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

Model Number HERO 1003

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Type  Death  

Event Description

According to the report from a cryolife representative, on (b)(6) 2015 a surgeon from (b)(6) mentioned a hero case in (b)(6) in which the hero 1003 stylet went through the heart wall during the procedure, which may have resulted in death.Later the same day, a pa-c also mentioned the case in (b)(6).Neither the surgeon nor the pa-c could recall the surgeon's name or hospital name in (b)(6) during the discussions.Date of incident is unknown as well.

Event Description

According to the report from a cryolife representative, on (b)(6) 2015 a surgeon from (b)(6) mentioned a hero case in (b)(6) in which the hero 1003 stylet went through the heart wall during the procedure, which may have resulted in death.Later the same day, a pa-c also mentioned the case in (b)(6).Neither the surgeon nor the pa-c could recall the surgeon's name or hospital name in (b)(6) during the discussions.Date of incident is unknown as well.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, "on (b)(6) 2015 a surgeon mentioned a hero case in (b)(6) in which the stylet went through the heart wall during the procedure.He also said that cryolife may not be aware of the case in (b)(6) yet.Later the same day, a physicians assistant (pa) also mentioned the case in (b)(6).Neither the surgeon nor the pa could recall the surgeon's name or hospital name during the discussions.Date of incident is unknown as well." additional clarifying information regarding the event was requested from the surgeon who reported the case initially, but he was unable to provide further details regarding the alleged event other than it had occurred in (b)(6).The two cryolife representatives for the (b)(6) region, were contacted via phone on 02/25/2015 to inquire if they were aware of any reports regarding the alleged event.Neither representative had heard of anything that would allude to such an event.A clinical review was performed based on the available information.No information regarding the implanter, procedure, institution, or patient history and comorbidities are available.The instructions for use (ifu) gives specific and detailed guidance as to the implantation of the hero graft, including details regarding the use of the stylet and includes the following statement: "caution: do not advance the tip of the delivery stylet into the right atrium." death is a known risk of any surgical procedure.Additionally, the ifu list patient death as a potential post-operative complication with rates of 0%-1.9% for patient's receiving a hero graft.With the information available it is not possible to determine the relationship, if any, between the cause of death and the hero graft.However, the stylet does have a slightly pointed end so it is plausible that it could puncture the heart wall, which would cause bleeding and potential death.A medical review was performed based on the available information.According to the report, the stylet perforated the heart wall during implantation of a hero device.No other details regarding the event are known.The stylet is a rigid device with a sharp tip which could potentially perforate the heart wall if advanced too far.Adequate warning against advancing the stylet into the right atrium are provided in the ifu.

• Brand Name: HERO GRAFT COMPONENT KIT
• 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: 4544006
• MDR Text Key: 5513925
• Report Number: 1063481-2015-00025
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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 1003
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2015
• 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): Death