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

Model Number HERO 1002

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.Manufacturing records for lot h15av002 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft instructions for use (ifu) states "cut the arterial graft component to length, avoiding excessive tension or excess material.Verify there are no kinks, twists, or bends in the arterial graft component.If damage to the beading is noted during implant, a new arterial graft component should be used." the ifu lists device kinking and compression as a potential complication with the use of hero graft.The root cause for the reported event is unknown.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.

• Brand Name: HERO GRAFT ARTERIAL GRAFT COMPONENT
• 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: 4775851
• MDR Text Key: 17579714
• Report Number: 1063481-2015-00063
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1002
• Device Lot Number: H15AV002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• 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