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

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.

• 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: 5410030
• MDR Text Key: 37452302
• Report Number: 1063481-2016-00014
• 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: 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 Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2016; 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 Number: 1
• Patient Outcome(s): Other