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

Model Number HERO 1001

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 05/12/2015

Event Type  Injury  

Event Description

According to the phone call received from the cryolife representative, who was present for the procedure, the guidewire and the hero voc breached the patient's svc and "got outside the vein." that caused a bleed which could not be repaired during the implant.The case was halted and the patient was moved to cardiac.The patient's blood pressure dropped so low that chest compressions and cpr were necessary, but the patient did not flatline.The patient was placed on full bypass while the chest was opened to repair the tear.Dan stayed until the patient stabilized.The hero was removed and discarded.The surgeon stated that it was "hard to push through the outflow component," so he was not sure where it was going.

Manufacturer Narrative

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

Manufacturer Narrative

According to the notification form, the guidewire and the hero breached the patient's superior vena cava (svc) and "got outside the vein." that caused a bleed which could not be repaired during the implant.The case was halted and the patient was removed to cardiac.The patient's blood pressure dropped so low that chest compressions and cpr were necessary, but the patient did not flatline.The patient was placed on full bypass while the chest was opened to repair the tear.The representative stayed until the patient stabilized.The hero was removed and discarded.The surgeon stated that it was "hard to push through the outflow component," so he was not sure where it was going.\ multiple attempts have been made to gain additional information from the complainant; however all have been unsuccessful.2 possible lot numbers were determined from shipping records.Manufacturing records for lots h15vc005 and h14ak014 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Detailed directions for implanting the venous outflow component (voc), gaining venous access, and advancing the voc into the superior vena cava (svc) are provided in the hero graft instructions for use (ifu).It is not clear whether or not the surgeon used the internal jugular vein for access into the svc; central venous access through any other vein has not been studied and therefore the type and frequency of adverse events are currently unknown.Bleeding and trauma to major vasculature or nerves are listed in the ifu as potential intraoperative and post-operative complications.Appropriate actions to treat the bleed and abandon the device implantation were taken.With the limited information available, it is not possible to determine the specific relationship between the event and the hero graft implant procedure; the surgeon was unable to provide additional clarifying information regarding the alleged event.Patient history is unknown and risk factors for bleeding cannot be assessed at this time.According to the limited information, the svc was breached during implantation of the voc requiring open surgical repair.Limited information is available; however the surgeon stated that it was "hard to push through the outflow component." this statement implies significant stenosis of the svc was likely.Although the precise cause of the event is unknown, it is possible that the guidewire perforated the svc.The voc may have then followed the guidewire through the defect in the svc wall.The ifu states "if resistance is felt, determine the cause before continuing to advance the venous outflow component." adequate precautions and warnings regarding resistance to voc placement are provided in the ifu.Limited information is available about the events and a definitive root cause could not be determined.The ifu states "if resistance is felt, determine the cause before continuing to advance the venous outflow component." the ifu also lists the following as a potential complication with the use of the hero graft: "trauma to major vasculature or nerves." 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 phone call received from the cryolife representative, who was present for the procedure, the guidewire and the hero voc breached the patient's svc and "got outside the vein." that caused a bleed which could not be repaired during the implant.The case was halted and the patient was moved to cardiac.The patient's blood pressure dropped so low that chest compressions and cpr were necessary, but the patient did not flatline.The patient was placed on full bypass while the chest was opened to repair the tear.Dan stayed until the patient stabilized.The hero was removed and discarded.The surgeon stated that it was "hard to push through the outflow component," so he was not sure where it was going.Hero 1001 and hero 1003 were investigated as potentially attributing to the complaint.

• 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: 4777380
• MDR Text Key: 21082323
• Report Number: 1063481-2015-00064
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H15VC005; H14AK014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• 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; Required Intervention