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

Catalog Number UNKNOWN

Device Problem Pressure Problem (3012)

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

Event Description

Description of event according to initial reporter: patient underwent tevar with stent-graft coverage from 2 cm distal to the lsca to the celiac artery.Two ztas are used.The proximal graft landed 2.5 cm distal to the intended landing site (lsa).At 6 weeks post-operation, cta revealed focal retrograde dissection.The proximal zta had migrated 2 cm further distally and was now 4.5 cm (the article says mm, but it must be cm) distal to the lsa.Endovascular reintervention is performed to place two stent grafts from an other manufacturer.Patient outcome: there was imprecise deployment, graft migration and retrograde dissection.

• 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: 15485081
• MDR Text Key: 300580432
• Report Number: 3005580113-2022-00103
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Distributor Facility Aware Date: 09/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male