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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 12/15/2015

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, hero patient (b)(6) was implanted with a hero on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 for a pelvic fracture.The patient had an open thrombectomy for a fully occluded hero on (b)(6) 2015.The scope of the investigation will include both hero 1001 and 1002 components but will be reported under 1001.

Manufacturer Narrative

According to the report, (b)(6) was implanted with a hero on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 for a pelvic fracture.The patient had an open thrombectomy for a fully occluded hero on (b)(6) 2015.The scope of the investigation will include both hero 1001 and 1002 components but will be reported under 1001.Additional medical records were provided on (b)(6) 2015 as well as case report forms (crfs) on (b)(6) 2016.The right side hero graft (hero 1001 and 1002, lots h15vc019 and h15av012) was implanted on (b)(6) 2015 with a brachial anastomosis via gore accuseal modification.The patient was hospitalized on (b)(6) 2015 for a pelvic fracture and was discharged on (b)(6) 2015.An open thrombectomy was successfully performed on (b)(6) 2015 for a fully occluded hero.The patient has a history of patient with history of end-stage renal disease (esrd), diabetes, osteoarthritis, obesity, hyperlipidemia, hypertension, peripheral neuropathy, hypothyroid, chronic obstructive pulmonary disorder (copd), coronary atherosclerosis, hyperparathryoidism, osteoporosis, coronary artery disease (cad), and vitamin d deficiency.The manufacturing records for lots h15vc019 and h15av012 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.This hero registry patient was implanted with a hero graft on (b)(6) 2015.The hero graft was anastomosed to a gore accuseal graft and it was implanted with a brachiai anastomosis with the internal jugular vein as the venous access point.The first date of cannulation was (b)(6) 2015.The patient's medical history includes diabetes mellitus, obesity, hypertension, hypothyroid, chronic obstructive pulmonary disease, coronary atherosclerosis, coronary artery disease, osteoarthritis, and osteoporosis.On (b)(6) 2015 the patient presented to the emergency room with left hip pain post fall.A workup revealed impaction fraction of the left inferior pubic ramus.The patient had a history of multiple conditions affecting the bones and was reported to fall at home; this event had no relationship with the hero graft.On (b)(6) 2015 the patient had an open thrombectomy for a fully occluded hero graft, which ultimately restored flow.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The implant form documented that the patient was prescribed aspirin post operatively; the 1 month follow-up form documents that the patient was also taking heparin.Prescription compliance and past medication history is unknown.The specific relationship between the thrombosis/occlusion event and the hero graft cannot be determined based on the available information.The patient had a procedure modification to include an accuseal graft attached to the arterial graft component (agc).The hero graft ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with an accuseal graft have not been evaluated by cryolife.The acuseal graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.

Event Description

According to the report, (b)(6) was implanted with a hero on (b)(6) 2015.The patient was hospitalized on (b)(6) 2015 for a pelvic fracture.The patient had an open thrombectomy for a fully occluded hero on (b)(6) 2015.The scope of the investigation will include both hero 1001 and 1002 components but will be reported under 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: 5370197
• MDR Text Key: 36086747
• Report Number: 1063481-2016-00006
• 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,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• 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: H15VC019, H15AV012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• 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
• Patient Age: 68 YR