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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

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 last three or four years dr.(b)(6) noted in patients with low flow state (congestive heart failure patients, specific number of patients not provided), he has had to declot hero grafts.He stated "it's like a ptfe in frequency of declotting." this medwatch form is submitted for product code hero 1001; however, both product codes hero 1001 and hero 1002 will be investigated.

Manufacturer Narrative

According to the report, over the last three or four years dr.(b)(6) noted in patients with low flow state (congestive heart failure patients, specific number of patients not provided), he has had to declot hero grafts.He stated "it's like a ptfe in frequency of declotting." this medwatch form is submitted for product code hero 1001; however, both product codes hero 1001 and hero 1002 will be investigated.Multiple attempts were made to obtain additional information, including the number of patients in which the surgeon has had to perform a declot, information regarding patient co-morbidities and/or operative notes for each case, when the occlusion was first noticed, how quickly after implant of the hero graft the occlusion occurred, and lot numbers of implanted hero grafts.However, all attempts were unsuccessful.A review of manufacturing records could not be performed as lot numbers for the hero devices are unknown.The dates of implants are unknown; therefore, shipping records could not be queried for possible lot numbers shipped to the hospital.A review was performed of the available information.The vascular surgeon commented that over the last 3 to 4 years there has been an unspecified number of hero graft patients with low flow state (i.E.Congestive heart failure patients) which have required declot procedures; the surgeon went on the state the hero graft declot frequency was "like a ptfe in frequency of declotting." additional information on specific patient cases, including operative/intervention notes, the specific number of de-clots, timeline of events, and medical history, was not provided.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The hero graft ifu mentions low blood flow or hypotension as a risk for hero graft occlusion.The specific relationship between the hero graft and the reported cases requiring declot procedures cannot be assessed at this time without additional information.The root cause of the reported event is unknown.The ifu lists the following potential complications with the use of the hero graft: 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 "verify the systolic blood pressure is at least 100mmhg.As with conventional grafts hero graft may occlude in patients with systemic low blood pressure or sever hypotension following fluid removal post dialysis" and "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 last three or four years dr.(b)(6) noted in patients with low flow state (congestive heart failure patients, specific number of patients not provided), he has had to declot hero grafts.He stated "it's like a ptfe in frequency of declotting." this medwatch form is submitted for product code hero 1001; however, both product codes hero 1001 and hero 1002 will be investigated.

• 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: 5058389
• MDR Text Key: 25097754
• Report Number: 1063481-2015-00215
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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: 08/06/2015
• 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