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

Model Number HERO 1002

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Failure to Anastomose (1028); Blood Loss (2597)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

The hospital didn't have a gore tunneler with a protective sheath, so they used a standard tunneler to make a large loop with the av graft.While tunneling to the sfa the nylon suture broke a few time because of the force trying to tunnel.After completing the tunneling and connecting the graft to outflow component, he back bled the graft and started to do the arterial anastomosis.After completing the anastomosis, the surgeon noticed a lot of sweating or weeping of blood through the graft.This patient is very hypercoagulopatic, so the heparin was administered throughout the case.After waiting for an act to see about reversing the heparin thinking this might help stop the weeping.After about 5 minutes of waiting and soaking the visible segments of the graft with gel foam and thrombin, it started to look better, so he proceeded with closing the incisions.

Manufacturer Narrative

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

Manufacturer Narrative

The hospital didn't have a gore tunneler with a protective sheath, so they used a standard tunneler to make a large loop with the arteriovenous (av) graft.While tunneling to the superficial femoral artery (sfa) the nylon suture broke a few times because of the force trying to tunnel.After completing the tunneling and connecting the graft to outflow component, he back bled the graft and started to do the arterial anastomosis.After completing the anastomosis, dr.Macherla noticed a lot of sweating or weeping of blood through the graft.This patient is very hypercoagulopatic so the heparin was administered throughout the case.After waiting for an activated clotting time (act) to see about reversing the heparin thinking this might help stop the weeping.After about 5 minutes of waiting and soaking the visible segments of the graft with gel foam and thrombin it started to look better, so he proceeded with closing the incisions.Multiple attempts were made to acquire additional information, all of which were unsuccessful.The manufacturing records for potential lots were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A seroma is a collection of sterile, clear, ultrafiltered serum surrounded by a nonsecretory fibrous pseudocapsule.Seromas have been reported with both dacron and polytetrafluoroethylene (ptfe) grafts, most commonly when they are placed in subcutaneous locations and are sometimes referred to as a weeping graft.Early seromas are not uncommon with prosthetic a-v grafts and frequently resolve without intervention.As this event may not be a true seroma, given the fact that the weeping was not contained within the subcutaneous tissue, it is plausible that the observed event was the ultrafiltered serum described above and therefore is a known vascular access occurrence/complication reported with ptfe grafts.The level of heparinization (concentration) is unknown as is the type(s) and/or concentration(s) of any additional medications this patient may be taking, therefore no conclusion can be made as to the impact any of these medications may have on this observed event.The root cause for this event is unknown due to limited information from the hospital.If the event does in fact represent a seroma it is a known potential complication of the hero graft which is outlined in the device's ifu.Seromas 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.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

The hospital didn't have a gore tunneler with a protective sheath, so they used a standard tunneler to make a large loop with the av graft.While tunneling to the sfa the nylon suture broke a few time because of the force trying to tunnel.After completing the tunneling and connecting the graft to outflow component, he back bled the graft and started to do the arterial anastomosis.After completing the anastomosis, the surgeon noticed a lot of sweating or weeping of blood through the graft.This patient is very hypercoagulopatic so the heparin was administered throughout the case.After waiting for an act to see about reversing the heparin thinking this might help stop the weeping.After about 5 minutes of waiting and soaking the visible segments of the graft with gel foam and thrombin it started to look better, so he proceeded with closing the incisions.

• 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: 4238943
• MDR Text Key: 19308398
• Report Number: 3006945290-2014-00085
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• 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