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 Codes	Complete Blockage (1094); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ischemia (1942); Thrombus (2101); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: aaa-body-inverted-leg, lot number ac1010476, zsle-16-90-zt, lot number 7791434.Customer information: phone: (b)(6).(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the patient experienced critical ischemia of the right lower limb due to an occlusion of the right zenith flex with spiral-z technology aaa endovascular graft iliac leg.The product used was a custom made bifurcated infrarenal graft with an inverted limb on the contralateral side.On (b)(6) 2019, a femoral embolectomy of the right branch was performed unsuccessfully.It was noted that an anesthetist opposed an endovascular aortic repair as compared to an open surgery approach prior to the procedure.A decision was made on (b)(6) 2019 to perform a femorofemoral bypass.Since, the physician has noted that the femorofemoral bypass has not shown successful results as the patients right foot has not responded as expected.Another surgery was performed on (b)(6) 2019.Additional information was requested regarding the patient's current status as well as the type of procedure planned for (b)(6) 2019.A response from the customer has not been received at the time of this report.
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
The translated radiology report was provided on (b)(6) 2019 and revealed there was suspected ischemia of the lower right limb of the previously implanted aorto-iliac prosthesis.The examination was carried out after arterial opacification.In the abdomen, there is a sub-renal abdominal aneurysm, 55 mm in diameter, with no signs of rupture.At the stent, there is a partial thrombosis extending to the start of the right iliac prosthesis, which is totally thrombosed.External femoral artery revascularization was achieved through collateral circulation.Insufficient vascularization was noted at the popliteal fossa.There was sufficient opacification to the left of the iliac prosthesis and the left external iliac artery is opacified up to the popliteal fossa.On (b)(6) 2019, the physician checked if the fem-fem bypass done on (b)(6) 2019 with the aesculap/bbraun graft was not occluded because nurses reported patient¿s right feet did not seem healthy.Nothing was occluded on this date.It was clarified that the statement, "counter-anesthesist indication to deposit both endoprotheses by abdominal." means the physician was initially thinking about performing an open procedure to explant the cook grafts implanted in 2012 and 2018, but this idea was rejected by the anesthetists because of patient¿s condition (as an 84 year old man, it was believed he was too old).
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional information and correction: h6 additional patient code: ischemia (1942).Additional method code: device not returned (4114).Correction to device code: complete blockage (1094).Investigation/evaluation: a review of documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control, and a visual inspection of imaging provided of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a post-implantation cta was provided and sent for expert image review.The imaging date was not provided; however it was concluded that it was not performed recently after implantation as normal acute post-operative groin changes had resolved.It was concluded that thrombus was able to be seen on both implanted devices.Stenosis was present entering the right common iliac artery.There is no evidence to suggest that the product was not manufactured to specification.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify potential non-conformances prior to distribution.A review of the dhrs for the complaint lot: (8125683) and related sub-assembly lots found no recorded non-conformances.As this is a one-device lot, there are no other potentially non-conforming products in distribution.A database search revealed this to be the only event associated with the provided compliant lot.As there are no related non-conformances, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product instructions for use (ifu) (t_zaaasz_rev4) states the following in consideration of the reported failure mode: ¿4.2 patient selection, treatment and follow-up: zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.4.2 patient selection, treatment and follow-up: zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.Adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 14 french to 17 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.Pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Dilatation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event all patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.Patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event all patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.The zenith spiral-z aaa iliac leg has not been explicitly evaluated clinically; however, its performance is represented by the zenith aaa endovascular graft iliac leg (a previous version of the device), which has not been evaluated in the following patient.Populations: key anatomical elements that fall outside the sizing requirements specified in the appropriate main body or renu instructions for use successful patient selection requires specific imaging and accurate measurements; please see section.4.3 pre-procedure measurement techniques and imaging diameters utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.4.4 device selection: strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size (table 10.5.1).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.4.5 implant procedure inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Inadequate fixation of the zenith flex aaa endovascular graft may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endorposthesis may require surgical intervention.11.1.7 molding balloon insertion 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.(fig.15).6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.(fig.15).10.Remove molding balloon and replace it with an angiographic catheter to perform completion angiograms." based on the information provided, no product returned, and the results of our investigation, it was concluded that the cause cannot be traced to the device but rather to patient condition (i.E.Right iia and eia moderate to severe stenosis).Per the expert image review, the lumen diameter entering the right cia was reduced to 8 mm.This area of stenosis would significantly limit outflow resulting in there to be a higher propensity for mural thrombus formation, particularly downstream and surrounding regions.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been taken to address this failure mode.It was determined that no further action is required at this time.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8894779
• Report Number: 1820334-2019-02014
• Device Sequence Number: 16520057
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)200821(10)8125683
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 8125683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 12/19/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 08/30/2019; 01/02/2020
• 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: 84 YR