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

Model Number	G47493
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p180001 investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: while trying to remove the trigger wires, they could not be removed - and for this reason the device twisted.The wires were eventually removed after some manipulation.The graft was delivered and implanted successfully." (b)(4).Additional information received on 31jan2022: the top cap has not been retrieved.(b)(4).Devices used or implanted during the procedure: zta-p-36-209-zt, lot# e4144964, coda-2-9.0-35-120-32, and argon medical devices atrieve vascular snare kit.Petticoat was advanced from femoral access to the desired location in the thoracic aorta.Once three stents of overlap was achieved, the anti-torque was released.The device was them unsheathed to the distal end.The physician attempted to release trigger wires via unscrewing the white thumb screw and pulling back on the green trigger wire handle but was unsuccessful.After multiple attempts of trying to remove the green wire handle, the physician unscrewed the white cap to expose the inner cannula and trigger wire lumen.He was then able to pull back on the trigger wires directly with snaps.Patient outcome:.Part of the delivery system remain inside the patient's body.The grey positioners' top cap remains inside the patient.After the initial procedure, the patient recovered that week.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).This complaint will be closed as it is assessed that the failure mode in this complaint will be handled in the related complaint (b)(4) (manufacturer report # 3005580113-2022-00009), as it is a cascade of events from (b)(4).Event is therefore no longer reportable to fda and all further information will be handled in (b)(4) (manufacturer report # 3005580113-2022-00009).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.

• Brand Name: ZENITH® DISSECTION ENDOVASCULAR STENT
• 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13589482
• Report Number: 3002808486-2022-00139
• Device Sequence Number: 6062051
• Product Code: MIH
• UDI-Device Identifier: 10827002474939
• UDI-Public: (01)10827002474939(17)240812(10)E4145541
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 08/12/2024
• Device Model Number: G47493
• Device Catalogue Number: ZDES-36-180-US
• Device Lot Number: E4145541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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: Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male