MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS HP MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

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

Patient Problems Dyspnea (1816); Valvular Stenosis (2697)

Event Date 04/21/2021

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

On an unknown date in 2005 a masters hp mechanical heart valve was implanted in the aortic position.Over time the patient developed aortic stenosis and shortness of breath due to pannus overgrowth that obstructing the opening of the valve and on (b)(6) 2021, the valve was explanted.A 31mm magna mitral ease was implanted.The patient was reported to be in stable condition and is recovering in the intensive care unit (icu).

Manufacturer Narrative

Additional information: d9, h3, h6, h10 explant was reported due to stenosis.The investigation found that there was fibrous pannus ingrowth on the inflow surface which extended over the sewing ring and narrowed the inflow diameter.The pannus was calcified.No thrombus, vegetations, or inflammation were present.The mechanical leaflets were freely mobile and opened and closed completely.The pannus which narrowed the inflow diameter could have contributed to the reported stenosis.

• Brand Name: MASTERS HP MECHANICAL HEART VALVE
• 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: 11792285
• MDR Text Key: 250863594
• Report Number: 2648612-2021-00050
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 75