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

Model Number HERO 1001

Device Problem Difficult to Insert (1316)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Scar Tissue (2060); Swelling (2091); Therapeutic Effects, Unexpected (2099); Thrombosis (2100)

Event Date 05/11/2015

Event Type  Injury  

Event Description

According to the report, the patient has bartter's syndrome and had a previous hero graft that was implanted two years ago and not getting adequate dialysis due to clotting.The surgeon implanted a new hero graft on the patient's ipsilateral arm as the previous hero graft access.The patient had a significant drop in blood pressure during surgery and they "just about lost her." the surgeon said that he had a difficult time implanting the hero graft "through all the scar tissue." the patient has been discharged and getting dialysis through the tunneled dialysis catheter.The patient's arm where the hero graft was implanted was swollen twice the size of the normal arm.Instead of the hero graft procedure being an outpatient procedure, the patient was admitted and stayed in the hospital for 3 to 4 days due to the swelling.The patient experienced arm pain.The surgeon discharged the patient with a dialysis catheter in the neck region and said that the hero graft could not be accessed for 6 months.The surgeon was asked the reason for the 6 months waiting time, but he did not provide an answer.This report is for both the hero 1001 and hero 1002 device.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Manufacturer Narrative

According to the report, the patient has bartter's syndrome and had a previous hero graft that was implanted two years ago and not getting adequate dialysis due to clotting.The surgeon implanted a new hero graft on the patient's ipsilateral arm as the previous hero graft access.The patient had a significant drop in blood pressure during surgery and they "just about lost her." the surgeon said that he had a difficult time implanting the hero graft "through all the scar tissue." the patient has been discharged and getting dialysis through the tunneled dialysis catheter.The patient's arm where the hero graft was implanted was swollen twice the size of the normal arm.Instead of the hero graft procedure being an outpatient procedure, the patient was admitted and stayed in the hospital for 3 to 4 days due to the swelling.The patient experienced arm pain.The surgeon discharged the patient with a dialysis catheter in the neck region and said that the hero graft could not be accessed for 6 months.The surgeon was asked the reason for the 6 months waiting time, but he did not provide an answer.This report is for both the hero 1001 and hero 1002 device.Additional information was received on 5/21/2015 from a cryolife marketing representative regarding a phone conversation that he had with the complainant on the same day.The complainant reported that her niece was experiencing further swelling in the arm where the second hero graft was implanted.In her words, "it is as big around as a (b)(6) coffee can." she also commented that the implanting surgeon was aware of the swelling.Additionally, a voicemail from the complainant was received on 06/04/2015 that stated, "last month my niece (b)(6) had another hero catheter inserted into the right arm where the first one is.I sent an email to (b)(6) and am waiting on a reply.We are wondering if the first hero catheter should have been left in her arm.Her arm is severely infected and she is in the hospital again and the surgeon told us that the old catheter is filled with quite a lot of blood.We are wondering if that should be removed, the surgeon doesn't seem too sure about it." additional information was requested from the surgeon on 05/21/2015, 06/02/2015, and 06/08/2015 without success.A review of manufacturing records was not requested as lot numbers for the hero device are unknown.The event notification form indicated a date of incident was (b)(6) 2015, however, it could not definitively be determined what occurred on this date.Therefore, shipping records could not be queried for possible lot numbers shipped to the hospital.The hero graft ifu lists partial stenosis or full occlusion of prosthesis or vasculature as a potential vascular graft and catheter complication.In this case, the surgeon treated the clotting of the original hero graft with a graft revision to reinitiate vascular patency.The patient's prior history of interventions and/or clotting is unknown.The ifu also lists edema and site pain as potential vascular graft and catheter complications.The arm swelling and pain in this patient may have been related to the implant procedure, which was described as "difficult" due to "all the scar tissue." surgical notes from the procedure were not available.At this time, a relationship between the hero graft and the swelling and pain cannot be determined.As stated in the hero ifu, vascular access cannulation should not begin until swelling subsides enough to allow palpation of the entire arterial graft component (agc).The ifu also states that the hero graft requires 2-4 weeks to incorporate prior to cannulation.It is unclear why the surgeon wanted to wait 6 months, as this information was not available.The hero ifu also lists infection as a potential complication.The patient selection considerations listed in the ifu states 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.The source of the patient's infection is unknown and it is unclear if the infection was related to the surgical site and presented as a local or systemic infection.It is also unclear when the infection was first diagnosed, what type of infection was present, patient history of infection, and what treatment was delivered to address the problem.As indicated in the ifu, removal of the bridging catheter as soon as possible is suggested to decrease the risk of infection related to the bridging catheter.Infection is a known complication of prosthetic arteriovenous (av) grafts; they are frequently associated with cannulation sites, but in this case, the patient was not cannulating with the revised hero graft.Given the limited information available, it is still unclear what the source of the infection was as there are many factors that could have contributed to the reported events: patient co­morbidities, placement of a hemodialysis catheter, prior or ongoing systemic infection and/or wound infection.The original hero graft was implanted 2 years prior to revision and was thus incorporated in the patient's vasculature and arm.The surgeon chose to leave the graft in, rather than explanting it.As described in the hero frequently asked questions, the arterial graft component would typically not be removed due to maturation/incorporation of surrounding tissue into the eptfe material.It can be ligated and left in place similar to conventional av grafts.In this case, the exact surgical details of the revision are unknown.According to the information provided by the patient's aunt, the patient received a second hero graft because of clotting of the first graft implanted 2 years prior.Post-operatively the patient experienced significant swelling of the arm and an unspecified infection.Additionally, the complainant stated that the surgeon claimed that the graft could not be accessed for 6 months.No specifics regarding the patient's medical history (other than bartter's syndrome) or of the reported events are available from the implanting surgeon.Thrombosis of the hero graft is a known potential complication listed in the ifu.Additionally, the nature of the infection is unknown.The hero graft is unlikely to be the direct source of the infection as the production undergoes a validated terminal sterilization process.Because of the limited information available, it is not possible to determine what role, if any, the hero graft played in the reported events.The root cause for the reported event is unknown.

Event Description

According to the report, the patient has bartter's syndrome and had a previous hero graft that was implanted two years ago and not getting adequate dialysis due to clotting.The surgeon implanted a new hero graft on the patient's ipsilateral arm as the previous hero graft access.The patient had a significant drop in blood pressure during surgery and they "just about lost her." the surgeon said that he had a difficult time implanting the hero graft "through all the scar tissue." the patient has been discharged and getting dialysis through the tunneled dialysis catheter.The patient's arm where the hero graft was implanted was swollen twice the size of the normal arm.Instead of the hero graft procedure being an outpatient procedure, the patient was admitted and stayed in the hospital for 3 to 4 days due to the swelling.The patient experienced arm pain.The surgeon discharged the patient with a dialysis catheter in the neck region and said that the hero graft could not be accessed for 6 months.The surgeon was asked the reason for the 6 months waiting time, but he did not provide an answer.This report is for both the hero 1001 and hero 1002 device.

• 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: 4798502
• MDR Text Key: 5829328
• Report Number: 1063481-2015-00069
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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?: No
• Date Manufacturer Received: 05/18/2015
• 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; Other