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

Model Number HERO 1001

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); 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, over the past three years the radiologist has had to provide additional (new) access in 20-25 patients due to hero graft failures.This report represents the second of 25 patients.

Manufacturer Narrative

According to the report, over the past three years the radiologist has had to provide additional (new) access in 20-25 patients due to hero graft failures.This report represents the second of 25 patients.Although hero 1001 is listed as the product code, both hero 1001 and hero 1002 were investigated.Multiple attempts were made to contact the complainant for additional information; however, all attempts were unsuccessful.Manufacturing records could not be reviewed as lot numbers were not provided.Possible lot numbers could not be determined as dates of implant were unknown.A review was performed of the available information.Twenty to twenty five patients required additional (new) access after hero graft failures "over the last 3 years." the hero graft ifu lists prosthesis failure as a potential vascular graft and catheter complication.The following information was not available: patient medical history, implant operative notes, and intervention operative notes.The specific relationship between the hero graft and the cases of hero graft failure cannot be assessed at this time without additional information.The ifu lists the following potential complications with the use of the hero graft: prosthesis failure, and partial stenosis or full occlusion of prosthesis or vasculature.The ifu states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft." the ifu also states "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication.".

Event Description

According to the report, over the past three years the radiologist has had to provide additional (new) access in 20-25 patients due to hero graft failures.This report represents the second of 25 patients.

• 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: 5021611
• MDR Text Key: 23711262
• Report Number: 1063481-2015-00176
• 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,study
• Reporter Occupation: Physician
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• 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