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

Model Number HERO 1001

Device Problems Complete Blockage (1094); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperplasia (1906); Thrombosis (2100); No Information (3190)

Event Date 01/03/2015

Event Type  Injury  

Event Description

According to the field assurance notification form, "only heard information that there had been 3 revisions on patients who previously received a hero graft.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the first of four patients.According to the surgeons, "the first patient that received the hero graft was a (b)(6) year old woman, [lot numbers] hero 1001 h14vc041, [hero] 1002 h14av015, [hero] 1003 h14ak005.Implantation was performed on the (b)(6) 2014 [(b)(6) 2014], the first revision for graft thrombosis was on (b)(6) 2015 [(b)(6) 2015], the second also for graft thrombosis on (b)(6) 2015 [(b)(6) 2015].It is our impression that the thrombosis was due to intimal hyperplasia at the titanium connector between the eptfe prosthesis and the venous outflow component of the hero graft." this medwatch is submitted for product code hero 1001; however, all product codes were investigated.The manufacturing records for lots h14vc041, h14av015, and h14ak005 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.At this time, the role of the hero graft in these revisions cannot be determined with the available information, although graft revision/replacement is an established treatment for arteriovenous (av) graft complications.Thrombosis is the most common cause of vascular access dysfunction.Thrombosis is a known potential complication of the hero graft and adequate precautions and warnings are provided in the instructions for use (ifu).The risk of thrombosis is influenced by compliance with hemodialysis schedule and patient medical history.For example, hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Medical history was not available for these cases of thrombosis/revision.For these 4 cases of thrombosis in 3 patients, the surgeon believed the thrombosis was "due to intimal hyperplasia at the titanium connector." operative notes for the original hero implant procedures and the revisions were not available; details on the exact revision performed in each case are therefore unknown.Samples were also not received and it cannot be determined if intimal hyperplasia was the cause of the thrombosis events.At this time, the cause of the intimal hyperplasia and the following thrombosis events are unknown as the details of the cases are largely unavailable.

Event Description

According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the first of four patients.According to the surgeons, "the first patient that received the hero graft was a (b)(6) year old woman, [lot numbers] hero 1001 h14vc041, [hero] 1002 h14av015, [hero] 1003 h14ak005.Implantation was performed on the (b)(6) 2014 [(b)(6) 2014], the first revision for graft thrombosis was on (b)(6) 2015 [(b)(6) 2015], the second also for graft thrombosis on (b)(6) 2015 [(b)(6) 2015].It is our impression that the thrombosis was due to intimal hyperplasia at the titanium connector between the eptfe prosthesis and the venous outflow component of the hero graft." this medwatch is submitted for product code hero 1001; however, all product codes 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: 4884773
• MDR Text Key: 6063689
• Report Number: 1063481-2015-00104
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: H14VC041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR