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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Event Description

According to the publication, examining hero catheter performance and cost in hemodialysis access, a patient expired after receiving a hero implant.The time period between implant and patient expiration is unknown.

Manufacturer Narrative

According to the publication, examining hero catheter performance and cost in hemodialysis access, a patient expired after receiving a hero implant.The time period between implant and patient expiration is unknown.Upon review of the file it was decided that the complaint should also be investigated also as product code hero 1002.A medwatch was submitted for this event under product code hero 1001 refer to 3006945290-2014-00030.Multiple attempts were made to obtain additional information.However, no additional information was received.A review of this event was performed based on the limited available information.A records review was performed for all lot numbers shipped to the hospital and it was confirmed that all records were controlled, available for review, and met all specifications.The causes of death and relationships to the hero device are unknown.The publication notes that the patients receiving the hero device have been on dialysis for a mean of 7.8 years and had multiple comorbidities including hypertension, diabetes, obesity, and hyperlipidemia, all of which would place the patients at an increased risk of death.There is insufficient information available to determine a root cause of the reported event.The hero graft instructions for use list death as a potential complication.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.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• 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: 4124055
• MDR Text Key: 4943839
• Report Number: 3006945290-2014-00067
• 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
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2014
• 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: 03/17/2014
• 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): Death