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U.S. Department of Health and Human Services

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

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CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT Back to Search Results
Model Number HERO 1001
Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Thrombosis (2100); No Code Available (3191)
Event Date 07/18/2015
Event Type  Death  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
Event Description
According to the report, hero patient, (b)(6) experienced following events and were reported on the follow-up forms which have been entered thus far.On (b)(6) 2013 first hero graft implant, left upper extremity.On (b)(6) 2013 "chronic weeping syndrome at arterial anastomosis of lue (left upper extremity) hero", "large solid lump noted at arterial anastomosis." on (b)(6) 2014 "large left frontal intraparenchymal hemorrhage with surrounding vasogenic edema, herniation syndrome status post left frontal craniotomy for evacuation of large frontal clot" (coumadin stopped), seizure.On (b)(6) 2014 "semi-code in dialysis" resuscitated with cpr.(on b)(6) 2014 "fever of unknown origin," blood cultures negative.On (b)(6) 2014 "fistula malfunction with a fistula thrombectomy." on (b)(6) 2014 thrombosis and thrombectomy.On (b)(6) 2014 second hero graft implant, left side.On (b)(6) 2015 kidney transplant.At 12-month follow-up (implant 2).On (b)(6) 2015 ftt (failure to thrive).On (b)(6) 2015 dehydration, gi bleed, hypotension, "ftt." on (b)(6) 2015 multisystem organ failure, monomorphic post-transplant lymphoproliferative disorder, death.The scope of the investigation will include both hero 1001 and 1002 components byt will be reported under hero 1001.
 
Manufacturer Narrative
According to the report, hero patient, (b)(6) experienced following events and were reported on the follow-up forms which have been entered thus far.On (b)(6) 2013 first hero graft implant, left upper extremity.On (b)(6) 2013 "chronic weeping syndrome at arterial anastomosis of lue (left upper extremity) hero", "large solid lump noted at arterial anastomosis".On (b)(6) 2014 "large left frontal intraparenchymal hemorrhage with surrounding vasogenic edema, herniation syndrome status post left frontal craniotomy for evacuation of large frontal clot" (coumadin stopped), seizure.On (b)(6) 2014 "semi-code in dialysis" resuscitated with cpr.On (b)(6) 2014 "fever of unknown origin," blood cultures negative.On (b)(6) 2014 "fistula malfunction with a fistula thrombectomy".On (b)(6) 2014 thrombosis and thrombectomy.On (b)(6) 2014 second hero graft implant, left side.On (b)(6) 2015 kidney transplant.At 12-month follow-up (implant 2).On (b)(6) 2015 ftt (failure to thrive).On (b)(6) 2015 dehydration, gi bleed, hypotension, "ftt", on (b)(6) 2015 multisystem organ failure, monomorphic post-transplant lymphoproliferative disorder, death.The scope of the investigation will include both hero 1001 and 1002 components but will be reported under hero 1001.A definitive lot number for the initial hero 1002 implant was unavailable.As date of implant is known ((b)(6) 2013), the system was queried for potential lots shipped to the hospital in the six months prior to implant.The following potential hero 1002 lots were returned: 0001805, 0001808, 0001794, 0001834, and 0001850.The manufacturing records for lots 0001771, 0001805, 0001808, 0001794, 0001834, and 0001850 for implant 1, and h14vc023 and h14av011 for implant 2, 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 two hero grafts, one on (b)(6) 2013 and the second on (b)(6) 2014.The first graft was implanted with a brachiai arterial anastomosis and the venous access point was the subclavian vein; the hero graft was anastomosed to a flixene graft.The first date of cannulation was (b)(6) 2013.The second graft was implanted with an existing arteriovenous graft (avg) anastomosis (flixene) and the venous access point was the subclavian vein.The first date of cannulation was (b)(6) 2014.The patient's pre-existing medical conditions include the following: deep vein thrombosis (dvt), gastroesophageal reflux disease, nephrotic syndrome, and end stage renal disease.The patient also had a history of chronic coumadin use due history of dvt.The first adverse event reported within the first hero graft period was chronic weeping on (b)(6) 2013.The patient presented with a large solid lump, which was described as a large fluid collection with solid material present.The patient was asymptomatic and there was no evidence of infection.The surgeon chose to not intervene and monitor it.Seromas have been reported with both dacron and polytetrafluoroethylene (ptfe) grafts, most commonly when they are placed in subcutaneous locations and are sometimes referred to as a weeping graft.Seromas are listed on the hero graft instructions for use (ifu) as potential vascular graft and catheter complications.The patient reported that the lump first presented following surgery and it eventually stopped growing (over the year post-op).The relationship between the hero graft and the weeping cannot be determined without additional information provided from the surgeon post-implant.However, most likely there was weeping of the flixene graft rather than a complication of the hero graft components.The note provided one year after the implant did not indicate what may have occurred.On (b)(6) 2014 the patient was admitted to the hospital with an altered mental state and a headache.The patient was diagnosed with a large left frontal intraparenchymal hemorrhage with surrounding vasogenic edema and herniation syndrome status post left frontal craniotomy for evacuation of large frontal clot.The patient's chronic coumadin therapy was stopped.The patient also suffered a seizure during hospitalization.The cause of the seizure was not documented.As previously stated, the patient had a history of clotting and was specifically described as "prone to vascular and deep vein thrombosis in past requiring coumadin use." the hero graft was not implicated as the source of the patient's hemorrhage in the patient's work up; therefore there is no documented relationship between the hero graft and this event.The patient had two thrombosis events documented during the first hero graft implant period.The patient had a graft thrombosis, which simultaneously presented with the brain hemorrhage in (b)(6) 2014.The graft was also reported to require a thrombectomy in (b)(6) 2014 (exact date is unknown).Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (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.The specific relationship between the thrombosis/occlusion events and the hero graft was not documented; additional information is needed to determine this relationship.However, as previously stated, the patient was prone to thrombosis events.The patient was hospitalized on (b)(6) 2014 after craniotomy for a fever.The patient had also semi-coded while receiving dialysis two days prior.No infection was found during the patient's work up and the source of the fever was not documented.The relationship between the patient's fever and the hero graft cannot be determined by the information provided.As previously stated, there was no evidence that the hero graft was infected and cultures were negative.The patient had multiple complications after kidney transplant on (b)(6) 2015.On (b)(6) 2015 the patient was admitted for a stricture of the transplant ureter; a percutaneous nephrostomy was placed.On (b)(6) 2015 the patient was admitted again for dehydration, failure to thrive (ftt), history of kidney transplant, and hematochezia.Of note, the patient's graft function was documented as "good." on (b)(6) 2015 the patient had an episode of lower gastrointestinal bleed associated with hypotension; colonoscopy followed and colonic/ ileai biopsies came back as monomorphic post-transplant lymphoproliferative disorder (ptld, diffuse large b-cell lymphoma), ebv-positive (ebstein-barr virus).His condition rapidly deteriorated and had severe epistaxis, requiring vasopressors.Management of the patient's ptld continued.However, the patient's condition deteriorated and life sustaining therapy was discontinued.The patient died on (b)(6) 2015.The official cause of death was not documented; however, the hero graft was not implicated as the cause of the patient's death or in the events leading up to the death, including all kidney transplant complications.Therefore, there is no documented relationship between the hero graft and the aforementioned events.The patient reported here had a procedure modification to include flixene graft attached to the arterial graft component, with the venous access in the subclavian position.The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with a flixene graft have not been evaluated by cryolife.However, the flixene 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, hero patient, (b)(6) experienced following events and were reported on the follow-up forms which have been entered thus far.On (b)(6) 2013 first hero graft implant, left upper extremity.On (b)(6) 2013 "chronic weeping syndrome at arterial anastomosis of lue (left upper extremity) hero", "large solid lump noted at arterial anastomosis".On (b)(6) 2014 "large left frontal intraparenchymal hemorrhage with surrounding vasogenic edema, herniation syndrome status post left frontal craniotomy for evacuation of large frontal clot" (coumadin stopped), seizure.On (b)(6) 2014 "semi-code in dialysis" resuscitated with cpr.On (b)(6) 2014 "fever of unknown origin," blood cultures negative.On (b)(6) 2014 "fistula malfunction with a fistula thrombectomy".On (b)(6) 2014 thrombosis and thrombectomy.On (b)(6) 2014 second hero graft implant, left side.On (b)(6) 2015 kidney transplant.At 12-month follow-up (implant 2).On (b)(6) 2015 ftt (failure to thrive).On (b)(6) 2015 dehydration, gi bleed, hypotension, "ftt", on (b)(6) 2015 multisystem organ failure, monomorphic post-transplant lymphoproliferative disorder, death.The scope of the investigation will include both hero 1001 and 1002 components byt will be reported under hero 1001.
 
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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 Key5403869
MDR Text Key37307492
Report Number1063481-2016-00010
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/14/2016
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 NumberHERO 1001
Device Lot Number0001771, H14VC023, H14AV011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/02/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/19/2016
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 Number1
Patient Outcome(s) Death;
Patient Age71 YR
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