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

Model Number HERO 1002

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 12/22/2014

Event Type  Injury  

Event Description

According to the report, documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was "miller procedure & a".The outcome was listed as flow restored.

Manufacturer Narrative

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

Manufacturer Narrative

According to the notification form received, "documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was 'miller procedure & a [angiogram].' the outcome was listed as flow restored." operative notes were provided by the surgeon who describes the miller procedure and angiogram which were performed.The operative notes also state, "the patient tolerated the procedure well and had a palpable pulse after conclusion of the procedure and her ischemic rest pain resolved immediately." manufacturing records for lot 0001946 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero, and 3.8% in avg.Steal syndrome is not unique to hero graft and is a well-known complication of arteriovenous (av) access conduits; fistula, prosthetic, biologic and xenograft inclusive.Banding procedures are well established treatments to relieve steal syndrome and reestablish vascular access, as was donor in this situation.The patient experienced steal syndrome 2 weeks after implant of the hero device.Steal syndrome is a known potential complication of the hero device due to shunting of arterial blood into the venous system.The steal syndrome was adequately treated with banding "miller procedure." the root cause for the reported event is excessive shunting of arterial blood into the venous circulation.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.This known potential complication is common among all arteriovenous grafts, and does not suggest that there is a deficiency in the hero graft or the hero graft ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Manufacturer Narrative

According to the initial report on 05/27/2015, "documentation of hero graft intervention on 1 month follow-up," the "hero graft [hero 1002, lot 0001946] implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was miller procedure & a [angiogram].' the outcome was listed as flow restored." additional information was received on 08/31/2015, "documentation of two hero graft [hero 1002, lot 0001946] interventions on 6 month follow-up" which was a previous complaint submitted with this patient and reported as 2536."hero graft implanted on (b)(6) 2014].Reason for interventions was documented as unknown and the type of intervention was listed as unknown.However, the outcomes were documented as [?]flow restored.' information has been requested from the coordinator." operative notes regarding the interventions performed were received from the clinical site on 09/01/2015.On (b)(6) 2015 the following procedure was performed: "fistulogram including backflush into the arterial segment, pta [percutaneous transluminal angioplasty] venous of the portion of the graft just before the titanium connector with an 8 balloon" and a postoperative diagnosis of "malfunctioning left arm hero.She has a stenosis just before the titanium connector of the fistula of 60%." on (b)(6) 2015 the following procedure was performed: "left arm av graft catheter angiogram, maintenance balloon angioplasty with an 8x8 balloon along the course of the graft and ultrasound-guided marking of the access site with a permanent sharpie" for malfunctioning graft.The surgeon notes "the backflush angiogram showed the artery to be widely patent.There are some small vessel diseases in the hand.The catheter portion is shown to be widely patent.I used the ultrasound and marked with a permanent sharpy the access site, and i believe that there are couple of areas where it is a little deep, and i think that with the access marked, the dialysis nurses will be able to stick it better, and i think they will have success." on (b)(6) 2015 the following procedure was performed: "arch arteriogram, left upper extremity arteriogram, primary stenting left proximal brachial distal axillary artery with a 6mm x 40mm cordis smart control balloon expandable stent post dilated with a 5mm balloon" for "ischemic left arm vascular steal syndrome, esrd [end-stage renal disease]." all procedures were successful.Additionally, the patient clinical history from (b)(6) 2015 was summarized as follows (which includes the reported events of the initial complaint investigation): "this is a complexed patient with post ischemic neuropathy and probable posttraumatic neuropathy left upper extremity with vascular steal syndrome.She has recurrent left upper arm av graft, which is a hero device.She has had a miller procedure [for the steal syndrome on (b)(6) 2014], which resulted initially in improvement of hand perfusion with a palpable radial artery pulse and no significant steal by arterial pvl [peripheral vascular lab] testing." manufacturing records for lot 0001946 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero patient was implanted with a hero graft on (b)(6) 2014.As previously reported, the patient experienced steal syndrome on (b)(6) 2014 and was treated with a miller banding procedure, which restored flow.In (b)(6) 2015 the patient had another case of steal syndrome which was explored with an angiogram; severe stenosis of the distal aspect of the axillary and proximal aspect of the brachial artery was noted.This area was stented with a 6 mm x 40 mm cordis smart control balloon stent.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero and 3.8% in avg.Steal syndrome is not unique to hero graft and is a well-known complication of arteriovenous (av) access conduits (fistula, prosthetic, biologic and xenograft inclusive).Banding procedures are well established treatments to relieve steal syndrome and reestablish vascular access, as was done in (b)(6) 2014.The patient had several issues with a "malfunctioning" hero graft.In (b)(6) 2015 the patient had an angioplasty to treat stenosis (60%) before the connector portion of the graft.In (b)(6) 2015 the patient was brought in for another angiogram and maintenance angioplasty after the dialysis nurse reported an issue with inadequate graft access.At this time the graft was found to be "widely patent." the surgeon noted that "there was some scar near where the graft was placed, and they were having difficulty sticking because of that." partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft ifu.Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Patient medical history is limited to prescriptions for coumadin, plavix and asa; it is unclear if the patient was compliant with medication.The specific relationship between the hero graft and the reported steal syndrome and graft occlusion cannot be assessed at this time without additional information.

Event Description

According to the report, documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was "miller procedure & a".The outcome was listed as flow restored.Additional information was received which indicated two interventions were performed.The "reason for intervention" was listed as "unknown" and the "type of intervention" was listed as "unknown." the outcomes were listed as "flow restored.".

Event Description

According to the report, documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was "miller procedure & a." the outcome was listed as flow restored.

Manufacturer Narrative

According to the report, documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was "miller procedure & a".The outcome was listed as flow restored.Additional information was received which indicated two interventions were performed.The "reason for intervention" was listed as "unknown" and the "type of intervention" was listed as "unknown." the outcomes were listed as "flow restored." this investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report, documentation of hero graft intervention on 1 month follow-up form in the hero registry.Hero graft implanted on (b)(6) 2014.Reason for intervention was documented as steal and the type of intervention was "miller procedure & a".The outcome was listed as flow restored.Additional information was received which indicated two interventions were performed.The "reason for intervention" was listed as "unknown" and the "type of intervention" was listed as "unknown." the outcomes were listed as "flow restored.".

• 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: 4816156
• MDR Text Key: 5926907
• Report Number: 1063481-2015-00071
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2015

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
• Device Lot Number: 0001946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/22/2015; 12/04/2015
• 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: 61 YR