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

Model Number HERO 1001

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Arrhythmia (1721); Palpitations (2467)

Event Date 11/30/2014

Event Type  Injury  

Manufacturer Narrative

According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the third of four patients.According to the surgeons, "the third patient on which we performed revision after hero graft implantation was a (b)(6) woman.She received the hero graft on (b)(6) 2014, the revision was performed on (b)(6) 2014.The indication for the revision was heart arrhythmia and palpitations that were perceived as very disturbing by the patient.At the revision, the venous outflow component of the hero graft was shortened.We thought that the intravascular end of the hero graft lay too deep in the right atrium, thus causing the arrhythmia.After the shortening of the catheter the complaints of the patient were gone." the manufacturing records for lot h14vc041 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.At this time, the role of the hero graft in these revisions cannot be determined with the available information, although graft revision/replacement is an established treatment for arteriovenous (av) graft complications.Cardiac arrhythmia is listed in the hero ifu as a potential intraoperative and post-operative complication.In this case of arrhythmia and palpitations, the symptoms appeared three days post-implantation.The surgeon stated that the "intravascular end of the hero graft lay too deep in the right atrium." directions on how to place the device are provided in the ifu.Without operative notes or further details about the device position it is not clear how this event occurred and if there were any surgical deviations from the specified methodology.Medical history is also unknown at this time.

Event Description

According to the report, "only heard information that there had been 3 revisions on patients who previously received a hero graft." additional information was received which indicated the hospital had "performed five hero graft implantations in five patients.We have performed five revisions in four patients." this report represents the third of four patients.According to the surgeons, "the third patient on which we performed revision after hero graft implantation was a (b)(6) woman.She received the hero graft on (b)(6) 2014, the revision was performed on (b)(6) 2014.The indication for the revision was heart arrhythmia and palpitations that were perceived as very disturbing by the patient.At the revision, the venous outflow component of the hero graft was shortened.We thought that the intravascular end of the hero graft lay too deep in the right atrium, thus causing the arrhythmia.After the shortening of the catheter the complaints of the patient were gone.".

• 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: 5017508
• MDR Text Key: 23537595
• Report Number: 1063481-2015-00170
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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: H14VC041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR