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

Model Number HERO 1001

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/29/2015

Event Type  Injury  

Event Description

According to the report, "the surgeon believes that there was a successful surgery, but post-operatively, the venous outflow component seems to have pulled back or migrated to the svc (superior vena cava) from the right atrium.The surgeon believes the patient had poor venous flow and plans on replacing the venous outflow in a new surgery.".

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.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.

Manufacturer Narrative

Correct date of implant is (b)(6) 2015 and date of event is (b)(6) 2015.According to the report, "the surgeon believes that there was a successful surgery, but post-operatively, the venous outflow component (voc) seems to have pulled back or migrated to the svc (superior vena cava) from the right atrium.The surgeon believes the patient had poor venous flow and plans on replacing the venous outflow in a new surgery." additional information from the representative indicated that the original date of implantation of the hero graft (lot h15vc005) was on (b)(6) 2015.The patient was admitted to (b)(6) with av access problems on (b)(6) 2015, at this time fluoroscopy and an x-ray indicated that the voc had migrated to the svc.On (b)(6) 2015 the surgeon performed an ultrasound guided placement of a right internal jugular vein permcath to be used in the interim until the voc could be explanted.On (b)(6) 2015 the surgeon performed a surgical intervention to replace the voc with a longer component via incision into the deltopectoral groove without complication.The surgeon expressed to the representative that the original voc was not tacked down and this may have contributed to the migration along with the fact that this patient is a "pretty active (b)(6) woman".Manufacturing records for lot h14vc005 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was implanted with a left side hero graft in early (b)(6) 2015.By the end of june, the patient was hospitalized with "access failure." the presenting symptoms to indicate access failure are unclear.Fluoroscopy and x-ray indicated that the venous outflow component (voc) had migrated 6-8 cm into the superior vena cava (svc).Device migration is listed on the hero graft instructions for use (ifu) as a potential vascular graft and catheter complication.Directions on how to place the graft are provided in the ifu.Operative notes were provided for the interim catheter placement; however notes from the initial hero implant procedure were not available.Without operative notes or further details about the device repositioning it is not clear how this event occurred and if there were any surgical deviations from the specified methodology.The surgeon commented that the "patient was a pretty active (b)(6) woman" which was most likely the cause of migration.The surgeon revised the graft in mid (b)(6) by replacing the voc with a longer component via an incision into the deltopectoral groove.At the time of revision, the voc was also tacked down, the surgeon noted that the voc was not tacked down initially.At this time, the precise role of the hero graft in this case of device migration cannot be determined without operative notes and a more detailed patient history.The patient's active lifestyle may have been a contributing factor.The root cause of the reported events is unknown, however, device migration is a known complication.

Event Description

According to the report, "the surgeon believes that there was a successful surgery, but post-operatively, the venous outflow component seems to have pulled back or migrated to the svc (superior vena cava) from the right atrium.The surgeon believes the patient had poor venous flow and plans on replacing the venous outflow in a new surgery.".

• 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 Key: 4892091
• MDR Text Key: 15304050
• Report Number: 1063481-2015-00105
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2015

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
• Device Lot Number: H15VC005
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• 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): Hospitalization