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

Model Number HERO 1002

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/29/2014

Event Type  Injury  

Event Description

According to the report, three months after the implant, the patient visited the hospital with an infection approximately 1cm in length, close to the arterial anastomosis.This resulted in "surgical revision of the infected part.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, three months after the implant ((b)(6) 2014), the patient visited the hospital on (b)(6) 2014 with an infection approximately one cm in length, close to the arterial anastomosis.The surgeon performed a surgical revision of the infected section.Additional information was received from the distributor on (b)(6) 2015 stating, "we had discussed the issue with the surgeon and he said that he has no plan for more investigation.He gave the antibiotic to the patient and he will not remove the hero graft." the hero graft ifu lists infection as a potential complication.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.Infection is a known complication of prosthetic arteriovenous (av) grafts.They are frequently associated with cannulation sites but is most likely not in this situation given the close proximity to the arterial anastomosis.A focal graft infection can be clinically managed via surgical revision and antibiotic therapy as was done with this patient.Given the limited information available it is still unclear what the source of the infection was as there are many factors that could have contributed to the reported event: patient co-morbidities, placement of a hemodialysis catheter, prior or ongoing systemic infection and/or wound infection.Without information about the source of the infection, type of infection, patient comorbidities, and/or pre-existing infections; the relationship of the infection to the hero graft device and the patient cannot be determined.Infection is a known potential complication listed in the hero graft instructions for use (ifu).The hero graft ifu contraindicates use of the hero device in patients with known preexisting bacteremia.In addition, instructions for screening blood cultures to rule out asymptomatic bacteremia and recommended antibiotic therapy are also provided in the ifu.There is no indication that an error or deficiency occurred at cryolife.

Event Description

According to the report, three months after the implant, the patient visited the hospital with an infection approximately 1cm in length, close to the arterial anastomosis.This resulted in "surgical revision of the infected part.".

Manufacturer Narrative

According to the report, three months after the implant ((b)(6) 2014), the patient visited the hospital on (b)(6) 2014 with an infection approximately one cm in length, close to the arterial anastomosis.The surgeon performed a surgical revision of the infected section.Additional information was received from the distributor on 01/05/2015 stating, "we had discussed the issue with the surgeon and he said that he has no plan for more investigation.He gave the antibiotic to the patient and he will not remove the hero graft." lot numbers were provided from the distributor.Lot h14av002 is currently being investigated.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report, three months after the implant, the patient visited the hospital with an infection approximately 1cm in length, close to the arterial anastomosis.This resulted in "surgical revision of the infected part.".

Manufacturer Narrative

(b)(4) was originally closed on 2/27/2015.The complaint was re-opened on 3/4/2015 to investigate the lot numbers which were provided by the distributor.According to the report received from (b)(6), cryolife representative, three months after the implant ((b)(6) 2014), the patient visited the hospital on (b)(6) 2014 with an infection approximately one cm in length, close to the arterial anastomosis.The surgeon performed a surgical revision of the infected section.The distributor passed along the following information from a subsequent discussion between the distributor and the surgeon, "we had discussion last week with the doctor and he understood the infection is not related to the product." additional information was received from the distributor on 01/05/2015 stating, "we had discussed the issue with the surgeon and he said that he has no plan for more investigation.He gave the antibiotic to the patient and he will not remove the hero graft." the manufacturing records for lot h14av002 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Product is terminally sterilized by a validated method and pcd's were found to be sterile post-processing.Without information about the source of the infection, type of infection, patient comorbidities, and/or pre-existing infections; the relationship of the infection to the hero graft device and the patient cannot be determined.Infection is a known potential complication listed in the hero graft instructions for use (ifu).The hero graft ifu contraindicates use of the hero device in patients with known preexisting bacteremia.In addition, instructions for screening blood cultures to rule out asymptomatic bacteremia and recommended antibiotic therapy are also provided in the ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the report, three months after the implant, the patient visited the hospital with an infection approximately 1cm in length, close to the arterial anastomosis.This resulted in "surgical revision of the infected part.".

• 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: 4372202
• MDR Text Key: 5232629
• Report Number: 3006945290-2014-00112
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HERO 1002
• Device Lot Number: H14AV002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• 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): Required Intervention