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

Model Number HERO 1002

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the report received by the cryolife representative, "i am at the veith symposium today and [the surgeon] came by the booth and discussed his recent issue with out ptfe graft pinching after implantation.He wishes to attach a different graft to the hero graft than our standard ptfe graft.".

Manufacturer Narrative

According to the report, "at the veith symposium today and [the surgeon] came by the booth and discussed his recent issue with our ptfe graft pinching after implantation.He wishes to attach a different graft to the hero graft than our standard ptfe graft." multiple attempts were made to obtain further information including the number of events encountered "pinching", dates of implant and dates of revisions or interventions, lot numbers, any operative notes and/or progress notes, as well as if the hero 1002 was the sole graft component used or if modifications were made utilizing other graft material.An email was sent on (b)(4) 2015, a letter was sent on (b)(4) 2015 and a second sent on (b)(4) 2015, to date no response has been received.A review of manufacturing records was not requested as lot numbers for the hero device are unknown.A review of the available information was performed.The patient was implanted with a hero graft on an unknown date.The surgeon reported that the "graft is pinching causing the graft to not work properly." the surgeon went on to say the pinching occurred after implant and he expressed the desire to use a different graft, other than the ptfe graft that comes with the hero graft.No additional information was provided including information on the source of the "pinching", and the direct impact on the patient, any required interventions, any diagnostic images illustrating the problem and patient medical history.The hero graft instructions for use (ifu) lists prosthesis failure and device compression as potential vascular graft and catheter complications.However, without additional information, the relationship between the hero graft and the reported graft pinching cannot be determined.The root cause of the graft pinching is unknown.The ifu provides the following instructions: "verify there are no kinks, twists, or bends in the arterial graft component.If damaged to the beading is noted during implant, a new arterial graft component should be used." the ifu lists the following potential complications with the use of the hero graft: prosthesis failure and device kinking or compression.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

According to the report, "at the veith symposium today and [the surgeon] came by the booth and discussed his recent issue with our ptfe graft pinching after implantation.He wishes to attach a different graft to the hero graft than our standard ptfe graft.".

• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5312225
• MDR Text Key: 33922404
• Report Number: 1063481-2015-00359
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2015
• 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