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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

According to a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by inston et al.Implantations (august and october 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The paper identified a minor transient complication of "cool hand.".

Manufacturer Narrative

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

Manufacturer Narrative

According to a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by (b)(6) et al.Implantations (au(b)(6) and (b)(6) 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The poster identified a minor transient complication "cool hand" which occurred.Multiple attempts were made to gain additional information from mr.(b)(6); however all were unsuccessful.The symptom referred to as "cool hand" is consistent with steal syndrome.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from (b)(6) to (b)(6) with hero, and (b)(6) in arterio-venous grafts (avg).Steal syndrome is not unique to the hero graft and is a well-known complication of arteriovenous (av) access conduits, fistulas, prosthetics, biologics and xenografts.Without further details about the case, including treatment, it is unclear what impact this had on the patient.The patient transiently experienced "cool hand" after receiving the hero device.The description is consistent with steal syndrome.Steal syndrome is a known potential complication of the hero device due to shunting of arterial blood into the venous system.The root cause for the reported event is excessive shunting of arterial blood into the venous circulation.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.This known potential complication is common among all arteriovenous grafts, and does not suggest that there is a deficiency in the hero graft or the hero graft 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 a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by (b)(6) et al.Implantations ((b)(6) and (b)(6) 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The paper identified a minor transient complication of "cool hand.".

• 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: 4733639
• MDR Text Key: 15226866
• Report Number: 1063481-2015-00054
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• 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): Hospitalization; Required Intervention