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

Model Number HERO 1001

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Thrombosis (2100); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the report, book draft chapter 20: the hemodialysis reliable outflow graft(hero), discusses technique for implanting a hero graft and reviews current literature on the topic.The chapter also discusses a specific case of occlusion and provides a photo.The scope of the investigation will include both hero 1001 and 1002 components but will reported under hero 1001.

Manufacturer Narrative

According to the report, book draft chapter 20: the hemodialysis reliable outflow graft(hero), discusses technique for implanting a hero graft and reviews current literature on the topic.The chapter also discusses a specific case of occlusion and provides a photo.The manuscript chapter addresses the use of the hero graft as a means of vascular access and cites several publications as a source of supporting information.Complications of the hero graft are addressed in the chapter and include thrombosis/stenosis/occlusion, infection, steal syndrome, and costoclavicular impingement (investigated via complaint (b)(4)).The source of all reported adverse events have either been addressed in previous complaints or are a part of the initial device clinical trials which are referenced in the hero graft instructions for use.Based on this information, complaint (b)(4) will be voided.Departmental reports were not requested as a determination was made to void the complaint prior to their request.

Event Description

According to the report, book draft chapter 20: the hemodialysis reliable outflow graft(hero), discusses technique for implanting a hero graft and reviews current literature on the topic.The chapter also discusses a specific case of occlusion and provides a photo.The scope of the investigation will include both hero 1001 and 1002 components but will reported under hero 1001.

• 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: 5314726
• MDR Text Key: 34000193
• Report Number: 1063481-2015-00361
• 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: health professional,literatur
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• 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
• Patient Outcome(s): Other; Required Intervention