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

Model Number HERO 1003

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombus (2101)

Event Date 01/16/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the report, an (b)(6) old female patient with several co-morbidities coded during a hero implant and later expired.The surgeon began the case by performing a venogram from the groin.Thrombus was not noted, so the hero placement continued.The surgeon wired through an existing dialysis catheter, which was removed for the hero placement.With a stiff amplatz wire in place, the surgeon dilated up and tried advancing the 20 french (fr) sheath.There was resistance in advancing the sheath/dilator, so it was removed and the 12 fr/16 fr dilators were used again.Once again an attempt was made to advance the 20 fr sheath.The patient then coded.The patient was stabilized and taken to the icu where the patient coded again and subsequently expired.No obvious bleeding was present, and the entire procedure was performed under fluoroscopy.The hero venous outflow and arterial components were never opened.

Event Description

According to the report, (b)(6) female patient with several co-morbidities coded during a hero implant and later expired.The surgeon began the case by performing a venogram from the groin.Thrombus was not noted, so the hero placement continued.The surgeon wired through an existing dialysis catheter, which was removed for the hero placement.With a stiff amplatz wire in place, the surgeon dilated up and tried advancing the 20 fr sheath.There was resistance in advancing the sheath/dilator, so it was removed and the 12 fr/16 fr dilators were used again.Once again an attempt was made to advance the 20 fr sheath.The patient then coded.The patient was stabilized and taken to the icu where the patient coded again and subsequently expired.No obvious bleeding was present, and the entire procedure was performed under fluoroscopy.The hero venous outflow and arterial components were never opened.

Manufacturer Narrative

(b)(4).The report states that the patient experienced cardiac arrest during the surgical procedure to implant a hero device.The event occurred while the surgeon was attempting to dilate the insertion site using the dilator provided in the hero accessory kit.The actual hero device was never unpackaged.It does not appear that the dilators caused vascular injury or contributed to the cardiac arrest.The surgeon stated that the death may have been related to an air embolus or thrombus.However, a preprocedure venogram showed no evidence of thrombus.Since an autopsy was not preformed it is not possible to determine the exact cause of death.Embolus and death are known potential interoperative and postoperative complications noted in the instructions for use.It was noted that the patient had several co-morbidities, which likely placed her at an increased risk for intraoperative complications.The age and multiple comorbidities in this patient place her at a significantly greater risk for complications.

• 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: 3600613
• MDR Text Key: 15873085
• Report Number: 3006945290-2014-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2014

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 1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2014
• 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
• Patient Age: 85 YR