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	G55242
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hematoma (1884); No Code Available (3191)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: molding balloon (g03831, lot 5257294).(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
On (b)(6) 2014 under general anesthesia, the patient underwent placement of a three-piece aaa endovascular graft.A 32 mm x 108 mm main body component, a 24 mm x 90 mm ipsilateral right iliac leg graft, and a 20 mm x 74 mm contralateral left iliac leg graft (subject of this report) were deployed.The proximal edge of the graft material was deployed proximal to the renal arteries.A molding balloon was used during the procedure without difficulty or complications.No ancillary components were used and no additional procedures were performed.The completion angiogram demonstrated that the endovascular graft was patent with no evidence of a kink or an endoleak.Core lab analysis of the completion angiogram noted a patent graft with no evidence of a kink or endoleaks.The patient¿s estimated blood loss was 120 cc and no blood products were given intra-operatively.No patient-related adverse events were observed during the procedure.On (b)(6) 2014 the patient was discharged taking antiplatelet medication.On (b)(6) 2018 the patient had a routine follow-up ct scan that revealed a kink in the left iliac leg graft.On x-ray dated the same day the site also reported kink.Upon retrospective review the site reports kink present on (b)(6) 2017 x-ray with kink unchanged from that initial finding.Core lab has not reported kink on any imaging submitted for this patient.On (b)(6) 2018 the patient had a secondary intervention (percutaneous angioplasty and stent placement) to treat left iliac leg graft kink where it was reported to have been successful.On (b)(6) 2018 the patient was diagnosed with a hematoma reported to have observed at the procedural site requiring receipt of blood products.The patient required an overnight stay in the hospital and two units of packed red blood cells.He reportedly recovered from this.No further issues have been reported.The patient was reported to be taking an anti-platelet but not an anticoagulant at this last clinical follow-up.The type of anti-platelet medication is unknown.
Event or Problem Description
No new event information has been received.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation/evaluation.The device was not available for evaluation as it remains implanted in the patient.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 study, procedure angiography, postoperative computerized tomography (ct) scan studies at 5 week, 6 month, 12 month, 25 month and 40 month intervals, and postoperative x-ray films at 5 week, 6 month, 25 month and 40 month intervals (11 total studies) were provided for review.The angiography procedure dated 12/8/14 was reviewed.Initial angiogram shows aneurysmal dilation of the infrarenal aorta.There appears to be an embolization coil in the area of the inferior mesenteric artery (ima).The main body graft (zalb 32 x 108 mm) is advanced from the right side and partially deployed with the contralateral limb oriented to the left.The left iliac leg (zsle 20 x 74 mm) is deployed with adequate overlap in the contralateral limb, followed by release of the ipsilateral limb.The right iliac leg (zsle 24 x 90 mm) is placed from the ipsilateral limb to the distal right common iliac artery (cia).Completion angiography shows a patent endograft with the proximal graft positioned just below the renal arteries.The 12 month ct study, dated 12/17/15, was reviewed.There is an increase in the angulation of the left zsle leg at the distal contralateral limb junction, now measuring 72.5 degrees.Again, the lumen at the angulation appears patent.The focal narrowing of the zsle leg just proximal to this angulation, in the mid segment of the limb, persists with a minimum diameter of 5.2 mm.The 25 month postoperative ct study, dated 1/5/17, was reviewed.The focal narrowing of the proximal left zsle leg persists with a lumen diameter reduced to 4.5 x 5.7 mm.There is increased angulation of the left iliac leg at the distal limb junction, now measuring 77 degrees.The 25 month postoperative x-ray films show increased angulation of the left zsle iliac leg at the level of the distal contralateral limb, creating a bend just distal to the first sealing stent.The 40 month postoperative ct study, dated 4/12/18, was reviewed.The left iliac leg angulation at the distal limb junction has again increased, now measuring 87 degrees.The graft lumen at this bend appears patent.The focal lumen narrowing of the left zsle leg proximal to this angulation is still seen.The zsle lumen diameter narrows from 10.5 mm at the proximal leg edge to 4.4 x 5.6 mm at the mid limb segment.The 40 month postoperative x-ray films appear similar to the previous study with severe angulation of the left iliac zsle leg just distal to the first sealing stent segment.Significant findings of the image reviewer: 1.) an infrarenal abdominal aortic aneurysm (aaa) is successfully repaired with a zenith alpha 32 x 108 mm main body graft, a zsle 24 x 90 mm iliac leg on the right and a zsle 20 x 74 mm iliac leg on the left.2.) the report says a molding balloon was used during the procedure, though no images are provided showing this.3.) at 5 week follow-up, there appears to be a focal hourglass narrowing of the proximal left zsle iliac leg in the overlap segment with the contralateral limb.This is located at the mid limb level and does not appear to involve the limb itself.The zsle leg lumen narrows from 10.5 mm at the proximal leg edge to a minimum diameter of 5.3 mm at the mid limb and then immediately re-expands to 9 mm.This focal narrowing could be a kink in the leg graft, though the leg appears straight without any bend or angulation at 5 weeks.There is no obvious source of extrinsic compression here.The cause of this focal narrowing cannot be determined from the imaging provided.This finding persists throughout the follow-up period to 40 months.4.) there is progressively increased angulation of the left zsle iliac leg throughout the follow-up period.The preoperative imaging shows a straight left cia without tortuosity.The left zsle iliac leg appears to be straight at the time of repair and on the immediate postoperative imaging at 5 weeks.Angulation of the leg at the distal contralateral limb junction appears at 6 months and progressively increases from 52 degrees to a severe 87 degree bend at 40 months.This corresponds with an increase in total length from the lra to the left iliac bifurcation from 176 mm at 5 week to 190 mm at 40 months, along with regression of the aaa sac.This progressively worsening angulation is due to elongation and aortoiliac remodeling over the 40 month interval.Of note, the focal lumen narrowing of the left zsle iliac leg in the contralateral limb is unrelated to this angulation and bending of the leg.This narrowing is seen immediately postoperatively prior to any evidence of angulation.Also, this focal narrowing or kink is located just proximal to the area of angulation throughout the follow-up imaging.5.) mural thrombus within the main body graft is first seen at 6 months and persists at 40 months.A thin layer of thrombus is seen along the anterior wall of the main body graft lumen at 6 months, but this area of thrombus decreases at 12 months and appears resolved at 25 months.At 25 months, however, there is significant thrombus along the posterior wall of the graft, beginning at the level of the suprarenal stent (in the native aorta) and extending to the level above the flow divider.At 40 months, thrombus occupies 30-40% of the main body graft lumen at the mid segment.The thrombus does not extend into the renal arteries, proximally, or into the iliac legs, distally.On preoperative imaging, the proximal aortic neck displays significant reverse tapered anatomy with the diameter narrowing from 29 mm at the lra to 24.3 mm at the 15 mm seal zone.This 16% diameter change is outside of ifu for the zenith device, and the 32 mm graft is significantly oversized for the distal neck diameter of 24.3 mm.Though the cause of thrombus appearing within the main body graft cannot be definitively determined from the imaging provided, this thrombus formation could be related to graft oversizing in this incompatible aortic neck anatomy.The image reviewer confirmed the kink on the left zsle-20-74.There is no indication that the device was manufactured out of specifications.There was focal narrowing of the proximal left zsle in the overlap segment with the contralateral limb first observed on the 5 week follow-up imaging and persisted throughout the follow-up period to 40 months.The image reviewer stated that the narrowing could be a kink in the leg graft, though the leg appears straight without any bend or angulation at 5 weeks.There was also no obvious source of extrinsic compression.The cause for the proximal zsle focal narrowing cannot be determined from the imaging provided.There was also angulation of the zsle leg observed at the distal contralateral limb junction.52 degree angulation was first observed at 6 months and progressively increased to 87 degrees at 40 months.The image reviewer attributed the progressively worsening angulation to elongation and aortoiliac remodeling over the 40 month interval.The narrowing of the zsle graft was observed proximal to the area of angulation.The image reviewer concluded that the narrowing of the zsle graft was unrelated to the angulation observed.Thrombus formation was confirmed in the zalb-32-108-ci (lot: 5079335).This device is not sold in the us and there is not a similar device manufactured by cook inc that is marketed in the us.A review of the device history record (dhr) for the final assembly and graft subassembly revealed no non-conformances documented for either of the lots reviewed.The instructions for use (ifu) states the following in consideration of the reported failure mode: indications for use: ¿ the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, zenith universal distal body endovascular graft, zenith flex aui, or zenith branch iliac endovascular graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.Warnings and precautions: ¿ patients experiencing educed blood flow through the graft limb and/ or leaks may be required to undergo secondary interventions or surgical procedures.¿ pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliac's) 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.Dilation 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.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary (e.G., adjunctive ballooning or stenting).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.¿ follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patient with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Directions for use: ¿ section 11.1.5: ipsilateral iliac leg placement and deployment - 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.Potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: ¿ arterial or venous thrombosis and/or pseudoaneurysm ¿ claudication (e.G., buttock, lower limb) ¿ graft or native vessel occlusion focal narrowing and progressively increasing angulation of the left zsle-20-74-zt iliac leg graft was confirmed from review of the imaging provided.The image reviewer observed focal hourglass narrowing of the proximal left zsle within the contralateral limb on the 5 week follow-up ct.The zsle graft lumen narrowed from 10.5 mm at the proximal leg edge to a minimum diameter of 5.3 mm at the mid limb and then immediately re-expanded to 9 mm.This appeared to be unrelated to the progressively increasing angulation because the focal zsle narrowing was observed 5-weeks after implantation, before any angulation was observed.Additionally, the image reviewer could not identify an obvious source of extrinsic compression that would contribute to the narrowing.Although not seen on the imaging provided, the customer facility reported that a molding balloon (coda-2-9.0-35-120-32, lot 5257294) was used during the procedure without difficulty or complications.There was also angulation of the zsle leg observed at the distal contralateral limb junction.52 degree angulation was first observed at 6 months and progressively increased to 87 degrees at 40 months.The image reviewer attributed the progressively worsening angulation to elongation and aortoiliac remodeling over the 40 month interval.The angulation observed exacerbated the focal zsle narrowing within the zalb contralateral limb.The minimum lumen diameter of the zsle graft was narrowed to 4.53mm at 25-months and 4.37mm at 40-months post implantation.The ifu provided with the device warns, follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patient with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.This complaint is confirmed based on imaging provided.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specifications.A definitive cause for the left zsle-20-74-zt focal narrowing within the contralateral limb could not be established in this investigation.Possible contributing factors are related to device deployment and molding balloon use.The zsle graft was further narrowed to less than 5mm in the presence of progressively increasing angulation to 87 degrees over the post-operative time interval.The image reviewer attributed the angulation to elongation and aortoiliac remodeling.Therefore, the investigation conclusion for the reported device kink resulting in the need for additional graft placement is related to disease progression and patient anatomical changes.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.Cook will continue to monitor for similar complaints.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.

• 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: 8090060
• Report Number: 1820334-2018-03087
• Device Sequence Number: 11082506
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)171015(10)5345013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 10/15/2017
• Device Model Number: G55242
• Device Catalogue Number: ZSLE-20-74-ZT
• Device Lot Number: 5345013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 05/20/2019
• 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: 37 YR
• Patient Weight: 171