MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47467
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: physician modified graft and created 4 fenestrations for the syliac sma left and right renal.They deployed the graft and were able to get out the fenestrations and were able to place stents out the fenestrations.But they had a small disection in the silliac which they were able to stent and fix.Then another disection in the sma (superior mesenteric artery) which they were not able to fix right away and had to go in and do a bypass on.Patient outcome: the event did require an additional procedure due to this occurrence: bypass the patient did not report any adverse effects due to this occurrence.The patient was hospitalized or was there prolonged hospitalization due this occurrence: there probably will be a longer than expected hospital stay.

• Brand Name: ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 14712212
• Report Number: 3005580113-2022-00067
• Device Sequence Number: 12030901
• Product Code: MIH
• UDI-Device Identifier: 10827002474670
• UDI-Public: (01)10827002474670(17)250328(10)E4239187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/16/2022
• Report Date (Section F): 06/16/2022

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
• Device Expiration Date: 03/28/2025
• Device Model Number: G47467
• Device Catalogue Number: ZDEG-PT-32-202-PF-US
• Device Lot Number: E4239187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2022
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/16/2022