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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

According to the publication, "report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions", 2 hero-related bacteremia events occurred, one at four months and the other at seven months, and both required explantation.As it is unknown which component of the hero device, if any, attributed to the adverse event it was decided out of an abundance of caution to investigate both.This medwatch is for the hero 1002 component.

Manufacturer Narrative

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

Manufacturer Narrative

According to the publication, report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions, two hero-related bacteremia events occurred, one at four months and the other at seven months, and both required explanation.Multiple attempts were made to gain additional information from dr.(b)(6), one of the co-authors; however, all attempts were unsuccessful.The instructions for use (ifu) report on the infection (bacteremia) rates for patient's receiving a hero graft.Although it is much lower than patient's using catheters or synthetic grafts, there is still a potential for a bacteremic episode with a hero graft.The ifu additionally discusses proper patient selection, prophylactic antibiotic usage and cannulation technique to potentially mitigate bacteremic episodes.All implants were for upper extremity access and comorbidities for the patient cohort are described with in the publication and are similar to those reported for hemodialysis access patients.The authors indicate that a tunneled dialysis catheter (tdc) was used during the bridging period.The presence of the tdc increases the risk for infection in these patients.Since there are two independent devices in these patients at the time of the reported bacteremia, a direct correlation of the bacteremia to the hero graft cannot be made at this time.Explant of the device in the presence of an ongoing infection is a clinically established treatment for arteriovenous (av) access devices.Two patients developed bacteremia four and seven months respectively, after receiving a hero device.There is insufficient information to determine the relationship between the reported event and the hero device.Secondary infection of indwelling vascular catheters is a well-established complication of these devices.A primary infection caused by the hero device is unlikely since the device undergoes a validated sterilization process.Without additional information the relationship of the infection to the hero graft device and the patient cannot be determined.A root cause for this event is unknown.Infection is a known potential complication listed in the hero graft instructions for use (ifu).The hero graft ifu contraindicates use of the hero device in patients with known preexisting bacteremia.In addition, instructions for screening blood cultures to rule out asymptomatic bacteremia and recommended antibiotic therapy are also provided in the ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the publication, "report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions", 2 hero-related bacteremia events occurred, one at four months and the other at seven months, and both required explantation.As it is unknown which component of the hero device, if any, attributed to the adverse event it was decided out of an abundance of caution to investigate both.This medwatch is for the hero 1002 component.

• 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: 4496131
• MDR Text Key: 5438369
• Report Number: 1063481-2015-00021
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• 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: 01/28/2015
• 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): Hospitalization; Other