MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM REGENT¿; HEART-VALVE, MECHANICAL

Model Number AGFN-756

Device Problems Material Erosion (1214); Defective Device (2588); Physical Resistance/Sticking (4012)

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

Event Date 10/02/2018

Event Type  malfunction  

Event Description

Patient brought to surgery and placed under general anesthesia.Per surgeon's notes: all the sutures were passed through the sewing ring and the valve was seated in place.As i was tying the knots with the core knot, it became apparent that some of the pledgets were interfering with the motion of the leaflets.Also where the root enlargement was performed, the valve would still fit tightly and some of the core knots would erode through the bovine pericardial patch.I also tried to rotate the valve to prevent interference of the leaflet motion, but somehow it did not work.I decided to explant the valve.All the sutures were cut and all the pledgets were carefully removed.Manufacturer response for heart-valve, mechanical, sjm regent¿ (per site reporter).Surgery inventory coordinator to follow-up.

• Brand Name: SJM REGENT¿
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8119547
• MDR Text Key: 128895135
• Report Number: 8119547
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: (01)05414734006095(17)211002
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 23AGFN-756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Weight: 99