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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Event Description

A nurse from (b)(6) access team informed the field representative of a hero patient who had a pulmonary embolism.The hero device had not been implanted for long.During a declot procedure performed by the interventional radiologist, the patient had a pe.The patient was too large for imaging, and is currently in the intensive care unit for monitoring.The venous outflow component will likely be removed, but is currently still implanted.As it is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1002 component.

Manufacturer Narrative

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

Manufacturer Narrative

A nurse from (b)(6) dialysis access team informed cryolife of a hero patient who had a pulmonary embolism (pe).The hero device had not been implanted for long.During a declot procedure performed by the interventional radiologist, the patient had a pe.The patient was too large for imaging, and is currently in the intensive care unit for monitoring.The venous outflow component (voc) will likely be removed, but is currently still implanted.Cryolife was unable to gain additional information from the hospital if the voc had in fact been removed.Multiple attempts were made to gain additional information from the hospital, all of which were unsuccessful.According to the available information, a patient experienced a pulmonary embolus during a declot procedure performed by interventional radiology.Embolism is a known potential complication of the hero device.Available clinical information is limited; however, it is implied that the patient is obese which increases the risk of thrombus formation.Other potential risk factors for thrombosis such as pre-existing coagulopathy, smoking, and drug treatment are unknown.The root of the reported event is likely embolization of thrombus from the venous outflow component (voc) dislodged during a thrombectomy procedure.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.This known potential complication is common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

A nurse from (b)(6) dialysis access team informed the field representative of a hero patient who had a pulmonary embolism.The hero device had not been implanted for long.During a declot procedure performed by the interventional radiologist, the patient had a pe.The patient was too large for imaging, and is currently in the intensive care unit for monitoring.The venous outflow component will likely be removed, but is currently still implanted.As it is unknown if either the hero 1001 or hero 1002 contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1002 component.

• 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: 4259453
• MDR Text Key: 4990496
• Report Number: 3006945290-2014-00093
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

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 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• 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): Hospitalization; Other