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

Model Number HERO 1002

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

Patient Problem Pulmonary Embolism (1498)

Event Date 10/10/2014

Event Type  Death  

Event Description

According to the report, the patient had a pulmonary embolism.As it is unknown whether 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 1002.

Manufacturer Narrative

According to the report, the patient had a pulmonary embolism.As it is unknown whether 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 1002.Attempts were made to request additional information on (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2015, (b)(6) /2015, (b)(6) 2015, and (b)(6) 2015.The only additional information that was received was that the hero surgery took place on (b)(6) 2014, the pulmonary embolism occurred on (b)(6) 2014, the patient received intravenous (iv) systemic tissue plasminogen activator (tpa) lysis, recovered, and was discharged home on (b)(6) 2014.The information indicated that the patient "died one month ago," which would have placed the date of death approximately (b)(6) 2014.No further information was received as to the exact date of death or whether the death was related to the hero device.The manufacturing records for the possible lot numbers were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.The hero graft instructions for use (ifu) indicate the graft may need maintenance due to thrombus and refers to the thrombectomy guidelines for additional information.The thrombectomy guidelines suggests removing clot from the venous portion before removing the arterial plug to reduce the patient's risk for developing pulmonary embolism (pe).The ifu also lists pe and/or death as potential adverse events.Table 2 of the ifu shows rates of 1.9% - 2.6% for pe and 0% - 1.9% for death.Additionally, the post-market retrospective multi-center study of 164 patients, gage, et al.Reported 29 deaths (17%) during a mean follow-up period of 15.4 months.The authors attributed the observed death rate to "the extreme morbidity of the end stage vascular access patients with central venous pathology." there is insufficient information to determine the source of the pulmonary embolus.Deep venous thrombosis of the pelvis and legs are common sources for pulmonary emboli.Thrombus within the hero graft is another possible source.Pulmonary embolus is a known potential complication of the hero device.Adequate precautions and warnings are provided in the instructions for use.Patient co-morbidities, such as a hypercoagulable state, that may predispose the patient to thrombotic events are unknown.There is insufficient information to determine the root cause for the pulmonary embolus and reported death.The role of the hero device in the reported events cannot be determined.

Event Description

According to the report, the patient had a pulmonary embolism.As it is unknown whether 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 1002.

Manufacturer Narrative

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

• 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: 4296767
• MDR Text Key: 16304318
• Report Number: 3006945290-2014-00102
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

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: 11/14/2014
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2015
• 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): Death; Other