MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 17AGN-751

Device Problem Obstruction of Flow (2423)

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

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 17mm regent heart valve was selected for implant.During placement the leaflets did not open properly and the valve was exchanged for a 19mm regent heart valve.It was reported that there was a clinically significant delay in the procedure.The patient was reported to be in stable condition and no patient consequences were reported.

Manufacturer Narrative

An event of the leaflets not opening properly was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 9008232
• MDR Text Key: 178311317
• Report Number: 3003681312-2019-00005
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 17AGN-751
• Device Catalogue Number: 17AGN-751
• Device Lot Number: 6832186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1