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

Model Number HERO 1002

Device Problems Device Damaged by Another Device (2915); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Ulcer (2274)

Event Type  Injury  

Event Description

According to the notification form, "(b)(6).Left upper limb using accuseal.Perigraft haematoma at 1 month related to early needling which then got infected and created ulcer 5 cm proximal to anastomosis therefore device removed.Was working very well.Line removed at implant.".

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, "(b)(6) female.Left upper limb using accuseal.Perigraft haematoma at 1 month related to early needling which then got infected and created ulcer 5 cm proximal to anastomosis therefore device removed.Was working very well.Line removed at implant." multiple attempts were made to gather more information.The surgeon stated that he did not have the time to go through patient notes for further information and that he would not be supplying any further information.He stated he did not feel the issues he relayed in his email were hero related and that he was not reporting them.The surgeon also stated "i have no concerns regarding hero as a causative factor in any of these cases.I have not issued any form of complaint regarding these cases.Going through these cases retrospectively will not be necessary in my opinion." a review of manufacturing records could not be performed as lot numbers are unknown.Furthermore, shipping records could not be queried for possible lot numbers as the date of implant is unknown.A review was performed of the available information.This is a case of a patient implanted with a hero graft anastomosed to an acuseal graft.This patient developed a peri-graft hematoma 1 month post-implant.The hero instructions for use (ifu) lists hematoma as a potential intraoperative and post-operative complication.The surgeon's note stated that the hematoma was related to "early needling" and resulted in an infection which led to ulcer formation.The ifu also lists infection and abnormal healing as potential complications.Infection is a known complication of prosthetic arteriovenous (av) grafts.The patient selection considerations listed in the hero graft 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.Patient history of blood modifiers, blood pressure medication and bacteremia is not available.The surgeon chose to explant the device.The source of this local infection was the hematoma.At this time, the role of the hero graft in the hematoma and resulting infection/ulcer events cannot be determined with the limited information.The operative notes for the hero implant or explant were not provided.The patient reported here had a procedure modification to include an acuseal graft attached to the arterial graft component.The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft, in conjunction with an acuseal graft have not been evaluated by cryolife.However, the acuseal graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.The root cause/conclusion is that the hematoma and other reported events described were related to cannulation of the acuseal graft and are not hero graft related.

Event Description

According to the notification form, "(b)(6) female.Left upper limb using accuseal.Perigraft haematoma at 1 month related to early needling which then got infected and created ulcer 5 cm proximal to anastomosis therefore device removed.Was working very well.Line removed at implant.".

• 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: 4922208
• MDR Text Key: 6011655
• Report Number: 1063481-2015-00119
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2015
• 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
• Patient Age: 39 YR