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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

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 of a 2014 presentation, a male patient, approximately (b)(6)-old and caucasian, completely occluded but was able to be cleaned and restored for continued dialysis receipt via hero graft.The complainant confirmed two successful dialysis treatments after procedure.

Manufacturer Narrative

According to the report of an october 2014 presentation, a male patient, approximately (b)(6) and caucasian, completely occluded but was able to be cleaned and restored for continued dialysis receipt via hero graft.The complainant confirmed two successful dialysis treatments after procedure.Although this report is filed for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to obtain additional information regarding patient co-morbidities and/or operative notes for each case, when the occlusion was first noticed in the patient, how quickly after implant the occlusion occurred, and lot numbers of the implanted hero grafts; however, all attempts were unsuccessful.A review of manufacturing records could not be performed as lot numbers for the hero devices are unknown.The dates of implant and hospital where the implant occurred are unknown; therefore, shipping records could not be queried for possible lot numbers shipped to the hospital.A review was performed of the available information.A hero graft patient was reported to have occlusions in (b)(6) 2014.The graft was "completely occluded, but able to be cleaned and restored for continued dialysis receipt." 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 inadequately 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 occlusions cannot be assessed at this time without additional information.Occlusion is a known potential complication of the hero graft.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 states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft." the ifu also states "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication.".

Event Description

According to the report of an (b)(6) 2014 presentation, a male patient, approximately (b)(6) and caucasian, completely occluded but was able to be cleaned and restored for continued dialysis receipt via hero graft.The complainant confirmed two successful dialysis treatments after procedure.Although this report is filed for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.

Manufacturer Narrative

According to the report of a (b)(6) 2015 presentation, a male patient, approximately (b)(6)and caucasian, completely occluded but was able to be cleaned and restored for continued dialysis receipt via hero graft.The complainant confirmed two successful dialysis treatments after procedure.Although this report is filed for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.Multiple attempts were made to obtain additional information regarding patient co-morbidities and/or operative notes for each case, when the occlusion was first noticed in the patient, how quickly after implant the occlusion occurred, and lot numbers of the implanted hero grafts; however, all attempts were unsuccessful.A review of manufacturing records could not be performed as lot numbers for the hero devices are unknown.The dates of implant and hospital where the implant occurred are unknown; therefore, shipping records could not be queried for possible lot numbers shipped to the hospital.A review was performed of the available information.A hero graft patient was reported to have occlusions in (b)(6) of 2015.The graft was "completely occluded, but able to be cleaned and restored for continued dialysis receipt." 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 inadequately 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 occlusions cannot be assessed at this time without additional information.Occlusion is a known potential complication of the hero graft.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 states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft." the ifu also states "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication.".

Event Description

According to the report of a (b)(6) 2015 presentation, a male patient, approximately (b)(6) and caucasian, completely occluded but was able to be cleaned and restored for continued dialysis receipt via hero graft.The complainant confirmed two successful dialysis treatments after procedure.Although this report is filed 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: 5031185
• MDR Text Key: 24070065
• Report Number: 1063481-2015-00200
• 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: health professional,study
• Reporter Occupation: Physician
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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: 07/27/2015
• 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
• Patient Age: 40 YR