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

Model Number HERO 1001

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Unspecified Infection (1930); Necrosis (1971); Occlusion (1984)

Event Date 10/18/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the initial report, the rep indicated "whilst giving a lecture to a group of neuro surgeons i was told by the reportee that he had used bioglue on three children under 1 yr on spinal dural closure and that he had observed necrosis in all instances and that he had to re-operate in one instance to remove the bioglue.The dates of operations are currently unknown." as three separate patients are involved, each event will be investigated under a separate complaint.This investigation will be relegated to patient 3.

Manufacturer Narrative

According to the report from the representative, the following sequence of events occurred in a hero patient: (b)(6) 2015: patient implanted.(b)(6) : first cannulation w/ 2 needles.(b)(6): emergency admission for vomiting.(b)(6): stroke, one sided.(b)(6): blood culture confirmation of klebsiella.Pt put on antibiotic for 6 wks.(b)(6): hero graft clotted.(b)(6): cvc inserted.(b)(6): thrombectomy by dr.(b)(6).(b)(6): cannulation of hero graft w/ 1 needle.(b)(6): abcess over connector site.(b)(6): patient deceased.Multiple attempts have been made to obtain additional information without success.The following additional information has been requested: stroke etiology, details regarding the positive blood culture, the official cause of death, pertinent patient comorbidities, and progress/operative notes if available.The representative corresponded with the distributor in (b)(4) (and the corresponding surgeon representative) via email on 11/12/2015, spoke with him on 11/24/2015, again on 12/04/2015, and followed with email on 12/07/2015.The distributor indicated on 12/07/2015 that he had spoken with the surgeon on 12/04/2015; the surgeon stated that "he would look at it on the weekend," but a response was never received by the surgeon.If additional clarification is received from the surgeon, the complaint will re-opened to re-evaluate the information in relation to the reported events.The manufacturing records for lots h15vc002 and h15av002 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was implanted with a hero graft on (b)(6) 2015.The graft was first cannulated with two needles on (b)(6) 2015, two days after implant.Based on the available information, it is unclear what type of graft was used during implant.According the hero graft instructions for use (ifu), the arterial graft component (agc) requires 2-4 weeks to incorporate prior to cannulation.The role that the type of graft utilized or the timing of cannulation may have had on the reported events cannot be assessed without additional information.The patient presented to the emergency room on (b)(6) 2015 for vomiting.On (b)(6) 2015 the patient was documented to have a one-sided stroke.The hero graft instructions for use (ifu) report that 0 (0%) patients from the hero graft bacteremia study and 1 (1.9%) patient from the hero graft patency study suffered from stroke during the studies.The following information is not available for any of the reported events: patient medical history, implant/intervention notes, and dialysis information.It is unclear if the patient suffered from a hemorrhagic stroke or an ischemic stroke.The relationship between the hero graft and the patient's stroke cannot be determined with the information provided.On (b)(6) 2015 the patient was documented to have an infection with blood culture results confirming klebsiella.The patient was placed on antibiotics for six weeks.The hero graft ifu lists infection as a potential complication.Infection is a known complication of all prosthetic arteriovenous (av) grafts.The patient selection considerations listed in the hero graft ifu state that the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site infection and cannulation; the graft was cannulated two days post implant.A relationship between the hero graft and the infection cannot be determined with the provided information.On (b)(6) 2015 the patient had a clotted hero graft which was treated with a thrombectomy on (b)(6) 2015.During this time the patient had a central venous catheter (cvc) placed on (b)(6) 2015.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft ifu.Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The relationship between the hero graft and the clotting event cannot be determined with the information provided.On (b)(6) 2015 the patient had an abscess reported over the hero graft connector site.Hero graft cannulation was reinitiated on (b)(6) 2015.There is no additional information available around the time of this event.The following is unclear: source of the abscess, appropriate lab testing results and how it was treated.As previously stated, the hero ifu lists infection as a known complication, as well as abnormal healing.The relationship between the hero graft and the abscess cannot be determined with the information provided.On (b)(6) 2015 the patient died; the cause of death was not reported.The hero graft ifu lists death as a potential intraoperative and post-operative complication; however, the relationship between the hero graft and the patient's death is unknown, as additional information was not provided.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report the following sequence of events occurred in a hero patient: (b)(6) 2015: patient implanted.(b)(6) : first cannulation w/ 2 needles.(b)(6): emergency admission for vomiting.(b)(6): stroke, one sided.(b)(6): blood culture confirmation of klebsiella.Pt put on antibiotic for 6 wks.(b)(6): hero graft clotted.(b)(6): cvc inserted.(b)(6): thrombectomy by dr.(b)(6).(b)(6): cannulation of hero graft w/ 1 needle.(b)(6): abcess over connector site.(b)(6): patient deceased.The scope of the investigation will evaluate both hero 1001 and 1002 components but will be submitted via this report under hero 1001.

• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5214316
• MDR Text Key: 30890360
• Report Number: 1063481-2015-00343
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

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 1001
• Device Lot Number: H15VC002, H15AV002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• 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; Life Threatening; Other