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

Model Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Thrombus (2101)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On an unknown date between the years of 1997 & 1998, a mechanical heart valve was implanted in the aortic position.On (b)(6) 2019, the patient underwent a re-do avr (aortic valve replacement) due to either pannus ingrowth or thrombus.The valve was explanted and replaced with a 21mm resilia inspiris valve.The procedure was completed with no health consequence to the patient.

Manufacturer Narrative

Microscopic examination revealed that sections of material removed from the pivot recesses consisted of organizing thrombus with areas of entrapped chronic inflammatory cells.There was no acute inflammation.Sections of the sewing cuff consisted of sewing cuff material with fibrous tissue in the interstices.There was no inflammation.Explant was reported due to either pannus or thrombus after an implant period of around 20 years.The investigation found that the leaflets were immobilized.Thrombus was present in both recessed pivot areas and on the leaflets.No acute inflammation or significant calcifications were present.The thrombus noted in the recessed pivot areas would have contributed to the leaflet immobilization.

• Brand Name: SJM MASTERS SERIES 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: 9207189
• MDR Text Key: 162811884
• Report Number: 2648612-2019-00086
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other