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	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported that during the repair of an abdominal aortic aneurysm (aaa) on the (b)(6) male patient, using a zenith flex aaa endovascular graft bifurcated main body, the valve on the sheath leaked throughout the duration of the procedure.The procedure was completed with the complaint device; however, there was some blood loss during the procedure, although the exact amount of blood loss could not be determined.It was reported that the patient did not require additional blood products.
Additional Manufacturer Narrative
A review of complaint history, device history record, quality control data, and visual inspection of the returned device was conducted during the investigation.A physical evaluation of the returned complaint device was performed in the lab, during which a table top leak test was performed.A dilator in the lab with an occluded tip was used to aid in the leak testing.It was noted that the device did not indicate any leak with the dilator inserted and no tears were present in the silicone discs or iris valve.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation; a definitive root cause could not be determined, measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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: 6450119
• Report Number: 1820334-2017-00507
• Device Sequence Number: 615143
• Product Code: MIH
• UDI-Device Identifier: 10827002484075
• UDI-Public: (01)10827002484075(17)180324(10)6825532
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-24-82-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 DA