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

Model Number HERO 1001

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

According to the notification form, "(b)(6) male.Right upper limb, using flixene 6 month patent.1 year, required stent graft for needling related pseudoaneurysm.Dialysing well at 14 months.Line removed at time of implant.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the notification form, "(b)(6) old male.Right upper limb, using flixene 6 month patent.One year, required stent graft for needling related pseudoaneurysm.Dialysing well at 14 months.Line removed at time of implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to gather more information.The surgeon stated that he did not have the time to go through patient notes for further information and that he would not be supplying anything any further information.He stated he did not feel the issues he relayed in his email were hero related and that he was not reporting them.The surgeon also stated "i have no concerns regarding hero as a causative factor in any of these cases.I have not issued any form of complaint regarding these cases.Going through these cases retrospectively will not be necessary in my opinion." a review of manufacturing records could not be performed as lot numbers are unknown.Furthermore, shipping records could not be queried for possible lot numbers as the date of implant is unknown.A review was performed of the available information.In this case a patient implanted with a hero graft anastomosed to a flixene graft, incurred a pseudoaneurysm formation that was noted one year post-implant.The hero graft instructions for use (ifu) list pseudoaneurysm as a potential vascular graft and catheter complication.According to the surgeon notes, the pseudoaneurysm was related to "needling".As stated in the ifu, rotation of cannulation sites is needed to avoid pseudoaneurysm formation.Details of dialysis sessions were unknown and compliance with rotation cannot be confirmed.Operative notes and patient history is also not available at this time.The surgeon chose to stent the graft and patency was restored and has been successfully maintained.The surgeon noted that he did not feel that this event was hero related.The patient reported here had a procedure modification to include flixene graft attached to the arterial graft component.The ifu provided adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with a flixene graft have not been evaluated by cryolife.However, the flixene graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.The root cause /conclusion is that the pseudoaneurysm described was related to cannulation of the flixene graft and is not hero graft related.

Event Description

According to the notification form, "(b)(6) old male.Right upper limb, using flixene 6 month patent.One year, required stent graft for needling related pseudoaneurysm.Dialysing well at 14 months.Line removed at time of implant." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.

• 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: 4922116
• MDR Text Key: 19611908
• Report Number: 1063481-2015-00116
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2015
• Initial Date FDA Received: 07/17/2015
• 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; Required Intervention
• Patient Age: 55 YR