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

Model Number HERO 1001

Device Problems Complete Blockage (1094); Occlusion Within Device (1423)

Patient Problems Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

According to the notification form received on 9th of july 2015 a cryolife representative was copied in an email from mr.(b)(6) to another surgeon which described mr.(b)(6) experience of the hero to date.Within that email the surgeon mentions that all the patients so far all have 6 months latency and one is over 1 year."the remaining" had few successful thrombectomies.He also mentions that he had to change the graft segment of one of them recently.

Manufacturer Narrative

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

Manufacturer Narrative

According to the notification form received on 9th of july 2015 a cryolife representative was copied in an email from mr.(b)(6) to another surgeon which described mr.(b)(6) experience of the hero to date.Within that email the surgeon mentions that all the patients so far all have 6 months patency and one is over 1 year."the remaining" had few successful thrombectomies.He also mentions that he had to change the graft segment of one of them recently.Although this medwatch is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to gather additional information from the surgeon; however, all attempts were unsuccessful.Lot numbers could not be determined as dates of implant were not known.A review was performed of the available information.This is a case of patients who required a thrombectomy at some point following hero graft implant.One patient required the surgeon to "change the graft segment." it is unclear if the graft revision was due to occlusion.Thrombosis is the most common cause of vascular access dysfunction; partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero instructions for use (ifu).The following information was not reported for these cases: implant or intervention operative notes, patient history, dialysis compliance, and medication history.Individual risk of thrombosis events cannot be considered without additional information.Certain risk factors, such as missed hemodialysis sessions, can significantly increase the number of thrombosis episodes in arteriovenous fistulas (avfs) and arteriovenous grafts (avgs).Additionally, hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increase risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.At this time, the specific relationship between the hero graft and the reported thrombectomies cannot be assessed with additional information.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.The ifu states "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication" and "utilizing a standard vessel loop, expose the artery and verify the internal diameter (id) is greater than 3mm in size.Verify patency via doppler or tactile feel.Use of the hero graft was clinically studied utilizing the brachial artery.Arterial implantation of the device to other arteries has not been studied and may increase the risk of adverse events not encountered in the clinical trial.However, identification of an alternative artery with an if of 3mm or greater may result in improved blood flow compared to a brachial artery with an if of less than 3mm." the root cause for the reported event is unknown; however, thrombosis and graft revision are known potential complications of the hero graft.

Event Description

According to the notification form received on 9th of july 2015 a cryolife representative was copied in an email from mr.(b)(6) to another surgeon which described mr.(b)(6) experience of the hero to date.Within that email the surgeon mentions that all the patients so far all have 6 months patency and one is over 1 year."the remaining" had few successful thrombectomies.He also mentions that he had to change the graft segment of one of them recently.Although this medwatch is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were 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: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4919482
• MDR Text Key: 6026695
• Report Number: 1063481-2015-00113
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2015

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 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• 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