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	G55246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); No Code Available (3191)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported a (b)(6), male zenith iliac branch graft system study patient was treated for a right common iliac aneurysm (cia) and underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2016.According to the product specialist report, the branch graft was deployed without difficulty, but when contrast was injected to define the internal iliac artery (iia), the iia was not seen.Two more injections were made with the image intensifier at different angles, but the iia could not be located in any view.The decision was made to occlude the side branch of the zbis with another manufacturer's device.The main body and the iliac legs were deployed without difficulty.A molding balloon was used without difficulty.Post-procedure angiography revealed no endoleaks.The patient was discharged from the hospital on (b)(6) 2016.Follow-up computerized tomography (ct) scans were performed at 1 month and 2 years post-procedure.According to the 2-yr follow-up ct imaging, there is 90% stenosis of the proximal left renal artery and 80% stenosis of the left common iliac artery.The site reported that this was unlikely related to the study product and was possibly related to the study procedure.On (b)(6) 2017, the patient underwent a secondary intervention procedure for placement of a stent into the left common iliac artery.
Additional Manufacturer Narrative
Concomitant products: branch graft: zbis-10-61-41 (ac943371) right eia, zenith aaa main body: tffb-32-82-zt (5205566), iliac leg graft: zsle-16-90-zt (5305895), atrium icast - not deployed, amplatzer plug (st jude medical) 9 x 12.Investigation/evaluation: the actual complaint device was not returned.Without the complaint device, a physical investigation was not able to be completed.Imaging was provided for review.A documentation investigation was performed.A review of the provided imaging, device history records, instructions for use, manufacturing instructions and quality control data was conducted.A pre-implantation computerized tomographic angiography (cta), implantation angiography, one and 20 months post implantation ctas, 12-month follow up ultrasound, and secondary intervention angiography was provided.Progression of a pre-existing left common iliac artery (cia) stenosis from procedure related injury requiring delayed stenting is confirmed.The stenosis was dissected by the mainbody delivery sheath.After initial improvement, dissection healing worsened the stenosis.Of the other stenoses mentioned, both the right renal artery stenosis and right external iliac artery (eia) stenosis are notable in that hemodynamic significance was suggested before the secondary intervention but no additional investigation was performed during the secondary intervention.Significant findings relative to the patient's anatomy were observed.The left cia stenosis was significantly smaller than the mainbody introducer sheath.The right zbis was implanted in a small stenotic eia.Significant findings relative to the disease state were not observed.Significant findings relative to the use of the device were observed.Left cia stenosis progression was the result of advancing a 7.7f mainbody delivery sheath through a lumen narrowed to 4mmx5.5mm.Significant findings relative to the design or performance of the device were not observed.Cause of adverse events was not observed.Each zenith device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Per the ifu: ¿ vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.¿ pre-existing regions of stenosis/narrowing have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).¿ patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.The ifu also advises to perform appropriate patient follow up so that changes in the structure should they occur, can be identified and addressed before causing clinical problems.The device history record was reviewed and no non-conformances were noted.There is no evidence to suggest that the product was not manufactured to specification.Kink formation in the graft can be due to external compression on the device, inadequate overlap, inappropriate device sizing, tortuous vessels and patient's pre-existing conditions or graft angulation.External compression can be the result of the patient¿s anatomy or another device causing compression of the stent graft, resulting in kink formation.Inadequate overlap can cause a stent graft kink if partial migration occurs but this was not reported.Device planning and sizing from the initial procedure was not provided and therefore cannot be ruled out as a potential contributing factor.However, because the vessel dimensions were smaller than the fixed size of the delivery system resulting in a dissection, it is unlikely that device sizing would have an impact on the event.Tortuous vessels can cause kinking but were not reported in the event or by the image review.Graft angulation was not reported in the event or the image review and is unlikely due to the straight tube design of the zsle.Lastly, the patients pre-existing condition involving stenosis in the same area where the event occurred likely was the cause of the failure.A kink can be caused by a patient¿s pre-existing conditions that would have decreased the lumen diameter and caused stenosis within the graft.Stenosis could also be due to the internal damage of the native artery (can be during the deployment procedure or appropriate ballooning).The image review performed found pre-existing stenosis in the left common iliac artery (cia) prior to the initial procedure.During the initial procedure, a 20f (7.7 mm) main body delivery system was advanced through a stenotic region with a lumen dimensions of 4mm x 5.5mm.The image reviewer stated the stenosis was dissected during this advancement in the initial deployment procedure.This initially improved the stenosis by creating a false lumen due to the tears introduced by the delivery system.Over the next 20 months, the healing process of the dissection caused the stenosis to worsen to a size of 3.6mm x 4.7mm.Per the ifu, do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.The image review also noted mural thrombus within this graft.This potentially occurred due to disrupted flow caused by the stenosis/kinking.This mural thrombus may have also originated for mural thrombus found in the main body graft.These findings provide a likely cause for the stenosis/kinking within the graft to be due to patient anatomy.The events that occurred during the initial procedure assisted or caused the worsening of the stenosis but the patient had pre-existing stenosis in that region.As the dissected stenotic region healed, it likely it compressed the zsle stent graft causing a kink and reduced the lumen size.While some possible causes of kinking cannot be ruled out, they are unlikely given the lack of information, the nature of the patients pre-existing conditions and the nature of the healing process.Measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.

• 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: 7084946
• Report Number: 1820334-2017-04263
• Device Sequence Number: 1298656
• Product Code: MIH
• UDI-Device Identifier: 10827002552460
• UDI-Public: (01)10827002552460(17)170820(10)5205424
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: G55246
• Device Catalogue Number: ZSLE-24-74-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 67