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

Model Number	27MECJ-502
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2020, a patient underwent a double valve replacement (dvr) using a 27 mm masters series valve (mecj) in the mitral position and a 19 mm masters series valve (aecj ) in the aortic position.During the post-operative observation the physician found a moderate to severe paravalvular leakage around the sewing ring.The physician decided to re-implant the mitral valve with a new prosthesis.The patient did not experience any serious injuries.The 27 mm mitral valve was carefully explanted from the patient and a new 27 mm masters series valve (mecj) was implanted in the mitral position.
Additional Manufacturer Narrative
An event of paravalvular leakage was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
An event of the paravalular leakage around the sewing ring was reported.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 and the product met all 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 MASTERS SERIES VALVE EXPANDED CUFF
• 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: 11194748
• Report Number: 2648612-2021-00007
• Device Sequence Number: 14512836
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 02/02/2025
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 7376079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 04/29/2021; 10/12/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 05/01/2021; 10/14/2021
• 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: Required Intervention