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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problems Thrombosis (2100); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the report, "at a meeting in (b)(6) on (b)(6) 2015 (b)(6) informed (b)(6) of cryolife that he had recently visited (b)(6) where he had occasion to discuss the hero graft.He reports that he learned that all (b)(6) recipients of the hero graft had this method of dialysis abandoned due to thrombosis of the hero.He stated that he did not think the (b)(6) healthcare system was set up to monitor hero patients, nor that they had the facilities to perform thrombectomies.Nb: it is almost certain that all (b)(6) hero graft recipients were implanted in other countries; some, possibly in (b)(6)." as it is unclear what hero graft component was involved, the investigation will incorporate both hero 1001 and 1002 components.This investigation will be reported under hero 1001.

Manufacturer Narrative

According to the report, "at a meeting in (b)(6) on (b)(6) 2015 mr.(b)(6) informed (b)(4) of cryolife that he had recently visited (b)(6) where he had occasion to discuss the hero graft.He reports that he learned that all (b)(6) recipients of the hero graft had this method of dialysis abandoned due to thrombosis of the hero.He stated that he did not think the (b)(6) healthcare system was set up to monitor hero patients, nor that they had the facilities to perform thrombectomies.Nb: it is almost certain that all (b)(6) hero graft recipients were implanted in other countries; some, possibly in (b)(6)." as it is unclear what hero graft component was involved, the investigation will incorporate bothe hero 1001 and 1002 components.This investigation will be reported under hero 1001.Multiple attempts have been made to obtain additional information without success.No additional information is expected regarding the reported events.The manufacturing records were not reviewed as definitive lot numbers are unavailable and dates of implant are unknown.As dates of implant for the hero devices are unknown, the system could not be queried for potential lots shipped to the hospital.There was a report in (b)(6) of 2015 that "all (b)(6) recipients of the hero graft had this method of dialysis abandoned due to thrombosis of the hero." the initial complaint notification states "it is almost certain that all (b)(6) hero graft recipients were implanted in other countries" and the surgeon reported "he did not think the (b)(6) healthcare system was set up to monitor hero patients, nor that they had the facilities to perform thrombectomies." an update confirmed the only known information regarding these cases is that the "patients who had the hero grafts had blocked hero grafts that needed thrombolectomy and the (b)(6) hospital did not know how to do this".Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu), as is prosthesis failure.Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Thrombosis is the most common cause of vascular access dysfunction.Missed hemodialysis sessions significantly increase the number of thrombosis episodes in arteriovenous fistulas (avfs) and arteriovenous grafts (avgs).Additional information on patient medical history, implant and intervention notes, and dialysis information was not provided.Without additional information the relationship between the thrombosis events and the hero graft cannot be determined.Hero graft patency maintenance requires a healthcare infrastructure which can perform the appropriate interventions and provide follow-up as needed; from the surgeon's statements it doesn't appear that the patients in this complaint had access to the necessary healthcare and as such their grafts were not maintained and the hero graft was abandoned.

Event Description

According to the report, "at a meeting in (b)(6) on (b)(6) 2015 mr.(b)(6) informed (b)(4) of cryolife that he had recently veisited (b)(6) where he had occasion to discuss the hero graft.He reports that he learned that all (b)(6) recipients of the hero graft had this method of dialysis abandoned due to thrombosis of the hero.He stated that he did not think the (b)(6) healthcare system was set up to monitor hero patients, nor that they had the facilities to perform thrombectomies.Nb: it is almost certain that all (b)(6) hero graft recipients were implanted in other countries; some, possibly in (b)(6)." as it is unclear what hero graft component was involved, the investigation will incorporate both hero 1001 and 1002 components.This investigation will be reported under hero 1001.

• 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: 5360098
• MDR Text Key: 35657169
• Report Number: 1063481-2016-00005
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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 1001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• 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