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)

Event Type  Injury  

Event Description

Description of event according to article: initial repair of the taaa was done by bevar where a 4-branched stent graft was created by the physician via modification of a tx2.The modification included sewing on viabahn covered stents (from another manufacturer) on the tx2 stent graft to create 4 directional branches.After the procedure there was initially a decrease in sac diameter, but at 35 months after the procedure the aneurysm sac had enlarged.Enlargement continued.Patient outcome: the stent grafts remained in the patient as intended occult endoleak 4 years after the initial procedure, endovascular repair by bevar was needed.

• 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: 15673359
• MDR Text Key: 302422548
• Report Number: 3005580113-2022-00111
• 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: Physician
• Type of Report: Initial
• Report Date: 10/26/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2022
• Distributor Facility Aware Date: 10/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male