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

Model Number	G35335
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: patient presented with a type b dissection and provided diameters, size, etc.After the physician further reviewed the films, a type a dissection was observed.The physician decided to treat ascending repair with a frozen elephant trunk anagrade.Sizes were discussed and the physician needed a 26 or 28, but these are not made by cook (for this particular device).The dm called back and stated he had a 26x105; however in a alpha graft.This graft was used.Ivus was available.No imaging available while performing the open procedure.When the physician prepares to deliver the graft, the dm noted to the physician that he did not have visibility of the graft.Thus, the dm told the physician to measure to determine where the end of the graft is precisely located.The graft was measured to realize the end of the graft.At this point the device was delivered and most likely too far.The physician went to un-sheath and there was a lot of tension built up.As the physician is unsheathing, he is actually pushing the graft further down the aorta.When the physician is un-sheathing the graft, the physician notes he can not see the end of the graft.The dm stated he will not be able to pull the graft back due to the nature of the dissection.The physician states he will just have to deploy the graft in its current position.After deploying the graft, it deploys fine.The physician sows up.Ivus is used to see the where the graft 's location is.Ivus indicates the visceral vessels were covered.The physician calls a vascular surgeon to come to the case and they performed an exploratory procedure in the aorta to locate the graft.They determined the graft must be explanted.An incision was made in the abdominal aorta and they were able to remove the graft and close-up the incision.The graft was explanted and the physician's finished the arch repair.Patient outcome: the patient is recovering okay at this point.

• 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: 13150974
• Report Number: 3005580113-2022-00006
• Device Sequence Number: 4118033
• Product Code: MIH
• UDI-Device Identifier: 10827002353357
• UDI-Public: (01)10827002353357(17)240217(10)E4073742
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022
• Report Date (Section F): 01/03/2022

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: 02/17/2024
• Device Model Number: G35335
• Device Catalogue Number: ZTA-P-26-105-W
• Device Lot Number: E4073742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/12/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2022
• Date Device Manufactured: 02/17/2021
• 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; Required Intervention
• Patient Sex: Female