MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. SOLITAIRE STENT; CATHETER, THROMBUS RETRIEVER

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2022

Event Type  malfunction  

Event Description

The solitaire stent broke off end of wire and is now in patient's right ica (internal carotid artery).An attempt to snare and retrieve stent was not successful.

• Brand Name: SOLITAIRE STENT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 15334481
• MDR Text Key: 299050400
• Report Number: 15334481
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Sex: Female
• Patient Weight: 62 KG