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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

According to the published paper "outcomes comparison of hero and lower extremity arteriovenous grafts in patients with long-standing renal failure," one hero patient developed upper extremity steal syndrome following hero insertion and was treated on the first postoperative day with a 4-mm eptfe interposition at the arterial anastomosis.

Manufacturer Narrative

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

Manufacturer Narrative

According to the published paper "outcomes comparison of hero and lower extremity arteriovenous grafts in patients with long-standing renal failure," one hero patient developed upper extremity steal syndrome following hero insertion and was treated on the first postoperative day with a 4-mm eptfe interposition at the arterial anastomosis.Additional information regarding the hero patient was requested on 04/15/2015 from the leading author of the publication.The specific information requested included the following: date of implant, date of steal syndrome, success of the intervention, patient comorbidities, current status of the patient, and the lot number.The surgeon replied on 04/26/2015 stating, "i've been trying to find some of the data, however with the study being completed 3 years ago i haven't had any success.In addition, after data collection, the database was de-identified in standard fashion.With my involvement being so long ago, i'm afraid i can't recall any of the specifics that you're asking." a manufacturing record review could not be performed as lot numbers were unavailable.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero and 3.8% in other arteriovenous grafts (avgs).Steal syndrome is not unique to the hero graft and is a well-known complication of arteriovenous access conduits; fistula, prosthetic, biologic, and xenograft inclusive.Banding procedures are well established treatments to relieve steal syndrome, as was done in this situation.Steal syndrome is a known complication of the hero device caused by shunting of blood into the venous system.This complication does not reflect a defect in the device itself and adequate precautions are provided in the ifu.

Event Description

According to the published paper "outcomes comparison of hero and lower extremity arteriovenous grafts in patients with long-standing renal failure," one hero patient developed upper extremity steal syndrome following hero insertion and was treated on the first postoperative day with a 4-mm eptfe interposition at the arterial anastomosis.This mdr is being filed under hero 1002.

• 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: 4694688
• MDR Text Key: 16864631
• Report Number: 1063481-2015-00047
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• 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