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

Model Number HERO 1002

Device Problem Degraded (1153)

Patient Problem No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Event Description

According to the report, the patient was implanted with hero graft on (b)(4) 2014.Dr.(b)(6) did a revision of the graft portion today, due to "graft decay".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, the patient was implanted with hero graft on (b)(6) 2014.Dr.(b)(6) did a revision of the graft portion today, due to "graft decay".Attempts were made to gain additional information from the surgeon on (b)(6) 2015; however, all attempts were unsuccessful.The hero arterial graft connector was returned and an evaluation was performed on 07/09/2015.The ptfe had been cut open through the beading and thrombosis could be seen attached to the wall.Blood could be seen under the connector.There was no sign of "decay." the cryolife representative provided insight on what the surgeon meant by "decay." she said it was related to punctures cause by cannulation of the graft and the graft now "falling apart." she also confirmed that the connector was not returned in relation to the reported decay.Dr.(b)(6) wished for the connector to be sent back to be evaluated to provide further support to his theory on how the connector causes thrombus formation.The manufacturing records for lot h13av037 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.The patient was implanted with a hero graft in 2014 and recently had a graft revision, which was described as "due to graft decay." it is unclear what patient presentation or symptomology prompted the revision.The connector was returned to cryolife with a small portion of the arterial graft component (agc) attached.Upon review, there was a thrombosis attached to the wall of the agc and there were no additional defects visible.Thrombosis is the most common cause of vascular access dysfunction and a potential complication listed in the hero ifu.It is unclear if any additional interventions were performed at the time of the agc revision.Patient medical history and operative notes were not available.At this time, the role of the hero graft in the aforementioned thrombosis event and revision cannot be determined.The issue of "graft decay" was not confirmed upon sample review.Further clarification on what was meant by decay confirmed that the surgeon found graft was "falling apart" related to punctures caused by graft cannulation/ the agc section used for cannulation was not sent for sample review.Furthermore, operative notes and dialysis information were not available for further clarification of the events.However, the hero ifu lists vascular graft revision/replacement and prosthesis failure as potential vascular graft and catheter complications.At this time, the role of the hero graft in the aforementioned "graft decay" cannot be determined.The root cause for the reported events is unknown; however, all complications noted in the complaint are known potential complications of the hero graft.The ifu lists the following potential complications with the use of the hero graft: vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, and prosthesis failure.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 patient was implanted with hero graft on (b)(6) 2014.Dr.(b)(6) did a revision of the graft portion today, due to "graft decay".

• 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: 4894292
• MDR Text Key: 21545001
• Report Number: 1063481-2015-00108
• 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,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2015

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 1002
• Device Lot Number: H13AV037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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