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

Model Number	27MJ-501
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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: 8561738
• Report Number: 2648612-2019-00034
• Device Sequence Number: 16528406
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR