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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

Event Date 08/26/2015

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 received from the cryolife representative, the surgeon "emailed me for information on hero removal.She did not provide any other details of why." additional information was received from the surgeon via the cryolife representative which stated "pt had clotted his hero system several times in last 4 months.After over 4 successful thrombectomy, balloon angioplasty of stenting of part of the outflow graft close to axillary segment of the graft and within the attachment of graft and catheter, i decided that it was time to give up on the hero graft.I am consider putting a new hero system in the same spot but different tunneling configuration in about 3 months.".

Manufacturer Narrative

According to the report received from the cryolife representative, the surgeon "emailed me for information on hero removal.She did not provide any other details of why." additional information was received from the surgeon via the cryolife representative which stated "pt had clotted his hero system several times in last 4 months.After over 4 successful thrombectomy, balloon angioplasty of stenting of part of the outflow graft close to axillary segment of the graft and within the attachment of graft and catheter, i decided that it was time to give up on the hero graft.I am consider putting a new hero system in the same spot but different tunneling configuration in about 3 months." although the report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are investigated.The explanted hero graft device was discarded by the hospital.Multiple attempts were made to obtain additional information, including including lot numbers of the hero graft implanted on (b)(6) 2014, information on tunneling configuration used, dates of thrombectomies, operative notes and imaging, and the patient's current status; however, all attempts were unsuccessful.Shipping records were queried for possible lot numbers shipped to the hospital in the six months prior to the implant date.The manufacturing records for lots h14vc024 and h14av012 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 is a (b)(6) who had a hero graft implanted on (b)(6) 2014.The rep received an e-mail from the vascular surgeon on (b)(6) 2015 inquiring about hero graft explant.In the past 4 months the patient required multiple interventions to treat clotting/thromboses.The interventions included "over 4 successful thrombectomy, balloon angioplasty of stenting of part of the outflow graft close to axillary segment of the graft ad within the attachment of graft and catheter." the surgeon decided that "it was time to give up on the hero graft," but mentioned possibly implanting a replacement hero in the future.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 inadequate maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Additional information, including patient medical history and hero graft implant/intervention notes, was not provided.The specific relationship between the hero graft and the reported thrombosis cannot be assessed at this time without additional information.The root cause of the reported event is unknown.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 provides the following information: "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an id [inner diameter] of at least 3mm to provide adequate arterial inflow to support the graft," "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication," and "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 id of 3mm or greater may result in improved blood flow comparted to a brachial artery with an id of less than 3mm.".

Event Description

According to the report received from the cryolife representative, the surgeon "emailed me for information on hero removal.She did not provide any other details of why." additional information was received from the surgeon via the cryolife representative which stated "pt had clotted his hero system several times in last 4 months.After over 4 successful thrombectomy, balloon angioplasty of stenting of part of the outflow graft close to axillary segment of the graft and within the attachment of graft and catheter, i decided that it was time to give up on the hero graft.I am consider putting a new hero system in the same spot but different tunneling configuration in about 3 months." although the report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 are 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5078455
• MDR Text Key: 25844583
• Report Number: 1063481-2015-00226
• 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: Initial,Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• 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
• Date Manufacturer Received: 08/26/2015
• 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
• Patient Age: 17 YR