MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55363
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/16/2019
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 initially reported on (b)(6) 2019, "hole in the graft".The zenith renu aaa ancillary graft converter was implanted on (b)(6) 2019 to repair an existing type ib endoleak in previously implanted bilateral medtronic limbs.Heparin was given at the start of the procedure.Access was gained via the right femoral us guided percutaneous access, using a proglide preclosure and a 9 fr sheath.Right iia cannulated and branches and ectatic iia coil embolized.A zenith renu aaa ancillary graft converter was deployed across right limb extension to eia.Balloon moulding to the zenith renu aaa ancillary graft converter and limb.Angiogram showed brisk endoleak, persistent despite repeat prolonged moulding.Further angiography in several angulations and with coda balloon inflated demonstrated a defect in the zenith renu aaa ancillary graft converter fabric.An additional stent graft was deployed within distal zenith renu aaa ancillary graft converter, and then an additional zenith renu aaa ancillary graft converter was deployed one stent length above the first, and again balloon moulded.Final angiography showed no leak and patent eia.Proglide closure.Successful repair of type ib endoleak on the previously implanted grafts from another manufacturer and intra-procedural type iiib endoleak.Calcification was present in the iliacs but the zenith renu aaa ancillary graft converter was placed through the existing limbs so the physician felt this would not be a factor.Additionally there was no tortuosity in the patient's vessels.The patient is doing well and has no additional adverse effects due to this event.
Event or Problem Description
There is no new event information to report.
Additional Manufacturer Narrative
D11-concomitant products: coda 32mm balloon, lunderquist wire.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 provided imaging, the device history record, instructions for use, and quality control data.A review of the device history records (dhr) revealed no non-conformances were detected.Cook was unable to perform a physical evaluation of the complaint device as the product was not returned; the device remains implanted in the patient.Each zenith renu aaa ancillary graft converter device is shipped with instructions for use (ifu).This document includes instructions for use, contraindications, warnings and precautions regarding use of this device.Warnings and precautions the zenith renu aaa ancillary graft is not intended for primary endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms.It is intended for use in patients in whom an endovascular graft has already been placed.Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable fixation length (both the vessel and component overlaps) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft and/or leaks may be required to undergo secondary interventions or surgical procedures.Patients with specific clinical findings (e.G.Endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Irregular calcification and /or plaque may compromise the attachment and sealing at the fixation sites.Section 4.4 ¿ device selection.Strict adherence to the zenith renu aaa ancillary graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).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.Potential adverse events: aneurysm enlargement.Endoleak.Image reviewer findings: right iliac angiogram reveals a type 1b endoleak around the distal right limb.The right hypogastric artery is cannulated and packed with multiple coils.A zenith renu converter graft (ax1-2-24-113) is placed from the mid right limb to the distal right cia with an iliac leg extension appearing to land in the proximal right eia past the level of the coils.Repeat angiogram shows a large endoleak within the right excluder limb around the renu converter graft, filling the right cia.This is either a proximal junctional leak around the renu graft with contrast filling into the right limb, or a type 3b defect in the renu graft somewhere in the segment within the right excluder limb.A coda balloon is inflated across the proximal to mid renu graft and contrast injection shows no endoleak.Another angiography run shows contrast filling the proximal to mid segment of the renu graft but not above the proximal edge of the renu graft.The endoleak is still evident, so it is likely a graft defect rather than a junctional leak around the proximal graft edge.A second renu graft (ax1-2-26-113) is placed more proximally, beginning at the level of the proximal main body excluder graft, re-lining the first renu graft.Final angiography shows patent flow down the right side with no endoleak evident.Contrast does not fill the distal extension leg on the right, likely due to the sheath obturating the distal leg lumen.The left leg is patent with faint contrast filling.Impressions of the imaging reviewer: a previously implanted gore excluder endograft has a type 1b endoleak around the distal ipsilateral (right) limb in the right cia.An attempt to treat this with endoluminal repair is made by coil embolization of the right hypogastric artery and placement of a zenith renu converter graft and iliac leg extension from the proximal ipsilateral limb to the proximal right eia.Immediately following implantation, there is a large endoleak around the renu converter graft filling the ipsilateral limb and right cia.The endoleak is still evident even when contrast does not go above the proximal edge of the renu graft (ruling out a proximal junctional leak), and it does not appear when a coda balloon is inflated across the proximal to mid renu graft.This is most likely a type 3b graft defect somewhere in the proximal to mid renu converter graft.The endoleak is successfully treated with placement of a second renu converter graft positioned more proximally and re-lining the original converter graft.The cause of the graft defect cannot be determined from the imaging provided.There was calcification as well as another manufacturer¿s limb graft present when the device was placed.It is feasible to suggest resistance could have occurred during placement.Based on the image review the complaint is confirmed as there is a type 3b endoleak within the first ax1 device placed.This complaint is confirmed based on image review.Based on the images provided the hole in the material is most likely a type 3b endoleak.The image review stated that immediately following implantation, there is a large endoleak around the renu converter graft filling the ipsilateral limb and right cia.The endoleak is still evident even when contrast does not go above the proximal edge of the renu graft (ruling out a proximal junctional leak), and it does not appear when a coda balloon is inflated across the proximal to mid renu graft.This is most likely a type 3b graft defect somewhere in the proximal to mid renu converter graft.The endoleak is successfully treated with placement of a second renu converter graft positioned more proximally and re-lining the original converter graft.The cause of the graft defect cannot be determined from the imaging provided.Based on the investigation and image review there is no indication that the device was made out of specification.A definitive conclusion could not be determined.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.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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 RENU AAA ANCILLARY GRAFT CONVERTER
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8294153
• Report Number: 1820334-2019-00255
• Device Sequence Number: 19207539
• Product Code: MIH
• UDI-Device Identifier: 10827002553634
• UDI-Public: (01)10827002553634(17)201212(10)8395022
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 12/12/2020
• Device Model Number: G55363
• Device Catalogue Number: AX1-2-24-113-ZT
• Device Lot Number: 8395022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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: 87 YR