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

Model Number HERO 1001

Device Problems Difficult or Delayed Positioning (1157); Kinked (1339)

Patient Problem No Information (3190)

Event Date 01/28/2014

Event Type  Injury  

Event Description

According to the report, the surgeon was attempting a subclavian route to place the voc.The surgeon was having difficulty and placed three viabond stents.The surgeon continued to have difficulty and complained the voc was defective as it kept kinking.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, the surgeon was attempting a subclavian route to place the hero graft venous outflow component (voc).The surgeon was having difficulty and placed three viabahn stents.The surgeon continued to have difficulty and complained the voc was defective as it kept kinking.On 03/11/2014 the cryolife field representative confirmed that the sample would not be returned and added that the hospital's operating room manager and cardiovascular nurse manager do not believe there was a problem with the voc.They told her that this surgeon historically gets frustrated and will claim product problem when there is none.Several attempts were made to contact the surgeon for additional information regarding this event: two phone calls (4/10/2014 and 4/17/2014), three letters (5/1/2014, 7/25/2014, and 7/28/2014), and one fax (7/28/2014).The report does not say which side the implant was placed, but does indicate it was through a subclavian vein which means the voc would need to make a nearly right angle turn to reach the right atrium of the heart.The report also does not indicate if the surgeon lubricated the voc and used a twisting motion as indicated in the hero graft instructions for use (ifu).The ifu has notes that "if resistance is felt, determine the cause before continuing to advance the voc.Keep the sheath straight to prevent it from kinking.If the sheath is bent, remove it and replace with a new short 20f sheath." the ifu lists in the indications for use that hero graft is for patients with compromised central venous system or central venous stenosis (cvs).This patient apparently had severe stenosis since three viabahn stents were required to keep the vessel open enough to place the hero graft voc.The ifu also lists in the general cautions: "caution should be used when placing or removing the voc where stent contact may occur due to the potential for voc or vessel damage.In the opinion of the clinical research department, this event is a known potential complication most likely related to a combination of patient anatomy and physician technique.The manufacturing records were reviewed by quality control and it was confirmed that all records were controlled.Available for review, and met all specifications per the device master record.

Event Description

According to the report, the surgeon was attempting a subclavian route to place the voc.The surgeon was having difficulty and placed three viabond stents.The surgeon continued to have difficulty and complained the voc was defective as it kept kinking.

• 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: 3654199
• MDR Text Key: 4194931
• Report Number: 3006945290-2014-00018
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

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: H13AVC018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2014
• 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