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

Model Number	G35519
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): p140016 investigation is still in progress.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: deployed the device with no problem.When removing the delivery system form the sheath, the patient started bleeding.It stopped when the sheath valve was turned to a closed position, but abnormal amount of bleeding through valve when open.Patient outcome: the blood loss was approximal 50ml.The patient did not require any treatment or blood transfusion for the blood loss.
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).The customer reported the bleeding from sheath, when the captor hemostatic valve was in an open position.However, the bleeding stopped when the valve was turned to a closed position.Per the device evaluation, close and open function of the captor hemostatic valve worked as intended, and the silicone discs inside the valve were closing completely, indicating that the device has performed as intended.Therefore, this complaint does not constitute a valid complaint and the event is thereby not reportable as no device deficiency was detected.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56856868382
• MDR Report Key: 21166068
• Report Number: 3002808486-2025-00009
• Device Sequence Number: 9475206
• Product Code: MIH
• UDI-Device Identifier: 10827002355191
• UDI-Public: (01)10827002355191(17)250503(10)E4252432
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2025
• Device Model Number: G35519
• Device Catalogue Number: ZTA-DE-34-112-W
• Device Lot Number: E4252432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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
• Patient Sex: Unknown