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

Model Number HERO 1002

Device Problem Complete Blockage (1094)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

Add'l model #hero 1002, add'l lot #h15av001.(b)(4).This investigation is currently ongoing.Any add'l info will be provided in the f/u report.

Event Description

According to the report, "hero graft implantation [took place] (b)(6) 2015.Primary implantation of hero with combination accuseal of distal a.Brachialis.[on] (b)(6) 2015, closure and thrombectomy hero and accuseal (gore)." there was repeated surgical procedure with the thrombectomy.Although this report is submitted for product code 1001, both product codes hero 1001 and hero 1002 are investigated.

Manufacturer Narrative

According to the report, "hero graft implantation [took place] (b)(6) 2015.Primary implantation of hero with combination accuseal of distal a.Brachialis.[on] (b)(6) 2015, closure and thrombectomy hero and accuseal (gore)." there was repeated surgical procedure with the thrombectomy.Multiple contact attempts were made to obtain additional information including date of implant and lot number, the date of the occlusion, the date of the thrombectomy, patient impact, and any other patient information available.The following additional information was received: lot number h15av001, no information provided for exact implant date, an occlusion of the arterial graft component (agc) occurred sometime in (b)(6) 2015, a thrombectomy was done sometime after occlusion and surgical intervention was the only patient impact, and there was no other patient information available.The manufacturing records for lot h15av001 were reviewed and it was confirmed that all records were controlled, available for review, and met all release specifications per the device master record.A review was preformed of the available information.This patient was implanted with a hero graft in (b)(6) 2015 (exact date is unknown).The graft was implanted with the agc anastomosed to an acuseal vascular graft.The graft was implanted with unknown arterial anastomosis or venous access point.In (b)(6) 2015 the patient developed an occlusion of the agc and a thrombectomy was performed (exact date is unknown).Surgical intervention is the only known patient impact in this case and no additional information is available, including patient medical history, implant/intervention notes, intervention outcome and dialysis information (including complication).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 specific relationship between the thrombosis/occlusion events and the hero graft was not documented; additional information is needed to determine this relationship.The patient reported here had a procedure modification to include the acuseal graft attached to the agc.The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with an acuseal graft have not been evaluated by cryolife.The acuseal graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.The cause of the occlusion event is unknown; however, occlusion is a known outcome.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, "hero graft implantation took place (b)(6) 2015.Primary implantation of hero with combination accuseal of distal a.Brachialis.On (b)(6) 2015, closure and thrombectomy hero and accuseal (gore)." there was repeated surgical procedure with the thrombectomy.

• 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: 5391259
• MDR Text Key: 84001506
• Report Number: 1063481-2015-00351
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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: Physician
• Device Model Number: HERO 1002
• Device Catalogue Number: HERO 1002
• Device Lot Number: H15AV001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: 10/29/2015
• Supplement Dates FDA Received: 01/26/2016
• 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): Other