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

Model Number HERO 1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Sudden Cardiac Death (2510)

Event Date 11/24/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the initial report, the interventional radiologist and surgeon teamed up to implant hero graft.The radiologist did a cut down on the left side ij and gained access to the ivc.He exchanges to stiff.035 wire, and then inserts the venous outflow component without any problems.He clamps it off to hand off to the surgeon who identifies and dissects his arterial anastomoses site.He then tunnels the voc to the dpg.He then tunnels the graft from the dpg to the target arterial anastomoses site.He cuts the voc and connects it to the graft.Next he sutures the arterial anastomoses all without any troubles or reasons to believe there was any problem.They then noticed that the patients bp was pretty low and seemed to be getting lower.The anesthesiologist started administering drugs to try and bring up bp for probably 3-5 min.The surgeon mentioned that he thought it might have been a mi.He said the patient had a bypass a few years prior.Additional information from the rep on (b)(6) 2015 indicated "i spoke with the account yesterday, and found out the patient did expire and the account did attribute the death to an mi and had nothing to do with the hero graft." the scope of the investigation will include hero 1001 and 1002 components but will be reported under hero 1001.

Manufacturer Narrative

Corrected data: the scope of the investigation included hero 1001, 1002, and 1003 components.According to the initial report, the interventional radiologist and surgeon teamed up to implant hero graft.The radiologist did a cut down on the left side ij and gained access to the ivc.He exchanges to stiff.035 wire, and then inserts the venous outflow component without any problems.He clamps it off to hand off to the surgeon who identifies and dissects his arterial anastomoses site.He then tunnels the voc to the dpg.He then tunnels the graft from the dpg to the target arterial anastomoses site.He cuts the voc and connects it to the graft.Next he sutures the arterial anastomoses all without any troubles or reasons to believe there was any problem.They then noticed that the patients bp was pretty low and seemed to be getting lower.The anesthesiologist started administering drugs to try and bring up bp for probably 3-5 min.The surgeon mentioned that he thought it might have been a mi.He said the patient had a bypass a few years prior.Additional information from the rep on 12/03/2015 indicated "i spoke with the account yesterday, and found out the patient did expire and the account did attribute the death to an mi and had nothing to do with the hero graft."." he provided the associated lot numbers (h14vc049, h14av024, h14ak012) on 12/16/2015.The manufacturing records for lots h14vc049, h14av024, and h14ak012 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's hero graft surgery was initiated on (b)(6) 2015.During implant the surgeon noted that the patient's blood pressure was "pretty low" and continued to drop.The anesthesiologist administered drugs for approximately three to five minutes to try and bring the blood pressure back up.However, the patient coded and was unable to be resuscitated.The rep that present during the case spoke with the surgeon, who initially believed "it might have been an mi" and had a "bypass a few years prior." it was later confirmed that "the account did attribute the death to an mi and had nothing to do with the hero graft." the following information was not provided: patient medical history (aside from the history of bypass) and implant notes.The relationship between the hero graft and the patient mi and resulting death, cannot be determined without additional information.The hero graft instructions for use (ifu) lists mi and death as potential intraoperative and post-operative complications.However, information from the case stated that the hero graft was related to the reported events.The cause of death was mi; the cause of the mi is unknown.However, the patient had a known history of ischemic heart disease.The hero was not involved in the reported events according to the account.

Event Description

According to the initial report, the interventional radiologist and surgeon teamed up to implant hero graft.The radiologist did a cut down on the left side ij and gained access to the ivc.He exchanges to stiff.035 wire, and then inserts the venous outflow component without any problems.He clamps it off to hand off to the surgeon who identifies and dissects his arterial anastomoses site.He then tunnels the voc to the dpg.He then tunnels the graft from the dpg to the target arterial anastomoses site.He cuts the voc and connects it to the graft.Next he sutures the arterial anastomoses all without any troubles or reasons to believe there was any problem.They then noticed that the patients bp was pretty low and seemed to be getting lower.The anesthesiologist started administering drugs to try and bring up bp for probably 3-5 min.The surgeon mentioned that he thought it might have been a mi.He said the patient had a bypass a few years prior.Additional information from the rep on 12/03/2015 indicated "i spoke with the account yesterday, and found out the patient did expire and the account did attribute the death to an mi and had nothing to do with the hero graft." the scope of the investigation will include hero 1001, 1002, and 1003 components but will be reported 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: 5306927
• MDR Text Key: 33785867
• Report Number: 1063481-2015-00357
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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: SEE H10
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• 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