• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT Back to Search Results
Model Number HERO 1001
Device Problem Occlusion Within Device (1423)
Patient Problems High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Occlusion (1984); Reocclusion (1985); Thrombosis (2100); No Code Available (3191)
Event Type  Injury  
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 publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 001.Patient 001 was a female who received a hero implant on (b)(6) 2011.They required the following vascular interventions: thrombectomy on (b)(6) 2011 for unknown reasons, thrombectomy/angioplasty on (b)(6) 2011, (b)(6) 2012, and (b)(6) 2012 for clotting and full hero graft occlusion.
 
Manufacturer Narrative
According to the publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 001.Patient 001 was a female who received a hero implant on (b)(6) 2011.They required the following vascular interventions: thrombectomy on (b)(6) 2011 for unknown reasons, thrombectomy/angioplasty on (b)(6) 2011, (b)(6) 2012 for clotting and full hero graft occlusion.The manufacturing records for lots 0001316 and 0001324 were reviewed by quality assurance/quality control (qa/qc), and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient had four interventions to treat hero graft clotting and occlusion while on study; the patient had a thrombectomy in (b)(6) 2011 and three thrombectomy/angioplasty procedures between (b)(6) 2011 and (b)(6) 2012.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 hero graft and the interventions cannot be assessed at this time based on the limited available information.A definitive root cause for the reported events cannot be determined, however, thrombosis/occlusion are known potential complications of all av grafts.
 
Event Description
According to the publication, "prospective analysis of hemodialysis reliable outflow vascular access graft vs.Cuffed catheter access in hemodialysis," the prospective cohort study assessed clinical outcomes in 16 hero graft patients against a control group without hero (n=17) over one year.The adverse events associated with each patient are being reported collectively per patient as a determination could not be made regarding the relation of the associated events.Furthermore, the specific patient comorbidities and contributory factors for the reported adverse events cannot be correlated.The most common etiology of end-stage renal disease (esrd) was diabetes, hypertension, or the combination of both.The most common comorbidities in both study groups were diabetes mellitus, hypertension, and myocardial infarction.This medwatch is being submitted as product code hero 1001, however the scope of the investigation will evaluate both hero 1001 and hero 1002 components.This report is being submitted for patient 001.Patient 001 was a female who received a hero implant on (b)(6) 2011.They required the following vascular interventions: thrombectomy on (b)(6) 2011 for unknown reasons, thrombectomy/angioplasty on (b)(6) 2011, (b)(6) 2012 for clotting and full hero graft occlusion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5031058
MDR Text Key24065727
Report Number1063481-2015-00152
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,use
Reporter Occupation Physician
Report Date 07/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberHERO 1001
Device Lot Number0001316, 0001324
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) Hospitalization; Other;
-
-