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

Model Number HERO 1001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being re-sent to mark as initial.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report, the surgeons implanted the hero graft on (b)(6) 2015.They began by using short sheath from the hero 1003 accessory kit and had difficulty advancing the venous outflow component (voc) through the sheath and into the internal jugular (ij).One of the surgeons theorized that the sheath may be "kinked" but could not be confirmed.He felt the step off between the stylet and the voc was causing impingement.They removed the short sheath and tried again with the long sheath, but continued to experience difficulties advancing the voc.They proceeded to use an angioplasty balloon instead of the stylet and was able to advance the voc far enough into vein.The sheath was then removed.Advancement of the voc through the ij was difficult due to central venous occlusion (cvo), and confirmation of placement via fluoro was performed.It was discovered that the voc had advanced caudally instead of into heart.The voc was subsequently backed out and they were able to place the outflow into the right atrium (ra).Patient vitals remained stable during procedure.At this point, placement was confirmed via fluoro/contrast, and the radiopaque marker was easily visible and in place.The surgeon then tunneled the voc and graft, connected the two components, and confirmed again device placement via imaging.Imaging confirmed that everything was in place, the voc was in the ra, however the radiopaque marker band was now missing.Further imaging revealed that the marker band was lodged in the "pulmonary system." throughout the procedure, and after discovery of the lodged marker band, patient vitals remained stable.As such, the physicians decided "not to go in and get it." the case was completed and the patient will be kept overnight for observation.Additional information received on (b)(6) 2015 from the surgeon indicated the current status of the patient, "he did great.They used the fistula without issue.No problems.".

Manufacturer Narrative

According to the report , the surgeons implanted the hero graft on (b)(6) 2015.They began by using short sheath from the hero 1003 accessory kit and had difficulty advancing the venous outflow component (voc) through the sheath and into the internal jugular (ij).One of the surgeons theorized that the sheath may be "kinked" but could not be confirmed.He felt the step off between the stylet and the voc was causing impingement.They removed the short sheath and tried again with the long sheath, but continued to experience difficulties advancing the voc.They proceeded to use an angioplasty balloon instead of the stylet and was able to advance the voc far enough into vein.The sheath was then removed.Advancement of the voc through the ij was difficult due to central venous occlusion (cvo), and confirmation of placement via fluoro was performed.It was discovered that the voc had advanced caudally instead of into heart.The voc was subsequently backed out and they were able to place the outflow into the right atrium (ra).Patient vitals remained stable during procedure.At this point, placement was confirmed via fluoro/contrast, and the radiopaque marker was easily visible and in place.The surgeon then tunneled the voc and graft, connected the two components, and confirmed again device placement via imaging.Imaging confirmed that everything was in place, the voc was in the ra, however the radiopaque marker band was now missing.Further imaging revealed that the marker band was lodged in the "pulmonary system." throughout the procedure, and after discovery of the lodged marker band, patient vitals remained stable.As such, the physicians decided "not to go in and get it." the case was completed and the patient will be kept overnight for observation.Additional information received on 10/20/2015 from the surgeon indicated the current status of the patient, "he did great.They used the fistula without issue.No problems." the manufacturing records for lot h14vc041 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The root cause for the reported event is unknown based on the available information.However, the instructions for use thoroughly identifies process and product hazards for approved indications.

Event Description

According to the report , the surgeons implanted the hero graft on (b)(6) 2015.They began by using short sheath from the hero 1003 accessory kit and had difficulty advancing the venous outflow component (voc) through the sheath and into the internal jugular (ij).One of the surgeons theorized that the sheath may be "kinked" but could not be confirmed.He felt the step off between the stylet and the voc was causing impingement.They removed the short sheath and tried again with the long sheath, but continued to experience difficulties advancing the voc.They proceeded to use an angioplasty balloon instead of the stylet and was able to advance the voc far enough into vein.The sheath was then removed.Advancement of the voc through the ij was difficult due to central venous occlusion (cvo), and confirmation of placement via fluoro was performed.It was discovered that the voc had advanced caudally instead of into heart.The voc was subsequently backed out and they were able to place the outflow into the right atrium (ra).Patient vitals remained stable during procedure.At this point, placement was confirmed via fluoro/contrast, and the radiopaque marker was easily visible and in place.The surgeon then tunneled the voc and graft, connected the two components, and confirmed again device placement via imaging.Imaging confirmed that everything was in place, the voc was in the ra, however the radiopaque marker band was now missing.Further imaging revealed that the marker band was lodged in the "pulmonary system." throughout the procedure, and after discovery of the lodged marker band, patient vitals remained stable.As such, the physicians decided "not to go in and get it." the case was completed and the patient will be kept overnight for observation.Additional information received on 10/20/2015 from the surgeon indicated the current status of the patient, "he did great.They used the fistula without issue.No problems.".

• 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: 5361073
• MDR Text Key: 84346907
• Report Number: 1063481-2015-00345
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H14VC041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization