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

Model Number HERO 1001

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Note: this mdr is being re-sent to mark g7 as initial.This investigation is currently ongoing.Any add'l info will be provided in the f/u report.

Event Description

According to the report from the rep, he spoke with the surgeon "on (b)(6)2015 and he stated that he had connected the outflow component to the arterial component and started to tunnel the graft when the arterial graft component pulled off of the connector." the scope of the investigation will include both hero 1001 and 1002 components but will be submitted under hero 1001.

Manufacturer Narrative

According to the report from the rep, he spoke with the surgeon "on 10/21/2015 and he stated that he had connected the outflow component to the arterial component and started to tunnel the graft when the arterial graft component pulled off of the connector." the returned venous outflow component (voc) and arterial graft component (agc) were returned on 11/06/2015.Included with the returned sample were the hero 1001 and 1002 product boxes which indicated that the associated lots were h15vc024 and h15av010.The voc and agc were returned within a biohazard bag.The components were removed and visually inspected both grossly and under magnification.The voc and agc were returned disconnected, with the titanium connector embedded into the end of the voc and completely removed from the end of the agc where it is normally attached.This end of the agc, proximal to the connector and past the beading, exhibited a clean, square cut with no evidence of tearing.This end of the agc would have allowed enough space for adequate clamping by the crimping ring.Beneath the clear silicone sleeve of the titanium connector, the crimping ring contained the crimping ears which indicated that this component was crimped.However, no obvious witness marks made by the crimping ring could be observed on the agc.A small tear was noted at the anastomotic end of the agc.The voc was not completely engaged onto the connector and a small space was evident between the end and the connector lip, which may be evidence of an applied mechanical force which caused the breakage at the agc connection.The marker band on the voc was crushed, further indicating the application of mechanical force to the voc during implant.No additional information, including details of the implant technique, were received from the rep which would have indicated a reason for these observations in the graft.The manufacturing records for lots h15vc024 and h15av010 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.

Event Description

According to the report from the rep, he spoke with the surgeon "on 10/21/2015 and he stated that he had connected the outflow component to the arterial component and started to tunnel the graft when the arterial graft component pulled off of the connector." the scope of the investigation will include both hero 1001 and 1002 components but will be submitted under hero 1001.

• 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: 5460006
• MDR Text Key: 83878913
• Report Number: 1063481-2015-00348
• 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
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H15AV010, H15VC024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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