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

Model Number HERO 1001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

According to the journal article, hero- the last resort measure- single center series and review of literature, a (b)(6) patient who had been on dialysis for 2 years received a hero graft on (b)(6) 2014 due to bilateral central vein occlusion.The patient has had 3 previous surgeries and a bmi of 53.The hero was placed in the left internal jugular vein.The hero graft migraft to the superior vena cava (svc).An attempt to advance the hero to the right atrium failed due to severe fibrotic central vein stenosis.The hero was removed.

Manufacturer Narrative

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

Manufacturer Narrative

According to the journal article, hero- the last measure - single center series and review of literature, a (b)(6) patient who had been on dialysis for 2 years received a hero graft on (b)(6) 2014 due to bilateral central vein occlusion.The patient has had 3 previous surgeries and a bmi of (b)(6).The hero was placed in the left internal jugular vein.The hero graft migrated to the superior vena cava (svc).An attempt to advance the hero to the right atrium failed due to severe fibrotic central vein stenosis.The hero was removed.This patient is also discussed in the case study, catheter-directed thrombolysis in acute superior vena cava syndrome caused by central venous catheters.The case study gives additional information of the patient's co-morbidities along with access history.The patient followed up in a clinic 10 days after receiving the hero device and reported a pounding headache, dizziness, palpitation, and facial swelling.Chest x-ray showed that the tip of the hero graft was against wall of the svc.A clinical diagnosis of acute superior vena cava syndrome (svcs) was made and the patient was admitted.The hero graft was removed the next day.Possible lot numbers were identified and reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record device migration is listed on the hero graft instructions for use (ifu) as a potential vascular graft and catheter complication.Directions on how to place the device are provided in the ifu.Without operative notes or further details about device placement it is not clear how this event occurred and if there were any surgical deviations from the specified methodology.Superior vena cava (svc) syndrome is listed as a potential vascular graft and catheter complication on the ifu.The symptoms reported on the clinic presentation, including headache, dizziness, palpitation, and facial swelling, are known symptoms of superior vena cava (svc) syndrome.The attempt to advance the device into the right atrium was an appropriate course of action to salvage the device and regain access.After failure to access the right atrium, the decision to explant was appropriate given the patient history of access challenges.Superior vena cava syndrome and device migration are known potential complications which are outlined in the device's ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the journal article, hero- the last resort measure- single center series and review of literature, a (b)(6) patient who had been on dialysis for 2 years received a hero graft on (b)(6) 2014 due to bilateral central vein occlusion.The patient has had 3 previous surgeries and a bmi of (b)(6).The hero was placed in the left internal jugular vein.The hero graft migraft to the superior vena cava (svc).An attempt to advance the hero to the right atrium failed due to severe fibrotic central vein stenosis.The hero was removed.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• 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: 4690732
• MDR Text Key: 5651134
• Report Number: 1063481-2015-00043
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• 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
• Patient Age: 28 YR