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

Model Number HERO 1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Injury  

Event Description

A hero patient died.As it is unknown wether hero 1001 or hero 1002 contributed to the event, out of caution, both product codes are being investigated.This medwatch is for product code hero 1001.

Manufacturer Narrative

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

Manufacturer Narrative

Description of event, the field representative spoke to the implanting surgeon.The surgeon said that the patient had steal syndrome two weeks out and the hero graft was explanted immediately.The information above which was received from dr.(b)(6) is the more reliable information.The information, which was received from (b)(6), is from an unknown source and would have had to go through a translator.At this time the complaint files are moving forward with the information above." manufacturer narrative: from the additional information it is known that the event is attributed to product code hero 1002 and hero 1001 no longer needs to be investigated.Thus at this time the investigation of hero 1001 for this complaint will cease.The investigation of hero 1002 is on going.

Event Description

The field representative spoke to the implanting surgeon.The surgeon said that the patient had steal syndrome two weeks out and the hero graft was explanted immediately.The the information above which was received from dr.(b)(6) is the more reliable information.The information, which was received from (b)(6), is from an unknown source and would have had to go through a translator.At this time the complaint files are moving forward with the information above.From the additional information it is known that the event is attributed to product code hero 1002 and hero 1001 no longer needs to be investigated.Thus at this time the investigation of hero 1001 for this complaint will cease.

• 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: 4268576
• MDR Text Key: 5225788
• Report Number: 3006945290-2014-00098
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 11/21/2014
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death