MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an abdominal aneurysm repair, the check-flo hub leaked throughout the procedure.The patient experienced blood loss (approximately 300 to 400 liters).However, the procedure was completed with the complaint device.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Correction: describe event or problem) updated: device not returned.Due to the investigation of similar complaints, it is feasible to suggest that damage/tearing of the discs likely contributed to the reported leakage.At this time, the exact cause of the damage/tearing is unknown.Measures have been conducted to address this failure mode.Updated 19june2017 updated by (b)(6).
Event or Problem Description
It was reported that during an abdominal aneurysm repair, the check-flo hub leaked throughout the procedure.The patient experienced blood loss (approximately 300 to 400 milliliters).However, the procedure was completed with the complaint device.The patient did not require any additional procedures due to this occurrence.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5789655
• Report Number: 1820334-2016-00627
• Device Sequence Number: 1163590
• Product Code: MIH
• UDI-Device Identifier: 10827002484358
• UDI-Public: (01)10827002484358(17)160919(10)5283864
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-36-149-ZT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other