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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 1002
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Event Description
According to the report, the "implant was done without problem but in the hours after the patient develop a steel syndrome and hero had to be explanted.In the history of this patient a tentative to implant a ptfe graft was done previously and at that time patient did also develop a steel syndrome and prosthesis was explanted.After that he had catheter.Hero was his last chance to get away from catheter.And even if physician know that a steel syndrome was not excluded they wanted to try hero implant by this patient.".
 
Manufacturer Narrative
The exact dates are unknown.However, it is known that the representative was aware "a few weeks after the implant," which was at the end of (b)(6) 2015, so the dates are approximated to (b)(6) 2015.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Manufacturer Narrative
(b)(4).According to the report, the "implant was done without problem but in the hours after the patient develop a steel syndrome and hero had to be explanted.In the history of this patient a tentative to implant a ptfe graft was done previously and at that time patient did also develop a steel syndrome and prosthesis was explanted.After that he had catheter.Hero was his last chance to get away from catheter.And even if physician know that a steel syndrome was not excluded they wanted to try hero implant by this patient." the surgeon's presentation was requested for review, however it was not provided as the cryolife representative "check[ed] the presentation with dr.(b)(6) (the fellow who did the presentation at swiss surgery congress).There is no mention of this case in the slide; it was only in his talk that he mentioned that one patient had surgery again because of this steal syndrome.Dr.(b)(6) said again that it was not first time this patient had a steal syndrome and that there was no failure of hero." the manufacturing records for lot h14av022 were reviewed and it was confirmed that all records were controlled, availoable for review, and met all specifications per the device master record.A review was performed of the available information.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 arteriovenous grafts (avg).Steal syndrome is not unique to the hero graft and is a well-known complication of arteriovenous (av) access conduits; fistula, prosthetic, biologic and xenograft inclusive.This patient had a history of steal syndrome in a previous expanded polytetrafluoroethylene (eptfe) graft.Considering this patient's history of steal, graft explant was chosen as the treatment option to relieve steal syndrome.It is unclear if an alternative surgical intervention was attempted prior to explant.The surgeons stated that they believed the steal syndrome was not a result of the hero but was related to the patient's history.Additional information on patient history was not available.This complication does not reflect a defect in the device itself.Adequate precautions are provided in the instructions for use.
 
Event Description
According to the report, the "implant was done without problem but in the hours after the patient develop a steel syndrome and hero had to be explanted.In the history of this patient a tentative to implant a ptfe graft was done previously and at that time patient did also develop a steel syndrome and prosthesis was explanted.After that he had catheter.Hero was his last chance to get away from catheter.And even if physician know that a steel syndrome was not excluded they wanted to try hero implant by this patient.".
 
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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
sandra o'reilly
1655 roberts blvd., nw
kennesaw, GA 30144
7704193355
MDR Report Key4801744
MDR Text Key5894475
Report Number1063481-2015-00070
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K124039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberHERO 1002
Device Lot NumberH14AV022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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) Other;
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