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

Model Number HERO 1001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Air Embolism (1697); Thrombosis (2100); Pseudoaneurysm (2605)

Event Date 09/30/2012

Event Type  Injury  

Event Description

According to the report, hero patient, 001-004, was implanted with a hero graft on (b)(6) 2009.The 30-month follow-up form reports a hospitalization for "asthma exacerbation".The 36-month follow-up form reports a percutaneous angioplasty in (b)(6) 2012.The 66-month follow-up form reports three clotting events which required percutaneous angioplasty between december of 2014 and january of 2015.A graft pseudoaneurysm was noted on (b)(6) 2014.In (b)(6) 2015 the patient was also reported to have an acute pulmonary embolism.The 72-month follow-up form was not entered, but the coordinator e- mailed notes which document a graft revision and thrombectomy in (b)(6) 2015.The scope of the investigation will include both hero 1001 and 1002 components but will be submitted 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: 5567431
• MDR Text Key: 213861253
• Report Number: 1063481-2016-00009
• 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 Health Care Professional
• 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: 0000247
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2016
• 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): Life Threatening; Hospitalization; Other
• Patient Age: 47 YR