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

Model Number	G35395
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: the first knob on the distal component gets loosened.On the second knob, it would not loosen.Had to use hemostats to loosen the second knob.On the number 2 section one is suppose to easily slide it back and then a click is heard.However, this was not the case.The physician had to use all his strength to move it to where it would snap-in.The graft moved up in the sheath a little.The graft was ultimately used and implanted into the sheath.The physician's landing zone was a little lower than what he would have liked.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL 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: 11010604
• Report Number: 3005580113-2020-00459
• Device Sequence Number: 4496304
• Product Code: MIH
• UDI-Device Identifier: 10827002353951
• UDI-Public: (01)10827002353951(17)230203(10)E3946815
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2020
• Report Date (Section F): 12/10/2020

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: 02/03/2023
• Device Model Number: G35395
• Device Catalogue Number: ZTA-D-38-147-W
• Device Lot Number: E3946815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• 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