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	G55232
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device information for the other implanted zenith device associated with this endoleak: product identifier: g55239-zsle-16-90-zt.Product lot # (mdr)/product lot #: 9713590.Rpn: zsle-16-90-zt.Expiration date: 05/17/2022.Udi: (b)(4).Manufacture date: 05/17/2019.Reporter occupation: professor.(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 a patient experienced a type 3 endoleak in their left iliac artery following implantation of two zenith flex with spiral-z technology aaa endovascular graft iliac legs.The patient presented with a ruptured left iliac artery aneurysm and an arteriovenous fistula at the "cava / vic", prompting an evar procedure where four grafts were initially implanted.Additionally, a competitor plug device was placed on the left.During the completion angiography at the end of the procedure, a type 3 endoleak appearing to be distal was noticed from the left iliac legs."selective series" suggested that there was adequate overlap between the components.It was also reported that all components were adequately balanced using a cook coda balloon.In response, the grafts were relined using a competitor device.However, the leak persisted from above, prompting a second relining using another competitor device.Following the second relining, the endoleak was gone.Heparin was used during the procedure.The patient was reported to be "okay right now".Apart from relining twice, no other adverse effects have been reported.
Additional Manufacturer Narrative
H6 - method code: device not accessible for testing (4117).Investigation ¿ evaluation.The complaint facility azm informed cook on (b)(6) 2020 of an incident involving zenith flex with spiral-z technology aaa endovascular graft iliac legs (zsle-13-74-zt, lot: 10335514, zsle-16-90-zt, lot: 9713590).A type three endoleak was found in the devices at the conclusion of an evar procedure on (b)(6) 2020.The patient reportedly experienced no adverse effects as a result of this incident, no additional harm was reported.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a visual inspection of imaging was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be performed.However, imaging was provided by the complaint facility.An endoleak was confirmed, and it is believed that the endoleak found in both the first and second angiography post-implantation is either a type iiib or iv, as there is adequate sealing of the zsle leg grafts.It is speculated that the endoleaks could have originated in the same place, however there is not enough evidence to confirm this.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) found that product is safe and effective for its intended use.A review of the device history record (dhr) for lots 10335514 and 9713590 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with these device lots.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field and that the complaint lot was manufactured to current specifications.The instructions for use (ifu), provides the following information related to the reported failure mode: 4.1 general: additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) 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 limb and/or leaks may be required to undergo secondary interventions or surgical procedures.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: endoleak; endoprosthesis: graft material wear; erosion; puncture.11.1 zenith spiral-z aaa iliac leg system: 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.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.Final angiogram.1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12.1 general: all patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Based on the information provided, examination of imaging and the results of our investigation, a definitive root cause for the failure could not be established.Endoleaks are a known inherent risk of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 10451425
• Report Number: 1820334-2020-01559
• Device Sequence Number: 3870982
• Product Code: MIH
• UDI-Device Identifier: 10827002552323
• UDI-Public: (01)10827002552323(17)230225(10)10335514
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 02/25/2023
• Device Model Number: G55232
• Device Catalogue Number: ZSLE-13-74-ZT
• Device Lot Number: 10335514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ PLUG; COOK CODA BALLOON; ENDURANT PAW; ENDURANT PAW; TFFB-24-96-ZT (LOT 9373419); ZSLE-24-74-ZT (LOT 9879879)
• Outcome Attributed to Adverse Event: Required Intervention