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

Model Number 21AGFN-756

Device Problems Backflow (1064); Gradient Increase (1270)

Patient Problems Aortic Regurgitation (1716); Death (1802); Dyspnea (1816); Unspecified Infection (1930)

Event Date 09/23/2020

Event Type  Death  

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

On an unknown date in (b)(6) 2013 a 21mm sjm regent heart valve w/flex cuff was implanted.On (b)(6) 2020, the patient presented to hospital experiencing shortness of breath.Upon examination, severe aortic regurgitation and increase gradient was noted.The patient was diagnosed with respiratory infection and was transferred to the intensive care unit.On (b)(6) 2020, the patient went into cardiac arrest and ending up dying.The patient's cause of death was due to an aortic valve thrombus and aortic regurgitation.Additional information has been requested.

Manufacturer Narrative

An event of thrombus, regurgitation and patient death was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of thrombus, regurgitation and patient death was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10853906
• MDR Text Key: 216673668
• Report Number: 2648612-2020-00123
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 53 YR