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

Model Number HERO 1002

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Air Embolism (1697); Thrombosis (2100); Pseudoaneurysm (2605)

Event Date 09/24/2014

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, hero patient, (b)(6), was implanted with a hero graft on (b)(6) 2009.The 30-month follow-up form reports a hospitalization for "asthma exacerbation".The 36-month follow-up form reports a percutaneous angioplasty in (b)(6) 2012.The 66-month follow-up form reports three clotting events which required percutaneous angioplasty between (b)(6) 2014 and (b)(6) of 2015.A graft pseudoaneurysm was noted on (b)(6) 2014.In (b)(6) 2015 the patient was also reported to have an acute pulmonary embolism.The 72-month follow-up form was not entered, but the coordinator e-mailed notes which document a graft revision and thrombectomy in (b)(6) 2015.The scope of the investigation will include both hero 1001 and 1002 components but will be submitted under hero 1001.

Manufacturer Narrative

The report was incorrectly submitted as a combined initial and final report for report number 1063481-2015-00008.The manufacturer's report number has been corrected to 1063481-2015-00009.

Event Description

Dr.(b)(6) saw this (b)(6) hero graft patient because the dialysis clinic thought his graft was clotted.Upon x-ray he found that the outflow component was actually broken at the area where it made contact with the clavical.The patient lifts heavy weights on a daily basis and dr.(b)(6) believes the repeated stress between the clavical and the outflow component caused the breakage.He removed the device and implanted another graft and outflow component.Initially there was no accusation of a deficiency with the hero 1002 component.Upon receipt of additional information however, it was decided that the hero 1002 component would be investigated.This medwatch represents an initial and a follow--up report for the hero 1002 component.

• 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: 4474489
• MDR Text Key: 37255562
• Report Number: 1063481-2015-00009
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

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 1002
• Device Lot Number: 0000247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening; Other
• Patient Age: 28 YR