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

Model Number 19AGFN-756

Device Problems Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Insufficiency (1715); Dyspnea (1816); Thrombosis (2100)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2009, a 19mm regent heart valve was implanted.On 5 november 2019, the valve was explanted due to increased dyspnea, severe aortic insufficiency, valve dysfunction, and thrombosis on the valve.A competitor's 21mm carpentier edwards inspiris aortic tissue valve was successfully implanted.

Manufacturer Narrative

Additional information sections: b5, d10, g4, g7, h2, h3, h6, h10.Explant was reported due to dyspnea, aortic insufficiency, valve dysfunction, and thrombosis on the valve.The investigation found that there was slightly limited mobility of one mechanical leaflet with thrombus in one pivot recess.There was pannus with calcifications that was limited to the sewing cuff.No acute inflammation was present.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.The limited mobility of one of the leaflets with a thrombus in one pivot recess could have contributed to the aortic insufficiency reported.

Event Description

On (b)(6) 2009, a 19mm regent heart valve was implanted.On(b)(6) 2019, the valve was explanted due to increased dyspnea, severe aortic insufficiency, valve dysfunction, and thrombosis on the valve.A competitor's 21mm carpentier edwards inspiris aortic tissue valve was successfully implanted.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9376917
• MDR Text Key: 168044913
• Report Number: 2648612-2019-00095
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 2991222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention