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

Model Number HERO 1002

Device Problems Complete Blockage (1094); Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Thrombosis (2100); No Information (3190)

Event Date 07/06/2015

Event Type  Injury  

Event Description

According to the notification form, "dr.(b)(6) placed a left arm hero graft at (b)(6) on (b)(6) 2015.Patient clotted and he and dr.(b)(6) had to do a revision today with a 40 cm procol graft.They exposed the axillary and then cut down and ligated the existing avg at the brachial anastomosis.Used a 4 fogarty and made several passes throughout the entire hero graft to declot the graft.Connected the two grafts end-to-end near the brachial artery.Confirmed patency and closed.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, "dr.(b)(6) placed a left arm hero graft at community south on (b)(6) 2015.Patient clotted and he and dr.(b)(6) had to do a revision today with a 40 cm procol graft.They exposed the axillary and then cut down and ligated the existing avg at the brachial anastomosis.Used a 4 fogarty and made several passes throughout the entire hero graft to declot the graft.Connected the two grafts end-to-end near the brachial artery.Confirmed patency and closed." the hospital was unable to provide the lot number of the hero arterial graft component implanted on (b)(6) 2015.Shipping records were queried and lots h14av027 and h15av003 were identified as having been shipped to the hospital in the six months prior to the implant.The manufacturing records for lots h14av027 and h15av003 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.The patient was implanted with a hero graft in early (b)(6) 2015.In early (b)(6) 2015, the patient clotted.Partial stenosis or full occlusion of prosthesis or vasculature is listed on the hero instructions for use (ifu) as a potential vascular graft and catheter complication.In this case, the surgeon chose to treat the clot with a graft revision using a 40cm procol graft.The procol graft was attached end-to-end with the arterial graft component near the brachial artery.Before the connection, the surgeon used a "4 fogarty" to declot the entire hero graft.At the end of the procedure patency was confirmed.The ifu lists vascular graft revision/replacement as a potential treatment for vascular graft and catheter complication.Patient medical history was not provided and therefore the risk of clots due to patient characteristics cannot be assessed.An increased risk for graft thrombosis could be caused by a hypercoagulability state or impaired blood flow through the graft.Precautions regarding inadequate anticoagulation are provided in the hero ifu.Operative notes were also unavailable and it cannot be determined if there were any deviations from the suggested implantation methodology.It is also unclear why the surgeon chose to revise the agc with a procol graft.At this time, the role of the hero graft in the aforementioned clotting cannot be determined.The ifu lists the following potential complications with the use of the hero graft: vascular graft revision/replacement and partial stenosis or full occlusion of prosthesis or vasculature.

Event Description

According to the notification form, "dr.(b)(6) placed a left arm hero graft on (b)(6) 2015.Patient clotted and he and dr.(b)(6) had to do a revision today with a 40 cm procol graft.They exposed the axillary and then cut down and ligated the existing avg at the brachial anastomosis.Used a 4 fogarty and made several passes throughout the entire hero graft to declot the graft.Connected the two grafts end-to-end near the brachial artery.Confirmed patency and closed.".

• 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: 4918170
• MDR Text Key: 6010053
• Report Number: 1063481-2015-00110
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Device Lot Number: H14AV027 OR H15AV003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• 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): Required Intervention