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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 the clinical study patient enrolled in the study to treat juxtarenal aaa.In 2018, the patient underwent a secondary intervention for a type 1b endoleak.The pre-procedure ct scan showed a maximum aneurysm diameter of 51 mm.The proximal neck was irregular in shape, with mild thrombus and calcification.There was mild tortuosity of the iliac arteries bilaterally.The right iliac artery showed mild calcification in the common iliac artery and no calcification in the external iliac artery.There was no occlusive disease in any portion of the right iliac artery.The left iliac artery showed no calcification in any portion of the artery, mild occlusive disease in the common iliac artery, and no occlusive disease in the external iliac artery.The angle between the immediate suprarenal neck and immediate infrarenal neck was 31 degrees.The angle between the proximal neck and the longitudinal axis of the aneurysm was 32 degrees.There was no renal infarct or renal ischemia bilaterally.Core lab analysis of the pre-procedure ct scan noted the following: the maximum aneurysm diameter was 51.5 mm.The proximal neck was parallel in shape, with mild thrombus and calcification.There was mild tortuosity of the iliac arteries bilaterally.The right iliac artery showed mild calcification and occlusive disease in the common iliac artery and no calcification or occlusive disease in the external iliac artery.The left common and external iliac artery showed mild calcification and occlusive disease.The angle between the immediate suprarenal neck and immediate infrarenal neck was 14 degrees.The angle between the proximal neck and the longitudinal axis of the aneurysm was 32 degrees.There was mild occlusive disease of the renal arteries bilaterally with no evidence of renal infarct bilaterally.A right accessory renal artery was noted distal to the main right renal artery.On (b)(6) 2015, the patient received a zfen-p-2-32-124-r proximal component (lot number ac949098), a zfen-d-20-62-91-c distal component (lot number ac949099), and a zsle-24-74-zt spiral z iliac leg (lot # 4453945).A molding balloon was used.One 6 mm x 22 mm atrium icast stent was placed in the right renal artery and was flared.One 7 mm x 22 mm atrium icast stent was placed in the left renal artery and was flared.Iliac angioplasty was performed after device deployment.At the conclusion of the case, the endovascular graft and both fenestrated and stented renal arteries were patent with no kinks or endoleaks.Core lab review of the procedural angiogram noted patency of the endovascular graft and stented renal arteries.Patency of the right accessory renal artery could not be verified.During the procedure, the right common femoral sheath slipped out into the femoral artery and the patient developed a hematoma in the extraperitoneal area.The patient¿s estimated blood loss was 2500 cc and the patient received 675 cc of cell saver blood intra-operatively.An additional two units of prbcs were given post-operatively.On (b)(6) 2015 (two days post-procedure), the patient was discharged from the hospital.Core lab review of scheduled follow-up imaging (a ct dated (b)(6) 2018) noted ¿left iliac growth at distal aspect & left iliac type 1b leak¿.On (b)(6) 2018 (1316 days post-procedure), the subject underwent intervention for, left common iliac aneurysm status post fenestrated aortic endograft with loss of wall apposition of the left iliac limb (type 1b endoleak).Treatment included an aortogram with left iliac arteriogram, coiling of the left hypogastric artery, percutaneous placement of a gore iliac extender limb into the left external iliac artery.The patient was asymptomatic, recovered from treatment and remains in the study.
Additional Manufacturer Narrative
Investigation evaluation: the device was not available for evaluation.Without the complaint device, a physical investigation was not able to be completed.Imaging was provided for review.A document based investigation has been performed including a review of the provided imaging, device history record, instructions for use, and quality control data.A preoperative ct scan, procedure angiography, postoperative ct scans at 2 weeks, 4 months, 12 months and 37 months, postoperative x-ray films at 12 months and 24 months, and postoperative ultrasound studies at 24 months and 37 months (10 total studies) were provided for review.The 2-week postoperative ct study, dated (b)(6) 2015, was reviewed - no endoleak is seen and the iliac leg seals circumferentially in the proximal right cia.The 4-month postoperative ct study, dated (b)(6) 2015, was reviewed - no endoleak is seen.The 12-month postoperative ct study, dated (b)(6) 2016, was reviewed - no endoleak is seen.The 37-month postoperative ct study, dated (b)(6) 2018, was reviewed - there is a large type 1b endoleak around the limb.Per observation of the image reviewer: at 37 months, there is complete loss of graft wall apposition of the left ipsilateral limb in the mid to distal left common iliac artery (cia) with a large type 1b endoleak.This is due to continued dilation of the left cia from 23 mm preoperatively to 32 mm at 37 months.The continued dilation is due to placement of an undersized limb and lack of circumferential graft wall apposition in the distal left cia, evident immediately following repair.Per findings of the image review: the preoperative ct study, dated (b)(6) 2014, is reviewed.There is a dumbbell-shape juxtarenal aaa with a maximum diameter of 52.1 x 50 mm.The infrarenal neck length is 6 mm.Proximal aortic diameter is 29.5 x 26.9 mm above the superior mesenteric artery (sma), 29 x 28 mm just below the sma, 28.7 x 23.2 mm at the lra, and 26 x 22 mm at the distal neck.The celiac, sma, and bilateral renal arteries are patent.The pararenal neck has a 25-degree angulation relative to the supraceliac aorta.The infrarenal neck has a 16-degree angulation relative to the pararenal neck.The functional pararenal neck has a 34-degree angulation relative to the long axis of the aneurysm.The right cia has mild tortuosity and mild calcification and dilates to a maximum diameter of 22.3 x 20.5 mm in the mid to distal segment (presumed distal seal zone).The distal cia diameter just above the bifurcation measures 16 x 15 mm.The left cia has little to no calcification and only mild tortuosity.The left cia dilates to a maximum diameter of 23 x 20.3 mm in the distal seal zone.Just above the bifurcation, the left cia measures 14.3 x 14.8 mm.The 2 week postoperative ct study, dated (b)(6) 2015 , is reviewed.The proximal graft begins distal to the celiac trunk.The sma is patent via a fenestration in the graft.There is a 29 mm length of proximal seal with 15 mm of seal below the sma fenestration.Bilateral renal stents are patent.No endoleak is seen.The maximum aaa diameter is 53.2 x 50.1 mm.The distal body overlaps in the proximal zfen graft by 77 mm with the ipsilateral limb landing in the distal left cia.The distal limb (20 mm diameter) lacks circumferential wall apposition in the distal left cia seal zone where the artery diameter measures 26.2 x 24.8 mm.However, no endoleak is seen here and the limb seals through the rest of the left cia proximal to this.The right iliac leg (zsle 24 x 74 mm) overlaps in the contralateral limb by 24 mm and lands in the distal right cia.The distal leg lacks circumferential wall apposition in the distal cia seal zone where there is some calcification in the artery wall.However, no endoleak is seen and the iliac leg seals circumferentially in the proximal right cia.The 37 month postoperative ct study, dated (b)(6) 2018, is reviewed.The proximal zfen graft diameter is 30 x 28 mm.The proximal position is unchanged and the sma and bilateral renal stents remain patent.The aaa sac is completely collapsed around the endograft with a maximum aortic diameter of 32 mm and no evidence of endoleak.The ipsilateral limb is fully expanded to 20 mm, distally, and lands in the mid left cia.The left cia is now dilated to 32 mm diameter at this level and the limb has no wall apposition in the mid to distal artery.There is a large type 1b endoleak around the limb.The limb seals for a length of 10 mm in the proximal left cia, however, so the endoleak does not extend into the aorta.The right iliac leg seals throughout the right cia with a distal graft diameter of 22 mm.There is no distal endoleak on the right.Per analysis of the results of the image review, the type 1b endoleak in the left ipsilateral limb is confirmed with the left common iliac artery (cia) being dilated now to 32mm with the ipsilateral limb fully expanded to 20mm, distally, and landing in the mid left cia.This left limb has no wall apposition in the mid to distal artery and is most likely as a result of a combination of disease progression/human anatomy and sizing selection (undersizing).The instructions for use (ifu) 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.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.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.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.A review of the device history records revealed there were no non-conformances detected.It has been concluded that the complaint is confirmed based on the image review, and that a combination of human anatomy/disease progression and sizing selection (undersizing) contributed to this incident.It was observed in the image review in the pre-op, the physician had sized the iliac leg diameter (24mm) for the intended iliac vessel diameter (23 x 20.3 mm) which falls outside of the recommended maximum diameter for the iliac vessel for a 24mm iliac leg in the ifu.The ifu states in table 10.5.1 spiral-z aaa iliac leg graft sizing guide that the intended iliac vessel diameter for an iliac leg diameter of 24mm is 19-20mm.This was seen as more evident 2 weeks post-op, that there was a lack of wall apposition distal limb in distal left cia seal zone (no endoleak).Disease progression/human anatomy also played a contributing role as 37 months post-op imaging revealed the complete loss of wall apposition from the mid to distal artery as a result of the vessel dilating from the original pre-op diameter of (23 x20.3mm) to 32mm at this stage.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.However, the monitoring of trends for similar complaints will continue, and the appropriate personnel have been notified of this event.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.
Event or Problem Description
There has been no new event information received.

• 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: 8034911
• Report Number: 1820334-2018-03084
• Device Sequence Number: 11144479
• Product Code: MIH
• UDI-Device Identifier: 10827002552460
• UDI-Public: (01)10827002552460(17)160801(10)4453945
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 08/01/2016
• Device Model Number: G55246
• Device Catalogue Number: ZSLE-24-74-ZT
• Device Lot Number: 4453945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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: 70 YR