MAUDE Adverse Event Report: HEMOSPHERE, INC. HERO GRAFT; VASCULAR GRAFT - PROSTHESIS

Model Number HERO 1001

Device Problems Entrapment of Device (1212); Kinked (1339); Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 04/16/2014

Event Type  Injury  

Event Description

According to the report, the surgeon recently saw a fibrin accumulation around the beaded section of the arterial graft component and decided to explant and replace it.The surgeon thinks the beaded section of the agc is possibly an area of turbulence that contributes to the product clotting with fibrin accumulation.The sample was reviewed on (b)(6) 2014.An accumulation of fibrin was noted on the inner lumen of the graft component, adjacent to the beading.A clot was noted in the connector.The graft appeared to have been incorporated and kinked at about a 45 degree angle.The beading appeared to be the previous style.Additional information was received from the surgeon in the form of operative notes.The hero graft was implanted on (b)(6) 2012 using lot numbers 0001705(hero 1001) and 0001707 (hero 1002).On (b)(6) 2013 the patient presented with a clotted hero.The voc had migrated into the right ventricle.It was completely declotted using "the cleaner device" without difficulty and angioplasty of the venous cannulation portion.It was then decided there was a need to revise the hero.A cutdown was then done in the deltopectoral grove where the catheter itself shortened appropriately such that they had appropriate lie in the mid third of the right atrium.Repeat angiograms showed excellent flow.On (b)(6) 2014 the patient presented with a repeated clotted hero.An embolectomy catheter was used proximal and distal to declot the outflow and inflow components.There as "great concern" adjacent to the connector at the shoulder area.The old connector was removed and a new connector placed with the short segment of the hero graft.Tunnelling of flixene graft was then performed and an end to end anastomosis to the arterial stump and also to the graft of the inflow component of the area.Since it is unknown which component, if any, attributed to the event it has been decided to investigate both.This medwatch is for hero 1001 product code.

Manufacturer Narrative

According to the report, the surgeon recently saw a fibrin accumulation around the beaded section of the arterial graft component and decided to explant and replace it.The surgeon thinks the beaded section of the agc is possibly an area of turbulence that contributes to the product clotting with fibrin accumulation.The sample was reviewed on (b)(4) 2014.An accumulation of fibrin was noted on the inner lumen of the graft component, adjacent to the beading.A clot was noted in the connector.The graft appeared to have been incorporated and kinked at about a 45 degree angle.The beading appeared to be the previous style.Additional information was received from the surgeon in the form of operative notes.The hero graft was implanted on (b)(6) 2012 using lot numbers 0001705(hero 1001) and 0001707 (hero 1002).On (b)(6) 2013 the patient presented with a clotted hero.The voc had migrated into the right ventricle.It was completely declotted using "the cleaner device" without difficulty and angioplasty of the venous cannulation portion.It was then decided there was a need to revise the hero.A cutdown was then done in the deltopectoral grove where the catheter itself shortened appropriately such that they had appropriate lie in the mid third of the right atrium.Repeat angiograms showed excellent flow.On (b)(6) 2014 the patient presented with a repeated clotted hero.An embolectomy catheter was used proximal and distal to declot the outflow and inflow components.There as "great concern" adjacent to the connector at the shoulder area.The old connector was removed and a new connector placed with the short segment of the hero graft.Tunnelling of flixene graft was then performed and an end to end anastomosis to the arterial stump and also to the graft of the inflow component of the area.Both thrombotic episodes were successfully treated by thrombectomy.The migration was successfully treated via surgical revision which included shortening of the venous outflow component (voc).Finally, the revision was completed by surgical explant of the hero avg/connector with replacement of a new segment of avg/connector to the previously implanted voc.Dr.Ross dictated that a flixene graft was also placed at this time connected to the arterial (avg) stump and the new avg/connector.Thrombosis is the most common cause of vascular access dysfunction and potential complication listed in the hero graft instructions for use (ifu).Graft occlusion is a known potential complication of the hero device, and reflective of the "patency" data that is reported in the clinical literature.Gibson, et.Al., report that a history of hemodialysis access thrombosis was associated with an 81% increase in risk of primary access failure and 2.56 times the risk of secondary failure.(1) as such it is not unexpected that this patient experienced multiple thrombotic episodes.Gage, et.Al., report 60% primary patency at 6 months, with loss of patency occurring as early as the first post-operative month.(2) given this patient's first thrombotic episode did not occur until 9 months after implant, many clinicians would consider this a success, especially since patency was restored with intervention.Graft kinking and/or device migration would both impact the blood flow hemodynamics through the device; as such it is plausible that either or both of these events may have contributed to the thrombotic episodes.Given the anatomic placement of the device in the shoulder area, it is possible that repetitive arm movements and/or implant technique could contribute to the kinking and/or the device migration.Additionally, the beading design on the avg has been changed to be more resistant to kinking in the region near the connector.The avg associated with this event was of the earlier design, and therefore may have contributed to this event.The ifu lists vascular graft revision/replacement, partial stenosis or full occlusion, kinking and device migration potential complications with the use of the hero graft.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT - PROSTHESIS
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4348450
• MDR Text Key: 5204620
• Report Number: 3006945290-2014-00106
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• 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: 0001705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2014
• 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): Other