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

Model Number HERO 1001

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 01/29/2014

Event Type  Injury  

Event Description

According to the report, the cryolife representative was present for the placement of the graft and it was placed under fluoroscopy without incident.The patient was a larger sized woman, which is important to what occurred.After surgery when the patient was in recovery, she was moved to a sitting-up position when she experienced problems with her heart.The surgeon felt that because she was larger, when she sat up it must have moved the end of the graft to a point where it was causing problems.The surgeon surmised that it was not long enough and that his plan was to return her to the or and extend the graft to make it longer.Since only one kit was ordered for this procedure, rather than replace the outflow component to extend it, the surgeon's plan was to extend the inflow graft by sewing graft material to the existing ptfe material.Additional information was received on (b)(4) 2014 that indicated the patient was fine after the length of the graft was extended.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.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.

Manufacturer Narrative

According to the report, the cryolife representative was present for the placement of the graft and it was placed under fluoroscopy without incident.The patient was a larger sized woman, which is important to what occurred.After surgery when the patient was in recovery, she was moved to a sitting-up position when she experienced problems with her heart.The surgeon felt that because she was larger, when she sat up it must have moved the end of the graft to a point where it was causing problems.The surgeon surmised that it was not long enough and that his plan was to return her to the operating room and extend the graft to make it longer.Since only one kit was ordered for this procedure, rather than replace the outflow component to extend it, the surgeon's plan was to extend the inflow graft by sewing graft material to the existing ptfe material.Additional information was received that indicated the patient was fine after the length of the graft was extended.Additional information: the surgeon contacted cryolife and stated that he could not recall the patient having problems with her heart as a result of the hero graft.Instead, he stated that the issue was that he cut the device too short.The patient did not have any issues following the adjustment to the graft.This additional information does not change our initial investigation conclusions.There is no indication that an error or deficiency occurred at cryolife and the event is attributed to surgeon error.

Event Description

According to the report, the cryolife representative was present for the placement of the graft and it was placed under fluoroscopy without incident.The patient was a larger sized woman, which is important to what occurred.After surgery when the patient was in recovery, she was moved to a sitting-up position when she experienced problems with her heart.The surgeon felt that because she was larger, when she sat up it must have moved the end of the graft to a point where it was causing problems.The surgeon surmised that it was not long enough and that his plan was to return her to the operating room and extend the graft to make it longer.Since only one kit was ordered for this procedure, rather than replace the outflow component to extend it, the surgeon's plan was to extend the inflow graft by sewing graft material to the existing ptfe material.Additional information was received that indicated the patient was fine after the length of the graft was extended.

Manufacturer Narrative

Date of this report," was corrected to 01/31/2014.*manufacturer narrative* according to the report, the cryolife representative was present for the placement of the graft and it was placed under fluoroscopy without incident.The patient was a larger sized woman, which is important to what occurred.After surgery when the patient was in recovery, she was moved to a sitting-up position when she experienced problems with her heart.The surgeon felt that because she was larger, when she sat up it must have moved the end of the graft to a point where it was causing problems.The surgeon surmised that it was not long enough and that his plan was to return her to the or and extend the graft to make it longer.Since only one kit was ordered for this procedure, rather than replace the outflow component to extend it, the surgeon's plan was to extend the inflow graft by sewing graft material to the existing ptfe material.Additional information was received that indicated the patient was fine after the length of the graft was extended.Multiple attempts were made to gather additional information and imaging; however, all attempts were unsuccessful.The manufacturing records for the lot were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed on the available information.The available information suggests that the surgeon initially trimmed the venous outflow component too short.The hero graft venous outflow component has freedom of movement.This movement could result in the tip not remaining in the right atrium of the heart which may increase the risk of occlusion.There may be more of a concern if the patient is morbidly obese, which appears to have been the case in this event.The ifu provides precautions and warnings about preplanning and implantation including the use of additional measures if the patient is morbidly obese.The surgeon attributed the patient's heart problems to movement of the tip of the voc when the obese female patient sat up.One possibility for the heart symptoms is that the device moved and the tip was touching the sinoatrial (sa) node of the heart, possibly causing an arrhythmia.The surgeon performed a revision by adding a segment of eptfe material, which pushed the titanium connector more medial and allowed the tip of the voc to sit lower in the right atrium of the heart, which resolved the patient's symptoms.Patient anatomy and physician technique were potential contributing factors.

Event Description

According to the report, the cryolife representative was present for the placement of the graft and it was placed under fluoroscopy without incident.The patient was a larger sized woman, which is important to what occurred.After surgery when the patient was in recovery, she was moved to a sitting-up position when she experienced problems with her heart.The surgeon felt that because she was larger, when she sat up it must have moved the end of the graft to a point where it was causing problems.The surgeon surmised that it was not long enough and that his plan was to return her to the or and extend the graft to make it longer.Since only one kit was ordered for this procedure, rather than replace the outflow component to extend it, the surgeon's plan was to extend the inflow graft by sewing graft material to the existing ptfe material.Additional information was received that indicated the patient was fine after the length of the graft was extended.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 3623289
• MDR Text Key: 4177635
• Report Number: 3006945290-2014-00002
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2014

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: H13VC019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2014; 02/16/2015
• 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