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 Pain (1994); Numbness (2415)

Event Date 09/04/2015

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, "after surgery patient reported numbness in the arm and hand along with severe pain.Surgeon took patient to or and ligated the graft.".

Manufacturer Narrative

According to the report, "after surgery patient reported numbness in the arm and hand along with severe pain.Surgeon took patient to or and ligated the graft." the following additional information was received: date of implant is (b)(6) 2015, steal syndrome was identified the same day as implant in the post-operative care unit, patient impact consisted of surgical intervention as the patient was taken back to the or after steal syndrome was identified and the hero was ligated, patient is receiving dialysis through a previously placed groin catheter, and the only patient history obtained was end stage renal disease and previously failed fistulas and grafts.The cryolife representative attempted to meet with the surgeon to gather more information; however he stated he was too busy to meet with her.A letter was sent to dr.(b)(6) requesting further information, however, as of 12/01/2015 no response has been received.As a lot number was unknown, shipping records were queried for any lot numbers shipped to winthrop university hospital within the past 6 months (03/01/2015 - 09/04/2015) for the hero 1002 device.Two lot numbers were identified in this query, h15av001 and h15av002.The manufacturing records for both lot numbers 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 on (b)(6) 2015.The patient presented post-op with numbness and pain and was diagnosed with steal syndrome.The patient was brought back to surgery the day of implant and the graft was ligated.The patient returned to dialysis through a pre-existing groin catheter.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication.The patient was known to have end stage renal disease and a history of multiple failed fistulas and grafts; additional medical history and intervention/implant operative notes were unavailable.The specific relationship between the hero graft and the reported steal syndrome cannot be assessed at this time without additional information; patient characteristics and surgical technique are possible contributing factors.The root cause for steal syndrome is unknown; however, it is a known complication.The ifu provides the following instructions: "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an id (interior diameter) of at least 3mm to provide adequate arterial inflow to support the graft." "evaluate for steal syndrome during the implant procedure with doppler of the radial and ulnar arteries.If steal syndrome occur, consider surgical interventions such as: dril (distal revascularization-interval ligation) procedure; banding, though this may reduce the flow in the hero graft; proximalization of the inflow." the ifu lists the following potential complication with the use of the hero graft: vascular insufficiency due to steal syndrome.

Event Description

According to the report, "after surgery patient reported numbness in the arm and hand along with severe pain.Surgeon took patient to or and ligated the graft.".

• 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: 5123106
• MDR Text Key: 27300619
• Report Number: 1063481-2015-00236
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• 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; Required Intervention