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

Model Number HERO 1001

Device Problems Occlusion Within Device (1423); Device Dislodged or Dislocated (2923)

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

Event Date 09/27/2010

Event Type  Death  

Event Description

Hemosphere received a call on (b)(6) 2010 that the marker band came off during explant and the patient was coding.The hospital called back later that day and hemosphere was told "the patient had expired.The marker band had lodged in the hepatic vein, but that death was not related to hero device.He said the patient had stents, so that could be what caused the marker band to dislodge.He said the device was being explanted because of repeat occlusion and during thrombectomy on fluoro it appeared the device was disconnected, but during explant realized it was connected with the silicone luer attached." according to the surgeon's office, the patient's implant date was (b)(6) 2010 as an emergency case.It was confirmed the patient had multiple co-morbidities, including stents.Operative notes from implant and a death summary were requested, but not received as the surgeon would not allow release of patient records without patient's consent, which could not be provided since the patient had expired.

Manufacturer Narrative

During a review of records, and out of an abundance of caution, it was determined that a mdr report was required and would be filed for this reported event.Hemosphere received a call on (b)(4) 2010 that the marker band came off during explant and the patient was coding.The hospital called back later that day and hemosphere was told "the patient had expired.The marker band had lodged in the hepatic vein, but that death was not related to hero device.He said the patient had stents, so that could be what caused the marker band to dislodge.He said the device was being explanted because of repeat occlusion and during thrombectomy on fluoro it appeared the device was disconnected, but during explant realized it was connected with the silicone luer attached." according to the surgeon's office, the patient's implant date was (b)(6) 2010 as an emergency case.It was confirmed the patient had multiple co-morbidities, including stents.Operative notes from implant and a death summary were requested, but not received as the surgeon would not allow release of patient records without patient's consent, which could not be provided since the patient had expired.The device was implanted for approximately seven months.The hero outflow component (oc) was returned to hemosphere; the oc still had the luer end but was missing the marker band.There were no missing pieces of silicone at the tip.There were small cuts that may be where a stent poked into the oc right in close proximity to the marker band.There was no indication of thrombus in the oc and there was no damage to the outer silicone coating.The conclusion of the device examination was the device was improperly implanted (with luer end) and not carefully removed with marker band embolization occurring.A review was performed of the available information.The device returned indicated the device was not implanted correctly with luer end attached; however, the device was still attached and functioning at time of explant.During explant, the marker band came off device most likely due to becoming snagged on patient's stent.The patient coded and died.The marker band coming off in the patient was probably not related to the patient's death, since blood can pass through the open lumen.The most likely cause of death was the patient's co-morbidities and not device since device had worked for seven months and had not become disconnected.Furthermore, the dislodged marker band was in a vein in the liver and not in the lung.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HEMOSPHERE, INC.; 6545 city west pkwy.; eden prairie MN 55344
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4423185
• MDR Text Key: 21240059
• Report Number: 1063481-2015-00001
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date: 09/27/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2010
• Was Device Evaluated by Manufacturer?: Yes
• 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