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

Model Number HERO 1001

Device Problem Kinked (1339)

Patient Problem Occlusion (1984)

Event Type  Injury  

Event Description

According to dr.(b)(6), a (b)(6) year old patient who had juvenile diabetes and 15-20 tunneled catheters had a hero graft implanted in march.Dr.(b)(6) said that he has performed a declot on the patient twice both a couple weeks apart.He felt that the hero graft was clotting because it was kinking.The patient has bilateral venous occlusion and he could not use a cephalic vein and used an axillary vein approach.The surgeon stated that "the patient extends his arm over his head like he is swimming as he sleep and pulls the conduit out and when he puts down his arm it kinks causing the clotting." he felt that this was due to the axillary approach.The patient still has the hero graft but is being seen at a different hospital.He did not know the lot number.

Manufacturer Narrative

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

Manufacturer Narrative

According to the field assurance notification form generated by cryolife field assurance from a phone call with dr.(b)(6), a (b)(6) patient who had juvenile diabetes and 15-20 tunneled catheters had a hero graft implanted in (b)(6) of 2015.Dr.(b)(6) said that he had performed a declot on the patient twice, both a couple weeks apart.He felt that the hero graft was clotting because it was kinking.The patient had bilateral venous occlusion and he could not use a cephalic vein and used an axillary vein approach.The surgeon stated that "the patient extends his arm over his head like he is swimming as he sleep and pulls the conduit out and when he puts down his arm it kinks causing clotting." he felt that this was due to the axillary approach and he felt cryolife should give more literature on how to do more approaches.The patient still has the hero graft but is being seen at a different hospital.He did not know the lot number.Sap shipping records were queried from (10/01/2014 to 03/31/2015) for potential lot numbers associated with this complaint.Manufacturing records for lots were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record device kinking or compression is listed in the hero graft instructions for use (ifu) as a potential complication.The ifu identifies implant instructions and cautions to minimize the risk of device kinking.These include use of a shorter introducer, specific note on advancing the venous outflow component (voc), and caution bending the voc beyond 2.5cm diameter.Due to the patient's history of bilateral venous occlusions, the hero implantation deviated from the clinically studied approach.Studies have reported small percentages of patients with axillary implant locations; gage et al.Reported on 7 patients with hero device implantation into the axillary vein.However, as stated on the ifu, use of the hero graft was clinically studied utilizing the internal jugular vein and central venous access through other vein, such as the axillary vein as in this case, has not been studied and therefore the type and frequency of adverse events for this implantation location are currently unknown.Thrombosis is the most common cause of vascular access dysfunction and a potential complication listed in the ifu.De-clotting was the appropriate course of action in both cases of thrombosis.The surgeon noted "the patient extends his arm over his head like he is swimming as he sleep" and he felt that this action caused the conduit to displace causing kinking.Given the anatomic placement of the device in the shoulder area, it is possible that repetitive arm movements and/or implant technique could contribute to the reported kinking.Patient history of multiple tunneled catheters and history of bilateral venous occlusions may have impacted the events in this case.Limited information is available about the events and a definitive root cause could not be determined.Kinking and thrombosis are known potential complications with the hero graft and are listed in the ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to dr.(b)(6), a (b)(6) patient who had juvenile diabetes and 15-20 tunneled catheters had a hero graft implanted in (b)(6).Dr.(b)(6) said that he has performed a declot on the patient twice both a couple weeks apart.He felt that the hero graft was clotting because it was kinking.The patient has bilateral venous occlusion and he could not use a cephalic vein and used an axillary vein approach.The surgeon stated that "the patient extends his arm over his head like he is swimming as he sleep and pulls the conduit out and when he puts down his arm it kinks causing the clotting." he felt that this was due to the axillary approach.The patient still has the hero graft but is being seen at a different hospital.He did not know the lot number.

• 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: 4778499
• MDR Text Key: 5818818
• Report Number: 1063481-2015-00065
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• 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?: Yes
• Date Manufacturer Received: 05/14/2015
• 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): Required Intervention
• Patient Age: 40 YR