MAUDE Adverse Event Report: MAQUET MEDICAL (GETINGE GROUP) GRAFT HEMAGARD BIFR 20X10MM

Model Number HGK2010

Device Problem Break (1069)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 09/15/2015

Event Type  Death  

Event Description

This pt was admitted for elective resection of his abdominal aortic aneurysm which was done on (b)(6) 2015.A 20x10mm intravascular bifurcation collagen impregnated graft was chosen.The new graft was then sewn in place using 4-0 prolene.Graft was tunneled retroperitoneally to the femoral areas.Total estimated blood loss was 1700 ml and the pt received 800 ml of packed cells from the cell saver.He did not require any banked blood.The morning of (b)(6) 2015, he became hypotensive.The stat ct of the abdomen showed a ct scan of the chest, abdomen and pelvis was obtained it appeared that a previously placed prolene suture was either broken or pulled out of the proximal aortic wall.He was given iv contrast and there was a blush in the retroperitoneum.The pt was emergently returned to the operating room.Abdomen was prepped and draped abdominal incision was reopened.Retroperitoneum was explored.There was slight arterial bleeding at the proximal suture line, it was identified and sutured.The pt became hypotensive, proximal aorta was crossclamped to assist with resuscitation including cardiopulmonary resuscitation and chest compression and bleeding at the proximal suture line was controlled with several 4-0 prolene suture that clamp was removed and bleeding was controlled.It appeared that a previously placed prolene suture was either broken or pulled out of the proximal aortic wall.During this time, the pt required continued chest compressions.He never responded to aggressive cpr, despite aortic crossclamp and he was pronounced dead.

• Brand Name: GRAFT HEMAGARD BIFR 20X10MM
• Type of Device: GRAFT
• Manufacturer (Section D): MAQUET MEDICAL (GETINGE GROUP); 45 barbour pond drive; wayne NJ 07950
• MDR Report Key: 5801853
• MDR Text Key: 49763145
• Report Number: MW5063446
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: HGK2010
• Device Lot Number: 15C19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 67