MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47444
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: the patient was being treated for aaa on (b)(6) 2021.The concern was that the patient had very narrow and calcified vessels throughout.The initial part of procedure was to dilate up the vessels.They used 14, 16, 18, 20 and 22 fr dilators that passed with some resistance but were able to pass.The physician decided to try this device and in doing so was not able to pass it much past the common iliac.While doing that, the patient became slightly unstable.So, he removed the device and put up a 32 coda balloon and inflated it to determine if there were any ruptures of the vessel.He stabilized the patient and did not notice any leaks or ruptures initially.He then placed a gore abdominal device to treat the upper area.When finished on the same side that our device went up, he withdrew the sheath back and did another angio run.He then observed a small external iliac rupture which he proceeded to fix with gore viabonds to cover it.It could not be determined exactly what caused the small rupture.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• 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: 11626841
• Report Number: 3005580113-2021-00055
• Device Sequence Number: 17018309
• Product Code: MIH
• UDI-Device Identifier: 10827002474441
• UDI-Public: (01)10827002474441(17)230310(10)E3960830
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/07/2021
• Report Date (Section F): 04/02/2021

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: 03/10/2023
• Device Model Number: G47444
• Device Catalogue Number: ZDEG-P-28-82-PF-US
• Device Lot Number: E3960830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1