MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number S3UCM226A

Device Problems Mechanical Problem (1384); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

Valve would not transverse the sheath.So, a new valve and delivery system had to be opened to complete the procedure.Rep was present for the case and took the product failure with him for evaluation.Product had patient contact but no patient harm.Manufacturer response for valve tavr 9750tfx ultra 26mm, (brand not provided) (per site reporter).The product was picked up by the field rep for evaluation.

• Brand Name: SAPIEN 3
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12083885
• MDR Text Key: 258962930
• Report Number: 12083885
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: S3UCM226A
• Device Catalogue Number: S3UCM226A
• Device Lot Number: 7610820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA