MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; 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	09/04/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) year old male patient underwent an endovascular aneurysm repair (evar) procedure with a zenith abdominal aortic aneurysm endovascular graft main body.During the procedure, blood leaked from the hemostatic valve.The procedure was completed without any further treatment due to the leakage.Additionally, it was reported that the patient experienced no adverse effects.This case is related to medwatch with mfr number 1820334-2017-00691 as they occurred in the same procedure.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.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.Design verification includes pressurized leak testing.In addition, the ifu provides instructions to inform users to proactively monitor blood loss during the procedure and provide instructions to effectively deal with leakage through the valve.Based on the information provided and the results of our investigation, the root cause was determined likely to be manufacturing-related.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that a (b)(6) year old male patient underwent an endovascular aneurysm repair (evar) procedure with a zenith abdominal aortic aneurysm endovascular graft main body and zenith flex with spiral-z technology aaa endovascular graft iliac leg.During the procedure, blood leaked from the hemostatic valve.The procedure was completed without any further treatment due to the leakage.Additionally, it was reported that the patient experienced no adverse effects.This case is related to medwatch number 1820334-2017-00691 as they occurred in the same procedure.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6500733
• Report Number: 1820334-2017-00683
• Device Sequence Number: 19149595
• Product Code: MIH
• UDI-Device Identifier: 10827002552392
• UDI-Public: (01)10827002552392(17)180416(10)5789670
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• 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: ZSLE-16-90-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 04/18/2017
• 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: 75 DA