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

Model Number HERO 1001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 07/16/2015

Event Type  Injury  

Event Description

According to the report, the surgeon's last patient experienced an air embolism during implantation of a hero device.The patient was placed in the trendelenburgs position and high o2 was administered to diffuse the emboli.According to the surgeon, "the patient is fine.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the initial report received on 07/17/2015 from the rep, "the surgeon stated it seems that last couple hero kits have been missing the hemostatic plug.His last patient had an air embolism, though his patient is fine.He requested that i come inservice his or staff regarding the kit and its contents.I will do this (b)(6) as the surgeon is out next week." this complaint investigation is in reference to the air embolism experienced by the patient during implant.The rep was in contact with the surgeon via text message on (b)(64 2015.She asked him if there was a connection between the missing hemostatic plug from the hero 1003 accessory kit and the reported embolism.She forward the surgeon's response and is as follows: "would have helped.Component was new resident assistants (it is (b)(6))." the rep clarified via phone on (b)(4) 2015 that the surgeon was conveying in text that he had a new batch of resident interns who he was teaching about implantation of the hero graft.He was going over the contents of the hero kit with the residents, as he was performing a hero implant.It was during this procedure that the patient experienced an embolism which was successfully treated.He was not associating the lack of plug to the embolism as he has never used the plug during implant.It was confirmed on (b)(64 2015 that the date of incident for the embolism is (b)(6) 2015 and that lot numbers for the hero 1001 and hero 1002 devices were unavailable.The rep performed an in-service with the surgeon's staff on (b)(6) 2015 to educate and instruct on the contents and use of the hero 1001, hero 1002, and hero 1003 components.The system was queried for shipping records to houston methodist for the six months prior to the date of implant to determine possible hero 1001 and hero 1002 lot numbers which may have been used during the implant.The query returned seven possible lot numbers which include h14vc052, h14av025, h15vc001, h14av027, h14av029, h15vc009, and h15av004.The manufacturing records for lots h14vc052, h14av025, h15vc001, h14av027, h14av029, h15vc009, and h15av004 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 experienced an air embolism during hero graft implantation.The patient was placed in trendelenburg's and was given high o2 for diffusion, which was successful.The surgeon noted that the hemostatic plug was missing from the "last couple hero kits." however, he later stated that he has never used the plug during implant and per the representative, pinches of the tubing with his fingers.The hero graft instructions for use (ifu) lists embolism as a potential intraoperative and post-operative complication.Additionally, the hero graft frequently asked questions (faq): explant, exchange, revision, or abandonment document recommends placing the patient into trendelenburg position to reduce the potential for air embolus during exchanges; for patients undergoing general anesthesia, a positive breath can be forced during removal of the dilator from the sheath to prevent air induction.It is unclear if the patient was originally placed in the recommended position or if they were placed that way following embolism occurrence.The following information was not reported: operative notes, patient history, and medication history.It is unclear what effect the surgeon's technique of pinching of the tubing with his fingers (instead of using the hemostatic plug) may have had on the occurrence of an air embolism.Without clarification on implant procedure and relevant patient history, the relationship between the hero graft and the air embolism cannot be established.The surgeon stated that he does not use the plug as instructed in the ifu.The risk associated with the omission of this step is currently unknown.However, embolism is known potential complication.

Event Description

According to the report, the surgeon's last patient experienced an air embolism during implantation of a hero device.The patient was placed in the trendelenburgs position and high o2 was administered to diffuse the emboli.According to the surgeon, "the patient is fine.".

• 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: 4960622
• MDR Text Key: 6041147
• Report Number: 1063481-2015-00127
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• 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): Life Threatening