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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 Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
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, a surgeon reported at a meeting that was held during the cida conference the following information related to the hero graft: the jvir publication recently issued an article regarding the migration of the venous outflow component (voc) to the inferior vena cavae (ivc).He did not have the specifics.He also said that there is a problem with any catheter migrating in general.As of now, the publication cannot be located via pubmed or (b)(4) scholar literature searches or via review of recent jvir table of contents.
 
Manufacturer Narrative
According to the report, a surgeon reported at a meeting that was held during the cida conference the following information related to the hero graft: the jvir publication recently issued an article regarding the migration of the venous outflow component (voc) to the inferior vena cavae (ivc).He did not have the specifics.He also said that there is a problem with any catheter migrating in general.As of now, the publication cannot be located via pubmed or google scholar literature searches or via review of recent jvir table of contents.Attempts to obtain additional clarifying information were unsuccessful.A phone call was made to the physicians office on (b)(6) 2015 but he was unavailable to speak.Contact information was provided to the office nurse.The physician left a voicemail with cryolife on the evening of (b)(6) 2015 stating that he was returning a previous phone call.A return phone call was made on (b)(6) 2015 in which the physician was again unavailable.A request for his email address was denied by the nurse and contact information was provided again.No return phone call from the physician was received.A final follow-up letter was mailed to the physician on (b)(6) 2015 but a response was not received.If additional information is received, it will be re-evaluated and the complaint will be reopened.The manufacturing records were not reviewed as definitive lot numbers are unavailable and dates of implant are unknown.The system cannot be queried for potential lots shipped to the hospital without knowing implant dates.The physician reported during the cida (controversies in dialysis access) conference meeting on (b)(6) 2015 that a jvir (the journal of vascular and interventional radiology) publication recently issued an article regarding the migration of the hero graft voc to the ivc.He did not have specifics.He also said that there is a problem with any catheter migrating in general.The publication was located through pubmed or google scholar literature searches or review of the recent jvir table of contents.Device migration is listed in the hero graft instructions for use (ifu) as a potential vascular graft and catheter complication.Directions on how to place the hero graft are provided in the ifu.Without case specific information, no relationship can be determined between the hero graft and the reported events.
 
Event Description
According to the report, a surgeon reported at a meeting that was held during the cida conference the following information related to the hero graft: the jvir publication recently issued an article regarding the migration of the venous outflow component (voc) to the inferior vena cavae (ivc).He did not have the specifics.He also said that there is a problem with any catheter migrating in general.As of now, the publication cannot be located via pubmed or google scholar literature searches or via review of recent jvir table of contents.
 
Manufacturer Narrative
According to the report, a surgeon reported at a meeting that was held during (b)(6) the following information related to the hero graft: the jvir publication recently issued an article regarding the migration of the venous outflow component (voc) to the inferior vena cavae (ivc).He did not have the specifics.He also said that there is a problem with any catheter migrating in general.As of now, the publication cannot be located via pubmed or google scholar literature searches or via review of recent jvir table of contents.Attempts to obtain additional clarifying information were unsuccessful.A phone call was made to the physicians office on 11/11/2015 but he was unavailable to speak.Contact information was provided to the office nurse.The physician left a voicemail with cryolife on the evening of 11/11/2015 stating that he was returning a previous phone call.A return phone call was made on 11/12/2015 in which the physician was again unavailable.A request for his email address was denied by the nurse and contact information was provided again.No return phone call from the physician was received.A final follow-up letter was mailed to the physician on 11/25/2015 but a response was not received.If additional information is received, it will be re-evaluated and the complaint will be reopened.The manufacturing records were not reviewed as definitive lot numbers are unavailable and dates of implant are unknown.The system cannot be queried for potential lots shipped to the hospital without knowing implant dates.The physician reported during the (b)(6) conference meeting on 10/30/2015 that a jvir (the journal of vascular and interventional radiology) publication recently issued an article regarding the migration of the hero graft voc to the ivc.He did not have specifics.He also said that there is a problem with any catheter migrating in general.The publication was located through pubmed or google scholar literature searches or review of the recent jvir table of contents.Device migration is listed in the hero graft instructions for use (ifu) as a potential vascular graft and catheter complication.Directions on how to place the hero graft are provided in the ifu.Without case specific information, no relationship can be determined between the hero graft and the reported events.
 
Event Description
According to the report, a surgeon reported at a meeting that was held during the (b)(6) conference the following information related to the hero graft: the jvir publication recently issued an article regarding the migration of the venous outflow component (voc) to the inferior vena cavae (ivc).He did not have the specifics.He also said that there is a problem with any catheter migrating in general.As of now, the publication cannot be located via pubmed or google scholar literature searches or via review of recent jvir table of contents.
 
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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 Key5410030
MDR Text Key37452302
Report Number1063481-2016-00014
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
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/29/2015
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 NumberHERO 1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received02/15/2016
02/16/2016
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) Other;
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