MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Catalog# is unknown but referred to as zenith alpha graft.

Event Description

Description of event according to initial reporter: a secondary intervention is scheduled on a case from a couple years ago.The case is schedule on (b)(6) 2020 and reason for the secondary intervention is for component separation of zenith alpha grafts, which is believed to be caused by the tortuosity of the anatomy.It was further reported, patient originally had a tevar on (b)(6) 2017 where a zta-p-40-167-w as implanted proximally, followed by zta-p-46-125-w hybrid debranching/tevar on (b)(6) 2018 zta-36-32-161-w placed distally, then telescoped zta-pt-42-38-225-w, followed by zta-pt-42-38-173 into the zta-p-40-167-w.Secondary intervention due to separation of the zta-36-32-161-w from the zta-pt-42-38-225 placed zta-pt-42-38-225-w followed distally with a zta-pt-38-34-217-w.Outcome reported not symptomatic from prior secondary intervention.Aneurysm growth present due to separation.No endoleak documented between 6 mo.Visits.Imaging prior and subsequent to the secondary intervention? 6 mo.Ct¿s.Working on gathering this info.Aneurysm reportedly measures 6.3 c.Patient outcome subsequent to the secondary intervention reportedly went well.Patient went home on day two doing well.30 day ct to be done in (b)(6) 2021.No planning or sizing information be provided, initial procedures in 2017 and 2018.Furthermore, tortuosity was present prior to first tevar in 2017.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10994266
• MDR Text Key: 222337239
• Report Number: 3005580113-2020-00458
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2020
• Distributor Facility Aware Date: 11/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention