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

Model Number	G35367
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a (b)(6) year old male patient underwent a tvar procedure in which the zenith alpha thoracic endovascular graft proximal components, g35367, was used.The last graft piece, g35367, was used for bridging between two grafts as the proximal graft was too short with the distal piece.When the physician finished and rotated the delivery system the nose cone of the device inner white cannula came off and stayed on the wire end of the graft.Leaving the nose cone and inner cannula in the patient.The physician then advanced a longer and larger sheath and snared the sheath to remove from the patient.Additional information received 20mar2020: after releasing the stent graft, the physician retrieved the inner system and left the outer sheath in order to perform ballooning.When the inner system was taken out, it was noted that the system only contained the grey positioner along with the handle and the tip assembly (dilator tip and cannula) was left in patient.There was very torturous anatomy and we were well in the arch around zone 2.Some difficulty retrieving device over the arch but as expected with the anatomy and size of aneurysm.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 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: 9937424
• Report Number: 3005580113-2020-00350
• Device Sequence Number: 16768454
• Product Code: MIH
• UDI-Device Identifier: 10827002353678
• UDI-Public: (01)10827002353678(17)230113(10)E3938709
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2020
• Report Date (Section F): 04/08/2020

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: 01/13/2023
• Device Model Number: G35367
• Device Catalogue Number: ZTA-P-42-173-W
• Device Lot Number: E3938709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 04/08/2020