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

Model Number HERO 1001

Device Problem Complete Blockage (1094)

Patient Problems Hyperplasia (1906); Thrombosis (2100)

Event Date 04/11/2015

Event Type  Injury  

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 third of four patients.According to the surgeons, "the fourth patient that received revision was a (b)(6) man.The initial operation was on [(b)(6) 2015], [lot numbers] hero 1001 h14vc051, [hero] 1002 h14av015, [hero] 1003 h14ak016.The revision was performed on [(b)(6) 2015].The cause was graft thrombosis.We were again left with the impression that the intimal hyperplasia at the titanium connector had caused the thrombosis." this medwatch report is submitted for hero 1001; however, all lots were investigated.The manufacturing records for lots h14vc051, h14av015, and h14ak016 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 third of four patients.According to the surgeons, "the fourth patient that received revision was a (b)(6) man.The initial operation was on [(b)(6) 2015], [lot numbers] hero 1001 h14vc051, [hero] 1002 h14av015, [hero] 1003 h14ak016.The revision was performed on [(b)(6) 2015].The cause was graft thrombosis.We were again left with the impression that the intimal hyperplasia at the titanium connector had caused the thrombosis." this medwatch report is submitted for hero 1001; however, all lots 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: 5017546
• MDR Text Key: 23532853
• Report Number: 1063481-2015-00171
• 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: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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: H14VC051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• 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): Hospitalization; Other
• Patient Age: 60 YR