2015 and the complaint was re-opened at that time.The additional information is still under investigation.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report by (b)(6), of cryolife's hero distributor sorin, on the (b)(6) meeting in (b)(6): (b)(6) and (b)(6), from (b)(6) presented on hero graft and their experience with 14 patients.6 of their 14 patients still have hero graft (7 deceased and 1 removed; 2 cited as graft related).They are very happy with the performance of hero graft (all implanted using flixene), but stress that the device is not a cure and patients should be carefully selected.It was initially unknown which component of the hero device attributed to the alleged event thus reports were submitted for both components.This medwatch is for the hero 1001 component.Based on the additional information received it was determined that the hero 1001 component could not have attributed to the adverse event.Thus this is the final report submitted for hero 1001.͊ additional information was received on 02/03/2015 from the hospital.The hospital stated: "the hero graft was inserted on (b)(6).She was admitted post-operatively for observation and dialysis.On post-operative day 1, her blood pressure remained very low in the 80s-90s mm hg systolic and as such the graft occluded and she was brought back emergently to the o.R.For thrombectomy.This was successful but within a few hours she developed severe vascular ischemic steal in her left hand and had to be returned to the or that same night for explantation of the hero graft and replacement with a new left internal jugular catheter." the patients comorbidities were as follows: hypertension, impaired glucose tolerance, membranous glomerulonephropathy, multiple failed av fistulas, nephrectomy 2014, peritoneal dialysis peritonitis, previous failed renal transplant, diabetes, dyslipidemia, hypertension.

Manufacturer Narrative

According to the report by the distributor during the (b)(6): representatives from (b)(6) presented on hero graft and their experience with 14 patients.6 of their 14 patients still have hero graft (7 deceased and 1 removed; 2 cited as graft related).They are very happy with the performance of hero graft (all implanted using flixene), but stress that the device is not a cure and patients should be carefully selected. as it is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.The following additional information was received on 12/11/2014: "the patient had the graft explanted due to steal syndrome.As such the integrity of the product was not in question." the vascular access coordinator had discussed this with the surgeon and he is in agreement that this case should not be considered a graft related event.A review was performed of the available information, the instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero and 3.8% in arteriovenous graft (avg).Steal syndrome is a known complication of the hero device cause shunting of arterial blood into the venous system.Steal syndrome is not unique to hero graft and is a well-known complication of hemodialysis conduits and may be managed by ligation or explant.According to the information provided, all of the patients had procedure modification to include flixene graft attached to a small portion of arterial graft component.This is a modification to the device, so cryolife cannot support this modification as it is not an approved indication/modification to the device.The ifu provides adequate instructions to implant the graft in the approved configuration but no allowance is made for off label use.Clinical outcomes with a modified device have not been evaluated by cryolife.

Event Description

According to the report by (b)(6), of cryolife's hero distributor (b)(4), on (b)(6) meeting in (b)(6) presented on hero graft and their experience with 14 patients.6 of their 14 patients still have hero graft (7 deceased and 1 removed; 2 cited as graft related).They are very happy with the performance of hero graft (all implanted using flixene), but stress that the device is not a cure and patients should be carefully selected.It is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4238947
• MDR Text Key: 5019110
• Report Number: 3006945290-2014-00090
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2014

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
• Device Lot Number: H14VC022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2015; 02/19/2015
• 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