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

Model Number 27M-101

Device Problem Gradient Increase (1270)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964)

Event Date 06/29/2018

Event Type  Injury  

Event Description

In 1979, a mitral valve replacement (mvr) was performed and a tissue valve (model and size unknown) was implanted in the patient¿s mitral position.On (b)(6) 1990, re-do mvr was performed and this 27mm mechanical heart valve was implanted.Since 2015, the valve pressure gradient had been gradually increasing.In 2016 (on an unknown date), perivalvular leakage was confirmed.On (b)(6) 2018, re-do mvr was performed again and this valve was explanted.Upon explant of this valve, the sewing cuff of this valve had been detached from the mitral annulus.Calcification was observed on the patient¿s native annulus and the tissue had become disrupted.A 29mm ats open pivot bileaflet heart valve was implanted as the replacement.Postoperatively, the patient has been in stable condition with no complications.

Manufacturer Narrative

An event of high gradient and paravalvular leakage was reported.The reported calcification was confirmed.Morphological and histopathological examination found fibrous pannus ingrowth on the inflow surface, limited to the sewing cuff, and focally calcified.The leaflets opened and closed completely and easily.No inflammation, thrombi or vegetations were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the reported event remains unknown; however, there was no evidence of device malfunction and information from the field indicated the tissue of the native annulus was calcified and disrupted.

Event Description

In 1979, a mitral valve replacement (mvr) was performed and a tissue valve (model and size unknown) was implanted in the patient¿s mitral position.On (b)(6) 1990, re-do mvr was performed and this 27mm mechanical heart valve was implanted.Since 2015, the valve pressure gradient had been gradually increasing.In 2016, perivalvular leakage was confirmed.On (b)(6) 2018, re-do mvr was performed and this valve was explanted.Upon explant of this valve, the sewing cuff of this valve had detached from the mitral annulus.Calcification was observed on the patient¿s native annulus and the surrounding tissue had become disrupted.A 29mm ats open pivot bileaflet heart valve was implanted as the replacement.Postoperatively, the patient has been in stable condition with no complications.

• Brand Name: SJM 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7758079
• MDR Text Key: 116286456
• Report Number: 2648612-2018-00060
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 27M-101
• Device Catalogue Number: 27M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/1990
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR