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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	05/16/2017
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 2 years after a standard endovascular aneurysm repair (evar) with a zenith flex with spiral-z technology aaa endovascular graft iliac leg, a clot was discovered in the patient's left common iliac (zsle-20-74-zt).There is also 3 final run pics of the initial evar procedure 2 years ago and one showing the recent limb occlusion, which seems to occur at the distal sealing zone of the zsle.The limbs in the occlusion pic seems normal, not kinked or anything, and once the clot was removed, normal flow was there again.No unintended section of the device remained inside the patient's body.The patient required the additional procedures, thrombolosys and embolectomy.Additionally, it was reported that the product caused acute limb ischemia.
Additional Manufacturer Narrative
The focus of the complaint is a zsle-20-74-zt implanted in the left iliac during evar.Two years after the procedure a clot was discovered in the left iliac with acute limb ischemia.Thrombolysis and embolectomy were performed to fix the clot.A review of documentation, instructions for use, manufacturing instructions and quality controls were conducted during this investigation.The product was not returned and therefore a device evaluation could not be performed.Four angiography image captures are provided along with the complaint report.The first three ¿intraop¿ images are reportedly from the completion imaging at the time of endovascular aneurysm repair 2 years prior.Occlusions can be caused by damage to the stents or sutures causing lumen reduction, a hypercoagulable state, kinks, tortuous anatomy, or misdeployment.Four angiography images were provided for image review.The intraoperative angio found no significant angulation, tortuosity, or kink, and the left iliac is "widely patent." a second and third intraoperative angio confirmed the findings of the first angio.The fourth image labeled, "occlusion" found, "this image looks like a complete occlusion of the distal left iliac leg." in that image there is no evidence of kinking, stent damage, or stenosis.The patient's previous medical information was not supplied so a risk of clotting can not be determined.Based on the anatomy, lack of kink or stenosis, and lack of patient information the root cause of the occlusion can not be determined.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6661198
• Report Number: 1820334-2017-01376
• Device Sequence Number: 16195658
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)160901(10)4487496
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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-20-74-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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