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

Model Number HERO 1001

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, the patient had a surgical revision of the hero graft.Additional information indicated that the revision was to shorten the hero outflow catheter and reposition it one year after conversion for salvage of standard arteriovenous graft to hero.

Manufacturer Narrative

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

Manufacturer Narrative

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, the patient had a surgical revision of the hero graft.Additional information indicated that the revision was to shorten the hero outflow catheter and reposition it one year after conversion for salvage of standard arteriovenous graft to hero.The manufacturing records for lot 0001512 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The instructions for use lists device migration and vascular graft revision/replacement as a potential complication with the use of the hero graft.A review of the manufacturing records has been performed.There is no indication that an error or deficiency occurred at cryolife.

Event Description

According to a manuscript, the end stage of dialysis access: femoral graft or hero vascular access device, the patient had a surgical revision of the hero graft.Additional information indicated that the revision was to shorten the hero outflow catheter and reposition it one year after conversion for salvage of standard arteriovenous graft to hero.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4178695
• MDR Text Key: 15328388
• Report Number: 3006945290-2014-00078
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0001512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• 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): Other