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

Model Number 27MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 27mm masters valve was selected for implant in the mitral position.After positioning, the posterior leaflet alternated between mobile and immobile.The anterior native leaflet had been completely resected, and the posterior native leaflet was diminutive but imbricated in the pledgeted sutures.There was no visible tissue on either side of the valve which might have caused the masters leaflet immobility.The masters valve was explanted, and a tissue valve was implanted (model unknown).Ex vivo, the leaflets were still immobile and had to be forced manually in order to move.Per report, the bypass time was extended, and the patient is reported to be recovering.

Manufacturer Narrative

An event of leaflet immobility was reported.The leaflets were mobile and morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Hydrodynamic testing at the time of manufacturing and upon return to abbott 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.

Event Description

On (b)(6) 2019, a 27mm masters valve was selected for implant in the mitral position.After positioning, the posterior leaflet alternated between mobile and immobile.The anterior native leaflet had been completely resected, and the posterior native leaflet was diminutive but imbricated in the pledgeted sutures.There was no visible tissue on either side of the valve which might have caused the masters leaflet immobility.The masters valve was explanted, and a 27mm magna ease tissue valve was implanted.Ex vivo, the masters leaflets were still immobile and had to be forced manually in order to move.Per report, the bypass time was extended an additional 99 minutes, and the patient is reported to be recovering.There were no adverse patient consequences.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8561738
• MDR Text Key: 143448631
• Report Number: 2648612-2019-00034
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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 Expiration Date: 01/20/2024
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 6819355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• 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: 59 YR