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

Model Number HERO 1001

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, two hero graft failed due to poor inflow.As it is unknown which component of the hero graft, if any, was responsible for the adverse event it was decided out of an abundance of caution both would be investigated.This report represents the hero 1001 product code.

Manufacturer Narrative

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

Manufacturer Narrative

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, two hero graft failed due to poor inflow.Additional information was received on 1/23/2015.The first patient's date of implant is (b)(6) 2013 and the second patient's date of implant (b)(6) 2013.Multiple attempts were made to gain additional information, including the lot numbers, date of implant, date of adverse event, and information surrounding the events.This information was requested from cryolife representative, on 12/18/2014, to which no response was received.Information was again requested from cryolife representative on 1/12/2015.He responded that he reached out by email and phone to contact the surgeon's access coordinator; she indicated she would compile all available information.The cryolife representative emailed the surgeon's access coordinator again on 1/20/2015 requesting additional information.The surgeon's access coordinator responded that she was working on it.She emailed the cryolife representative on 1/23/2015 giving the dates of implant.She stated, "that is all i can get for you." a query was performed in sap for all lot numbers shipped to the hospital from (b)(6) 2012 to (b)(6) 2013 to determine possible lot numbers that could have been used during the event.Eight possible lot numbers for hero 1001 were identified: 0001791, 0001801, 0001802, 0001806, 0001809, 0001825, 0001857, and 0001872.5 possible lot numbers for hero 1002 were identified: 0001839, 0001850, 0001871, 0001898, and 0001917.The manufacturing records for the 13 possible lot numbers (both hero 1001 and hero 1002) were reviewed, and it was confirmed that all records were controlled available for review, and met all specifications per device master record.The article states two hero grafts failed due to poor inflow.The article further states that it is important to maintain adequate blood flow through the entire length of the device.The ifu recommend that a patient have an ejection fraction of at least 20% and the target artery must have an internal diameter of at least 3 mm to provide adequate arterial inflow to support the graft at the time of device implant.The hero graft ifu also lists a small brachial artery and insufficient arterial inflow or inflow stenosis as reasons why the hero graft may occlude.The ifu also states that during implant the surgeon should check the device patency utilizing the standard doppler technique.The ejection fraction, implanting technique, and/ or the presence of other circulatory problems in these two patients is unknown.Adequate precautions regarding maintenance of adequate flow and implantation of the hero device are provided in the ifu.All of the patients reported in this series had procedure modification to include flixene graft attached to a small portion of the agc.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.The root cause for the reported event is unknown.The hero graft ifu lists prosthesis failure, partial stenosis or full occlusion of the prosthesis or vasculature as known potential complications.These known potential complications are common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, two hero graft failed due to poor inflow.As it is unknown which component of the hero graft, if any, was responsible for the adverse event it was decided out of an abundance of caution both would be investigated.This report represents the hero 1001 product code.

Manufacturer Narrative

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, two hero graft failed due to poor inflow.Additional information was received on 1/23/2015.The first patient's date of implant is (b)(6) 2013 and the second patient's date of implant (b)(6) 2013.Multiple attempts were made to gain additional information, including the lot numbers, date of implant, date of adverse event, and information surrounding the events.This information was requested from cryolife representative, on 12/18/2014, to which no response was received.Information was again requested from cryolife representative on 1/12/2015.He responded that he reached out by email and phone to contact the surgeon's access coordinator; she indicated she would compile all available information.The cryolife representative emailed the surgeon's access coordinator again on 1/20/2015 requesting additional information.The surgeon's access coordinator responded that she was working on it.She emailed the cryolife representative on 1/23/2015 giving the dates of implant.She stated, "that is all i can get for you." a query was performed for all lot numbers shipped to the hospital from (b)(6) 2012 to (b)(6) 2013 to determine possible lot numbers that could have been used during the event.Eight possible lot numbers for hero 1001 were identified: 0001791, 0001801, 0001802, 0001806, 0001809, 0001825, 0001857, and 0001872.5 possible lot numbers for hero 1002 were identified: 0001839, 0001850, 0001871, 0001898, and 0001917.The manufacturing records for the 13 possible lot numbers (both hero 1001 and hero 1002) were reviewed, and it was confirmed that all records were controlled available for review, and met all specifications per device master record.The article states two hero grafts failed due to poor inflow.The article further states that it is important to maintain adequate blood flow through the entire length of the device.The ifu recommend that a patient have an ejection fraction of at least 20% and the target artery must have an internal diameter of at least 3 mm to provide adequate arterial inflow to support the graft at the time of device implant.The hero graft ifu also lists a small brachial artery and insufficient arterial inflow or inflow stenosis as reasons why the hero graft may occlude.The ifu also states that during implant the surgeon should check the device patency utilizing the standard doppler technique.The ejection fraction, implanting technique, and/ or the presence of other circulatory problems in these two patients is unknown.Adequate precautions regarding maintenance of adequate flow and implantation of the hero device are provided in the ifu.All of the patients reported in this series had procedure modification to include flixene graft attached to a small portion of the agc.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.The root cause for the reported event is unknown.The hero graft ifu lists prosthesis failure, partial stenosis or full occlusion of the prosthesis or vasculature as known potential complications.These known potential complications are common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the article, modification of the hero graft allowing earlier cannulation and reduction in catheter dependent days in patients with end stage renal disease: a single center retrospective review, two hero graft failed due to poor inflow.As it is unknown which component of the hero graft, if any, was responsible for the adverse event it was decided out of an abundance of caution both would be investigated.This report represents the hero 1001 product code.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT-PROSTHESIS
• 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: 4357702
• MDR Text Key: 5116614
• Report Number: 3006945290-2014-00110
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• 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: 12/10/2014
• 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