MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HERO 1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 08/30/2015

Event Type  Death  

Event Description

According to the initial report, a hero patient "(b)(6) was implanted with a graft on (b)(6) 2015.The coordinator reported today that the patient "expired prior to his one month visit".Date of death was (b)(6) 2015, ruled cardiac arrest." the scope of the investigation will include both hero 1001 and 1002 components, but will be reported under hero 1001.

• Brand Name: HERO GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5407046
• MDR Text Key: 213832770
• Report Number: 1063481-2016-00012
• 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: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2020

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: Health Professional
• Device Model Number: HERO 1001
• Device Lot Number: H14VC048, H15AV002
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Sex: Male