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

Model Number HERO 1002

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415)

Event Type  Injury  

Event Description

According to the publication, "report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions", four hero grafts, all women, required ligation and explant for severe steal syndrome.All patients had at least a faintly palpable radial pulse preoperatively.All had evidence of significant arterial disease, with one patient having had a previous below knee amputation; one had a completely occluded contralateral brachial artery, one had required coronary revascularization before age 40, and the last had an extensive arterial and venous occlusive history.Three patients had severe pain and motor dysfunction in thee dominant arm in the postoperative recovery area and desired immediate graft removal rather than revision.The remaining patient underwent hero banding and brachial and ulnar artery angioplasty in attempts to treat the symptoms of finger numbness, but without success.Her graft was removed on postoperative day 8.

Manufacturer Narrative

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

Manufacturer Narrative

According to the publication, report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions, four hero grafts, all women, required ligation and explant for severe steal syndrome.All patients had at least a faintly palpable radial pulse preoperatively.All had evidence of significant arterial disease, with one patient having had a previous below knee amputation; one had a completely occluded contralateral brachial artery, one had required coronary revascularization before age 40, and the last had an extensive arterial and venous occlusive history.Three patients had severe pain and motor dysfunction in the dominant arm in the postoperative recovery area and desired immediate graft removal rather than revision.The remaining patient underwent hero banding and brachial and ulnar artery angioplasty in attempts to treat the symptoms of finger numbness, but without success.Her graft was removed on postoperative day 8.Multiple attempts were made to gain additional information from dr.(b)(6), one of the co-authors; however, all attempts were unsuccessful.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges for 2.6% to 3.85% with hero, and 3.8% in arteriovenous grafts (avg).Steal syndrome is not unique to hero graft and is well known complication of arteriovenous access conduits: fistula, prosthetic, biologic and xenograft inclusive.A proximalization of the arterial anastomosis, a banding procedure or an explant are all well established treatments to relieve the teal syndrome as was done in this situation.According to the report, the patients developed steal syndrome after implant of a hero device.Steal syndrome is a known complication of the hero device caused by shunting of arterial blood into the venous system.This complication does not reflect a defect in the device itself.Adequate precautions are provided in the ifu.The root cause for the reported event is excessive shunting of arterial blood into the venous circulation.This event represents known potential complications of the hero graft which are outlined in the device's ifu.This known potential complications are common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the publication, "report on the hemodialysis reliable outflow (hero) experience in dialysis patients with central venous occlusions", four hero grafts, all women, required ligation and explant for severe steal syndrome.All patients had at least a faintly palpable radial pulse preoperatively.All had evidence of significant arterial disease, with one patient having had a previous below knee amputation; one had a completely occluded contralateral brachial artery, one had required coronary revascularization before age 40, and the last had an extensive arterial and venous occlusive history.Three patients had severe pain and motor dysfunction in thee dominant arm in the postoperative recovery area and desired immediate graft removal rather than revision.The remaining patient underwent hero banding and brachial and ulnar artery angioplasty in attempts to treat the symptoms of finger numbness, but without success.Her graft was removed on postoperative day 8.

• 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: 4495770
• MDR Text Key: 16993090
• Report Number: 1063481-2015-00017
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• 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