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

Model Number HERO 1001

Device Problems Complete Blockage (1094); Fracture (1260)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 09/03/2015

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, the surgeon "brought this patient into the operating room to replace this patient's original hero 1001 that was about 4-5 years post implant.The surgeon stated this patient was on vacation and his graft clotted and the surgeon decided to replace the hero 1001 with a new hero 1001 was the best option for this patient.When the surgeon explanted the original hero 1001, he noticed that there were some fracturing of the component that he had never seen on other components that he had explanted.".

Manufacturer Narrative

According to the report, the surgeon "brought this patient into the or to replace this patient's original hero 1001 that was about 4-5 years post implant.The surgeon stated this patient was on vacation and his graft clotted and the surgeon decided to replace the hero 1001 with a new hero 1001 was the best option for this patient.When the surgeon explanted the original hero 1001, he noticed that there were some fracturing of the component that he had never seen on other components that he had explanted." the hospital staff discarded the hero 1001 before it could be returned to cryolife for evaluation.Multiple attempts were made to obtain further information.The surgeon called cryolife on (b)(6) 2015 and stated "he originally implanted a hero in this patient on (b)(6) 2010 (lot number is unknown).There were no problems or issues with it until the reported event.The surgeon stated his patient was on vacation out of town and fell causing a head injury.The patient stopped taking his coumadin as a result and a femoral permcath was placed until the patient returned from vacation.Upon the patient returning, the surgeon stated he found the hero to be clotted.He stated he decided to replace the hero 1001 as it had been implanted so long instead of trying any de-clot method.When the hero 1001 was explanted, the surgeon stated he noticed crushing to the component but stated it was the result of placement.He stated the placement was under the clavicle first rib area and it was bone on bone.He also clarified that he used a subclavian approach when he implanted the first hero.He replaced the hero with no issues and stated the patient was doing fine." a review of manufacturing records could not be performed as a lot number for the hero device is unknown.A review was performed of the available information.The patient was implanted with a hero graft on (b)(6) 2010.On (b)(6) 2015 the surgeon replaced the venous outflow component (voc) due to clotting.During replacement the surgeon noted crushing to the voc.This was clarified to mean the crushing resulted from the placement of the voc.Partial stenosis or full occlusion of the 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.In this case the patient had discontinued coumadin and was confirmed to be (b)(6), which may have increased the risk of blood clotting in the hero graft.Alternatively, the crush/damage to the voc may have impaired blood flow, leading to graft thrombosis.The surgeon also chose to implant the graft through the subclavian vein, as opposed to the internal jugular vein.As stated in the ifu, central venous access through other veins, for example, the subclavian vein, has not been studied and may increase risk of adverse events not encountered in the clinical trial.When using the subclavian vein for venous access, a more lateral percutaneous approach might mitigate the risk of clavicle crush or occlusion of the voc.Consideration should be made to follow these patients with clavicle imaging to monitor the potential of interaction of the clavicle and first rib with the voc.Implant/intervention operative notes were not provided.The relationship between the hero graft and the clotting and voc crushing cannot be determined without additional information.Discontinuation of coumadin, history of (b)(6) and voc crushing may have increased the risk of clotting in this patient.Thrombosis/occlusion and device compression are known complications.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 [internal diameter] id of at least 3mm to provide adequate arterial inflow to support the graft," and "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication." the ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature.

Event Description

According to the report, the surgeon "brought this patient into the or to replace this patient's original hero 1001 that was about 4-5 years post implant.The surgeon stated this patient was on vacation and his graft clotted and the surgeon decided to replace the hero 1001 with a new hero 1001 was the best option for this patient.When the surgeon explanted the original hero 1001, he noticed that there were some fracturing of the component that he had never seen on other components that he had explanted.".

• 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: 5116130
• MDR Text Key: 27203360
• Report Number: 1063481-2015-00234
• 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: 09/03/2015

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 1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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