MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MASTERS SERIES HP GELWEAVE VALSALVA; HEART-VALVE, MECHANICAL

Model Number VAVGJ-515

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

Leaflet of mechanical valve dislodged during explant.Leaflet retrieved by doctor.

• Brand Name: SJM MASTERS SERIES HP GELWEAVE VALSALVA
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9699332
• MDR Text Key: 178754046
• Report Number: 9699332
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA