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

Model Number	G47496
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: "the tevar covered pieces were successfully deployed to cover entry tears to approx.2cm above celiac artery.Extended distally with zdes-46-184-us.I advised the doctor to use caution advancing any wires through the bare stent as they could go through the suture loops used to hold the stent together, but he said he advanced wires quickly and said that there was no way to tell.As i was explaining to the fellow and mdt rep why caution was needed the doctor advanced the (another manufacturers) catheter over the wire at which point the distal 2 stents of the zdes migrated up (cephalad).The doctor used a molding balloon (mdt reliant) that was gently inflated inside the zdes to pull the stent back down into place.".

• 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
• MDR Report Key: 15998588
• Report Number: 3005580113-2022-00139
• Device Sequence Number: 17806470
• Product Code: MIH
• UDI-Device Identifier: 10827002474960
• UDI-Public: (01)10827002474960(17)250913(10)E4304290
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 12/16/2022

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: 09/13/2025
• Device Model Number: G47496
• Device Catalogue Number: ZDES-46-185-US
• Device Lot Number: E4304290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/03/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Date Device Manufactured: 09/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/16/2022