MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G31453
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent an evar procedure as part of the 17-07 zenith fenestrated+ endovascular graft clinical study.On (b)(6) 2025 (180 days post-procedure), the 6m follow-up ct imaging was completed.Per site review, the endograft devices and visceral vessels within stent and native vessel were patent.There was no stenosis >50% in any treated vessel.There was no endoleak, separation of components, no evidence of migration, evidence of device integrity issue, or evidence of thrombus within a study device.Per core lab review, the endograft devices were patent, there was no stenosis of the bilateral iliac leg grafts or visceral vessels.There was no endoleak, no separation of components, no evidence of migration, and no evidence of device integrity issues.There was evidence of thrombus within unibody2 which was an initial finding.On the same day, the patient was diagnosed with an arterial dissection of the right external iliac artery.The event is ongoing and will be treated on (b)(6) 2026 with a stent placement.The site considered the event probably related to the right zsle iliac leg graft, noting ¿arterial injury due to passage of device with gradual occlusion.¿ the site considered the event probably related to the study procedure, noting, ¿passage of wire/catheter/sheath causing damage to the external iliac.¿ the event was considered possibly related to a cook ancillary device, marked as dilator/dilator set, introducer/sets, and wire guide.There were 3 dilator/dilator sets entered in the crf and site was queried to confirm if the relatedness was concerning one set or all three [complaint not opened by cri until device(s) confirmed].There were no introducer/sets entered in the crf and site was queried to review/confirm.The site considered the patient¿s history of pad and calcific disease to be a contributing factor to the event.The pi provided the following comment, "prior to index procedure, this patient already had moderate to severe calcific disease of his right external iliac artery.While no large dissection was noted in the first post-op scan, upon review of all post op scans this area's disease progressed rapidly, from an index 50% stenosis, to 60%, to finally 90% which led to treatment.I associate this with both progression of his natural disease, however expedited by microvascular intimal injury due to our index intervention.-pi." patient outcome: the event is ongoing and was reported to be treated on (b)(6) 2026 with a stent placement.The patient remains in the study.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• MDR Report Key: 24234320
• Report Number: 3005580113-2026-00009
• Device Sequence Number: 21379253
• Product Code: MIH
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)300307(10)E4675122
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2026
• Report Date (Section F): 02/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: G31453
• Device Catalogue Number: TSMG-35-260-LES
• Device Lot Number: E4675122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 02/02/2026