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

Model Number HERO 1002

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

Patient Problems Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/15/2015

Event Type  Injury  

Event Description

According to the report, "the surgeon revised a previously implanted hero graft in a patient at (b)(6) today.The arterial graft component (agc) has an issue with weeping near the arterial inflow of the graft.He had interventional radiology (ir) deploy a viabahn 8x10cm covered stent near the arterial inflow.After deployment of the stent, he made an incision near the arterial inflow and excised 'flubber' which is a gelatinous mass that forms with weeping.The surgeon said that this gelatinous mass is normal when weeping occurs.He was planning on using bioglue at the area around the arterial anastomosis to seal this area that was not covered by the viabahm." additionally, the report stated "the reason why the hero graft arterial graft component (hero 1002) was being treated was to decompress the fluid in the arm and to relieve the patient of discomfort.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report "the surgeon revised a previously implanted hero graft in a patient at (b)(6) today.The arterial graft component (agc) has an issue with weeping near the arterial inflow of the graft.He had interventional radiology (ir) deploy a viabahn 8x10 cm covered stent near the arterial inflow.After deployment of the stent, he made an incision near the arterial inflow and excised 'flubber' which is a gelatinous mass that forms with weeping.The surgeon said that this gelatinous mass is normal when weeping occurs.He was planning on using bioglue at the area around the arterial anastomosis to seal this area that was not covered by the viabahn." additionally, the report stated "the reason why the hero graft arterial graft compononent (hero 1002) was being treated was to decompress the fluid in the arm and to relieve the patient of discomfort." attempts to contact the surgeon and/or his assistant to obtain additional information were made on 05/18/2015, 05/26/2015 and 06/02/2015 without success.A manufacturing record review could not be performed as lot numbers were unavailable.Furthermore, the date of implant is also unknown and therefore records could not be queried for potential hero lot numbers shipped to the hospital.A seroma is a collection of sterile, clear, ultrafiltered serum surrounded by a nonsecretory fibrous pseudocapsule.Seromas have been reported with both dacron and polytetrafluoroethylene (ptfe) grafts, most commonly when they are placed in subcutaneous locations and are sometimes referred to as a weeping graft.Seromas are listed in the hero instructions for use (ifu) as potential vascular graft and catheter complications.Early seromas are not uncommon with prosthetic a-v grafts and frequently resolve without intervention.The associated edema in this case, however, required intervention.Edema is also listed in the ifu as a potential complication.Revision of the graft, including removal of the "gelatinous mass," was an appropriate course of action.As stated in the video from the surgeon, the seroma was not an indication of infection, but was consistent with weeping syndrome.The comorbidities and other medical history, as well as current medication, are unknown for this patient; therefore no conclusion can be made as to their impact on the reported events.Furthermore, operative notes were not available.A patient experienced weeping of the agc at some unknown point after hero graft implant.The exudate created a gelatinous mass that required surgical excision to relieve patient discomfort.Weeping is a known complication of ptfe grafts that results from an exudate of plasma proteins from the graft into surrounding tissue.The viabahn stent has a covering material that will serve to seal the luminal wall of the agc and prevent further weeping.The root cause for the reported events is weeping of the agc which is a known potential complication of ptfe grafts.

Event Description

According to the report, "the surgeon revised a previously implanted hero graft in a patient at (b)(6) today.The arterial graft component (agc) has an issue with weeping near the arterial inflow of the graft.He had interventional radiology (ir) deploy a viabahn 8x10cm covered stent near the arterial inflow.After depoloyment of the stent, he made an incision near the arterial inflow and excised 'flubber' which is a gelatinous mass that forms with weeping.The surgeon said that this gelatinous mass is normal when weeping occurs.He was planning on using bioglue at the area around the arterial anastomosis to seal this area that was not covered by the viabahm." additionally, the report stated "the reason why the hero graft arterial graft compononent (hero 1002) was being treated was to decompress the fluid in the arm and to relieve the patient of discomfort.".

• 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: 4784378
• MDR Text Key: 5881686
• Report Number: 1063481-2015-00068
• 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: 05/15/2015

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 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• 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): Hospitalization