MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-PLYMOUTH) SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS; HEART-VALVE, MECHANICAL

Model Number 19AHP-105

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aortic Valve Stenosis (1717); Mitral Valve Stenosis (1965)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturer reference : 3005334138-2022-00095.It was reported that a 19mm and a 27mm mechanical heart valve hemodynamic plus was implanted in 1997 for a double valve replacement due to aortic and mitral stenosis.The 19mm sjm mechanical heart valve was implanted in an aortic position and the 27mm sjm mechanical heart valve was implanted in a mitral position.During follow up period, recurrence of aortic stenosis and mitral stenosis was observed since 2010.The patient was being monitoring continuously though, ambulation difficulty occurred since (b)(6) 2021.The redo mitral valve replacement (mvr) and aortic valve replacement (avr) were conducted on (b)(6) 2022.Pannus was proliferated and extended over the leaflets though, no issue for leaflet mobility was confirmed.After the explant, a 27mm sjm epic valve was implanted and unknown valve was implanted in aortic position.The patient has been recovering after the surgery and has been in stable condition.No additional information was provided.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturer reference : 3005334138-2022-00095.It was reported that a 19mm and a 27mm mechanical heart valve hemodynamic plus was implanted in 1997 for a double valve replacement due to aortic and mitral stenosis.The 19mm sjm mechanical heart valve was implanted in an aortic position and the 27mm sjm mechanical heart valve was implanted in a mitral position.During follow up period, recurrence of aortic stenosis and mitral stenosis was observed since 2010.The patient was being monitoring continuously though, ambulation difficulty occurred since (b)(6) 2021.The redo mitral valve replacement (mvr) and aortic valve replacement (avr) were conducted on (b)(6) 2022.Pannus was proliferated and extended over the leaflets though, no issue for leaflet mobility was confirmed.After the explant, a 27mm sjm epic valve was implanted and unknown valve was implanted in aortic position.The patient has been recovering after the surgery and has been in stable condition.No additional information was provided.

Manufacturer Narrative

An event of a stenosis, "ambulation difficulty", and pannus was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13582117
• MDR Text Key: 285982251
• Report Number: 3014918977-2022-00012
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19AHP-105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female