MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35375
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: there is a moderate amount of luminal thrombus within the alpha graft ((b)(4)).Per (b)(4) manufacturer report# 3002808486-2021-01880: "component separation.Near zero overlap.Component separation, latest imaging available." on (b)(6) 2017: resection of ischemic portion of sigmoid colon without anastomosis.Sma thrombectomy, left iliac to common hepatic and superior mesenteric artery (sma) bypass with 14x7 bifurcated hemashield gold graft, left sigmoid colectomy and cholecystectomy.On (b)(6) 2017: exploratory lap, left hemicolectomy, open abdomen.On (b)(6) 2017: exploratory laparotomy, removal of five 12 x 12 surgical pads and placement of 5 new 16 x 16 surgical packs, 2 in the splenic bed, 2 immediately anterior to the pancreas in the retroperitoneum, and 1 within the gallbladder fossa.Patient outcome: patient expired on (b)(6) 2017.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• 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: 13251001
• Report Number: 3005580113-2022-00010
• Device Sequence Number: 4431833
• Product Code: MIH
• UDI-Device Identifier: 10827002353753
• UDI-Public: (01)10827002353753(17)190411(10)E3436335
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2022
• Report Date (Section F): 01/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2019
• Device Model Number: G35375
• Device Catalogue Number: ZTA-P-46-179-W
• Device Lot Number: E3436335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2022
• Date Device Manufactured: 04/11/2016
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/13/2022