MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a regent heart valve was selected for implant.Post deployment, both leaflets failed to open and remained frozen in place.When the physician could not get either leaflet to move, he explanted the valve and replaced it with a tissue valve.There was a significant delay in the procedure due to this event, but the procedure was completed with no further issues.The leaflets finally opened and moved on further attempts after removing from the patient.No adverse events were noted and patient was reported to be stable.

Manufacturer Narrative

Additional information: d10, h3, h6, h10.An event of the leaflets being immobile after implant was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.

Manufacturer Narrative

Additional information: h10.An event of the leaflets being immobile after implant was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.Please note that per the instructions for use, artmt100078770 version a ¿do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications.Use a st.Jude medical¿ leaflet tester to gently test valve leaflet mobility.¿.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 9717053
• MDR Text Key: 191606220
• Report Number: 2648612-2020-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 7137985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 74