MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED GRAFT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32544
Health Effect - Clinical Codes	Dyspnea (1816); Blood Loss (2597)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00017.
Event or Problem Description
Delivery system began leaking extensively at the white plastic assembly where the trigger wire release are mounted.Patient lost extensive amount of blood and pressure crashed.It was attempted to reduce blood loss from leaking area, drugs was administered to increase blood pressure and an occlusion balloon was repeatedly inflated & deflated to occlude aorta.Patient lost 1.5 liters of blood.
Additional Manufacturer Narrative
This report relates to report 9680654-2017-00017.
Event or Problem Description
Delivery system began leaking extensively at the white plastic assembly where the trigger wire release are mounted.Patient lost extensive amount of blood and pressure crashed.It was attempted to reduce blood loss from leaking area, drugs was administered to increase blood pressure and an occlusion balloon was repeatedly inflated & deflated to occlude aorta.Patient lost 1.5 liters of blood.07 august 17 update: patient lost 2.7 liters of blood and was near cardiac arrest.The patient anatomy was technically easy and the endovascular segment was able to be complete in 20 minutes until the delivery system could be exchanged.
Additional Manufacturer Narrative
Additional information was received noting that the device was supplied under a physician sponsored ide.Additional information was received noting that the device was supplied under a physician sponsored ide.
Event or Problem Description
Delivery system began leaking extensively at the white plastic assembly where the trigger wire release are mounted.Patient lost extensive amount of blood and pressure crashed.It was attempted to reduce blood loss from leaking area, drugs was administered to increase blood pressure and an occlusion balloon was repeatedly inflated & deflated to occlude aorta.Patient lost 1.5 liters of blood.07 august 17 update: patient lost 2.7 liters of blood and was near cardiac arrest.The patient anatomy was technically easy and the endovascular segment was able to be complete in 20 minutes until the delivery system could be exchanged.

• Brand Name: ZENITH FENESTRATED GRAFT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 6727201
• Report Number: 9680654-2017-00016
• Device Sequence Number: 881616
• Product Code: MIH
• UDI-Device Identifier: 10827002325446
• UDI-Public: (01)10827002325446(17)200222(10)AC990274
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Health Professional
• Device Model Number: G32544
• Device Catalogue Number: FEN-THORACO-ABDOMINAL-GRAFT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017; 07/12/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/20/2017; 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1