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

Model Number HERO 1001

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 02/12/2015

Event Type  Injury  

Event Description

According to the report, a patient has developed superior vena cava syndrome after receiving a hero graft.

Manufacturer Narrative

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

Manufacturer Narrative

Originally it was reported to cryolife that a patient has developed superior vena cava syndrome (svcs) after receiving a hero graft.Additional information was received from the distributor on 03/05/2015.The surgeon is doctor (b)(6).The date of implant as (b)(6) 2014 and the date svcs was discovered (b)(6) 2015.As per the agent in tenerife, the patient is stable is under controlled by the dialysis center, not in the hospital, and he doesn't have any important problem.Further additional information was received from the surgeon on 03/19/2015 in the form of a letter that the surgeon emailed to cryolife.The letter stated: "i'm not certain about your source of information but i am aware that the nephrology department of my institution made a comment to the sales person that is distributing your graft, regarding this case.But as i am the person responsible for this patient's implant, i thank you for contacting me.I have to say that the information you received is incorrect.The patient that received the hero implant has an esrd with multiple failed vascular accesses with both native vessels and prosthetic grafts in both arms.Besides this, the patient had a heart transplant and a chronic inferior vena cava thrombosis as well as thrombosis of both jugular vein systems and right arm subclavian vein.The only venous patent vessel is the left sc vein through which we implanted the hero graft as lifesaving opportunities as no other vascular access were possible.The patient had a mild superior vena cava syndrome prior to the hero graft implant and both, the patient, and relatives were informed orally and in the informed consent, signed by the patient's daughter, because the patient is unable to sign due to a previous stroke sequel, that a scvs decompensation may occur due to the hero implant.Two months after the hero graft implant, the patient was sent from the hemodialysis department to the emergencies department to be assessed because of a mild decompensation of his svcs that was resolved without further treatment.The patient had developed left arm and facial oedema repeatedly after the hero implant but the same have always resolved without specific treatment.The nephrologist in charge of the patient's hemodialysis told me that the hero graft was having an outstanding performance and in the patient's last visit to our outpatient clinic, he showed very happy with the hero graft but above all, to be alive.For all this, i consider that no actions need to be taken by cryolife and there are no regulatory obligations you may fulfil." the manufacturing records for lot h14vc044 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Given the clarification and definitive affirmation by the surgeon that there is no alleged deficiency of the hero graft, and that svcs was present prior to the hero graft implant, no complaint investigation is warranted.Given these findings, implantation of hero graft was not the cause the reported event; therefore, the complaint will be voided.

Event Description

Originally it was reported to cryolife that a patient has developed superior vena cava syndrome (svcs) after receiving a hero graft.Additional information was received from the distributor on 03/05/2015.The surgeon is doctor (b)(6).The date of implant as (b)(6) 2014 and the date svcs was discovered (b)(6) 2015.As per the agent in tenerife, the patient is stable is under controlled by the dialysis center, not in the hospital, and he doesn't have any important problem.Further additional information was received from the surgeon on 03/19/2015 in the form of a letter that the surgeon emailed to cryolife.The letter stated: "i'm not certain about your source of information but i am aware that the nephrology department of my institution made a comment to the sales person that is distributing your graft, regarding this case.But as i am the person responsible for this patient's implant, i thank you for contacting me.I have to say that the information you received is incorrect.The patient that received the hero implant has an esrd with multiple failed vascular accesses with both native vessels and prosthetic grafts in both arms.Besides this, the patient had a heart transplant and a chronic inferior vena cava thrombosis as well as thrombosis of both jugular vein systems and right arm subclavian vein.The only venous patent vessel is the left sc vein through which we implanted the hero graft as lifesaving opportunities as no other vascular access were possible.The patient had a mild superior vena cava syndrome prior to the hero graft implant and both, the patient, and relatives were informed orally and in the informed consent, signed by the patient's daughter, because the patient is unable to sign due to a previous stroke sequel, that a scvs decompensation may occur due to the hero implant.Two months after the hero graft implant, the patient was sent from the hemodialysis department to the emergencies department to be assessed because of a mild decompensation of his svcs that was resolved without further treatment.The patient had developed left arm and facial oedema repeatedly after the hero implant but the same have always resolved without specific treatment.The nephrologist in charge of the patient's hemodialysis told me that the hero graft was having an outstanding performance and in the patient's last visit to our outpatient clinic, he showed very happy with the hero graft but above all, to be alive.For all this, i consider that no actions need to be taken by cryolife and there are no regulatory obligations you may fulfil.".

• 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: 4540944
• MDR Text Key: 5543925
• Report Number: 1063481-2015-00024
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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?: No
• Date Manufacturer Received: 02/20/2015
• 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