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

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

According to a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by inston et al.Implantations (august and october 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The paper identified a minor transient complication, a device repositioning managed as a day case.

Manufacturer Narrative

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

Manufacturer Narrative

According to a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by (b)(6) et al.Implantations ((b)(6) 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The paper identified a minor transient complication, a device repositioning managed as a day case.Multiple attempts were made to gain additional information from mr.(b)(6); however all were unsuccessful.Device migration is listed on the hero graft ifu as a potential vascular graft and catheter complication.Directions on how to place the device are provided in the ifu.Adequate precautions and warnings are provided in the ifu.Without operative notes or farther details about the device repositioning it is not clear how this event occurred and if there were any surgical deviations from the specified methodology.It is unclear what impact this event had on the patient.The case was treated within the span of one day, but the intervention used to treat the patient is unclear.The root cause for the reported event is unknown.Device migration is listed on the hero graft ifu as a potential vascular graft and catheter complication.Directions on how to place the device are provided in the ifu.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to a poster presentation entitled, "the hemodialysis reliable outflow (hero) graft: a cost-consequence analysis, and patient case series" by inston et al.Implantations ((b)(6) 2013) for three patients with end stage failing vascular access, aged 39 to 51 years and with 6 to 13 previous catheter lines, were reviewed retrospectively.The paper identified a minor transient complication, a device repositioning managed as a day case.

• 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: 4733707
• MDR Text Key: 5751314
• Report Number: 1063481-2015-00055
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• 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; Required Intervention