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

Model Number HERO 1001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the report, the surgeon placed a hero graft on (b)(6) 2015.The procedure went smoothly and he took a final fluoroscopy picture at the end of the procedure showing the venous outflow component placed in the mid to upper right atrium.Bruit and thrill were good.The dialysis clinic called yesterday to report that the graft had thrombosed." the surgeon "began to perform a thrombectomy today.Upon taking a picture under fluoro, he found that the venous outflow component had become dislodged from the atrium and the vein.He reported that it was kinked up near her neck.The connector and graft were both still in the appropriate positions.The venous outflow component was removed today and the arterial graft ligated." the surgeon "reports no problem with the components, only wishes to understand if there have been other reported instances and how he might prevent it happening again in the future." a fluoro image was taken in the operating room on the day of implant showing that the tip of the venous outflow component (voc) was in the mid-upper atrium.However, the surgeon discovered over the weekend that a post operative x-ray was taken that showed the voc already beginning to slip when the patient was in recovery.Voc was not tacked down.However, the surgeon pointed out that you can see in the images that the position of the connector was not affected, it is in the same place, only the voc was displaced.The dialysis clinic thought the graft was thrombosed because there was no bruit and the patient was hypertensive.The surgeon spoke with the patient and determined that the cause of the voc migration was not due to patient activity or non-compliance post procedure.The patient was a large breasted woman which may have played a role in the voc migration when the patient was supine.

Manufacturer Narrative

According to the report, the surgeon placed a hero graft on (b)(6) 2015.The procedure went smoothly and he took a final fluoroscopy picture at the end of the procedure showing the venous outflow component placed in the mid to upper right atrium.Bruit and thrill were good.The dialysis clinic called yesterday to report that the graft had thrombosed." the surgeon "began to perform a thrombectomy today.Upon taking a picture under fluoro, he found that the venous outflow component had become dislodged from the atrium and the vein.He reported that it was kinked up near her neck.The connector and graft were both still in the appropriate positions.The venous outflow component was removed today and the arterial graft ligated." the surgeon "reports no problem with the components, only wishes to understand if there have been other reported instances and how he might prevent it happening again in the future." a fluoro image was taken in the operating room on the day of implant showing that the tip of the venous outflow component (voc) was in the mid-upper atrium.However, the surgeon discovered over the weekend that a post operative x-ray was taken that showed the voc already beginning to slip when the patient was in recovery.Voc was not tacked down.However, the surgeon pointed out that you can see in the images that the position of the connector was not affected, it is in the same place, only the voc was displaced.The dialysis clinic thought the graft was thrombosed because there was no bruit and the patient was hypertensive.The surgeon spoke with the patient and determined that the cause of the voc migration was not due to patient activity or non-compliance post procedure.The patient was a large breasted woman which may have played a role in the voc migration when the patient was supine.The manufacturing records for lot h15vc016 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 was implanted with a hero graft on (b)(6) 2015.On (b)(6) 2015 a dialysis clinic diagnosed the patient with thrombosis secondary to no bruit in the graft and the patient's hypertensive state.The surgeon started to perform a thrombectomy on (b)(6) 2015, however during the procedure the surgeon observed the venous outflow component (voc) had dislodged from the right atrium [the fluoroscopy photo was provided] and the issue was migration and not actual thrombosis.The surgeon also noted that the voc was kinked up near the patient's neck.The arterial graft component (agc) and the connector did not migrate.The surgeon had confirmed placement of the voc tip in the mid-upper atrium under fluoroscopy during the implant procedure, however a post-op x-ray showed "the voc already beginning to slip when the patient was in recovery" [the x-ray photo was provided].The surgeon removed the voc and ligated the agc.It was noted that the voc was not tacked down and that the surgeon "determined that the cause of the voc migration was not due to patient activity or non-compliance post procedure".Device migration is listed on the hero graft instructions for use (ifu) as a potential vascular graft and catheter complication.Directions on how to place the graft are provided in the ifu.The surgeon noted that "the patient was a large breasted woman, which may have played a role in the voc migration when the patient was supine".The fluoroscopic image shows that the marker band appears to have migrated superiorly out of the right atrium.The mid portion of the voc appears to be inferiorly displaced as compared to the previous plain film x-ray.This change suggests that movement of the subcutaneous tissue may have contributed to displacement of the voc.At this time, the precise role of the hero graft in this case of device migration cannot be determined without operative notes and a more detailed patient history.As the surgeon stated, the patient's physical build may have been a contributing factor in the device migration, which lead to the observed kinking.

Event Description

According to the report, the surgeon placed a hero graft on (b)(6) 2015.The procedure went smoothly and he took a final fluoroscopy picture at the end of the procedure showing the venous outflow component placed in the mid to upper right atrium.Bruit and thrill were good.The dialysis clinic called yesterday to report that the graft had thrombosed." the surgeon "began to perform a thrombectomy today.Upon taking a picture under fluoro, he found that the venous outflow component had become dislodged from the atrium and the vein.He reported that it was kinked up near her neck.The connector and graft were both still in the appropriate positions.The venous outflow component was removed today and the arterial graft ligated." the surgeon "reports no problem with the components, only wishes to understand if there have been other reported instances and how he might prevent it happening again in the future." a fluoro image was taken in the operating room on the day of implant showing that the tip of the venous outflow component (voc) was in the mid-upper atrium.However, the surgeon discovered over the weekend that a post operative x-ray was taken that showed the voc already beginning to slip when the patient was in recovery.Voc was not tacked down.However, the surgeon pointed out that you can see in the images that the position of the connector was not affected, it is in the same place, only the voc was displaced.The dialysis clinic thought the graft was thrombosed because there was no bruit and the patient was hypertensive.The surgeon spoke with the patient and determined that the cause of the voc migration was not due to patient activity or non-compliance post procedure.The patient was a large breasted woman which may have played a role in the voc migration when the patient was supine.

• 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: 5117565
• MDR Text Key: 27244047
• Report Number: 1063481-2015-00235
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/04/2015

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: H15VC016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• 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): Other; Required Intervention