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 Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During a aaa procedure on the (b)(6) year old male patient, the limb looked as though it was leaking throughout the fabric; type iv endoleak.The user placed an additional limb (11 x 90) and the endoleak was fixed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Clinical opinion of the event: it was reported that a section of the device remained inside the patient¿s body and also that the patient did require an additional procedure due to this occurrence.It was also reported that the patient did not experienced any adverse effects due to this occurrence and that the outcome of the procedure was "overall successful".Due to the limited information available it is not very clear if the root cause of the event it's associated with the patient condition, the surgical procedure or an eventual malfunction of the device.A review of the device history record for this lot did not reveal any issues related to the manufacturing process of the device.Since the device was not returned for evaluation, a definitive root cause could not be determined.Review of the manufacturing records found no evidence indicating that the device was manufactured outside of manufacturer specifications.Type iv endo-leaks typically occur soon after endovascular aortic repairs due to porosity of the graft materials and the aggressively anticoagulated blood.These types of leaks usually resolve without intervention after the procedure and the anticoagulation normalizes.As no imaging was provided, the type of endo-leak and the cause cannot be stated with confidence, the root cause is unknown.Per the quality engineer risk assessment no additional risk reduction activities are required at this time.

• 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: 5637196
• Report Number: 1820334-2016-00313
• Device Sequence Number: 772765
• Product Code: MIH
• UDI-Device Identifier: 10827002552286
• UDI-Public: (01)10827002552286(17)160501(10)4244896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: N/A
• Device Catalogue Number: ZSLE-11-107-ZT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2016
• Device Age: 3 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 06/28/2017
• 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: Required Intervention
• Patient Age: 79 YR