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 Insufficient Information (3190)

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

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported from fda safety report on an unknown date a 23mm regent heart valve w/flex cuff was implanted.The valve was explanted on an unknown date because it did not function properly.Patient status is unknown.Additional information cannot be obtained.

Manufacturer Narrative

Additional information: h6.As reported in a fda safety report one patient had a regent valve replaced because it "did not function properly" after an unknown length of time.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.An initial review of complaints data was reviewed on (b)(6) 2020 as a component of the complaint handling risk review per wi 90591806.The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.

• 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: 10000507
• MDR Text Key: 189708950
• Report Number: 2648612-2020-00050
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/28/2020,05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2014
• Device Model Number: 23AGFN-756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/28/2020
• Distributor Facility Aware Date: 02/28/2020
• Date Report to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention