MAUDE Adverse Event Report: NVT GMBH ALLEGRA; DEPRESSOR, TONGUE, NON-SURGICAL

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that immediately following the implant of a 31 mm nvt alegra transcatheter aortic valve, the valve embolized in the direction of the aorta after retrieval of the delivery catheter system (dcs).The valve was held with a snare while an additional valve was implanted.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ALLEGRA
• Type of Device: DEPRESSOR, TONGUE, NON-SURGICAL
• Manufacturer (Section D): NVT GMBH
• MDR Report Key: 17535994
• MDR Text Key: 321190158
• Report Number: MW5142886
• Device Sequence Number: 1
• Product Code: FMA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1