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

Model Number	23MECJ-502
Medical Device Problem Codes	Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombus (2101)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On an unknown date, a (b)(6) year old female presented to the hospital with a diagnosis of rheumatic heart disease and severe mitral stenosis.The patient underwent balloon mitral valvotomy(bmv), but it was unsuccessful.On (b)(6) 2019, the patient underwent emergency mitral valve replacement and the mitral valve was replaced with a 23mm sjm masters series valve expanded cuff (sn: (b)(4)).On (b)(6) 2020, the patient presented to the hospital with breathlessness.Her prothrombin time and inr were in therapeutic range(inr was 2.8).However, her echocardiography showed a stuck valve due to acute thrombosis and the patient underwent successful thrombolysis and the patients anticoagulation dose was increased.On (b)(6) 2020, the patient presented with breathlessness again.The patient's prothrombin time was prolonged with prothrombin time test more than 100 seconds.The echocardiography showed an elevated mitral valve gradient.Fluoroscopy was done and it showed immobility of the prosthetic mitral valve leaflet.The patient underwent thrombolysis, but the thrombolysis failed to release the stuck valve.The physician decided to perform a re-do mitral valve replacement.On (b)(6) 2020, the patient underwent the re-do mitral valve replacement surgery and the valve was explanted and replaced with a 25mm epic stented porcine heart valve w/flexfit system.The intra-operative findings showed a stuck aortic side leaflet of the prosthetic valve due to thrombosis.The patient is doing well and was discharged 4 days after surgery.
Additional Manufacturer Narrative
Explant was reported due to thrombus and immobility of the leaflet.The investigation found that both leaflets moved freely and easily.No material was found in the recessed pivot areas or on the leaflets.Traces of pannus were present on the sewing cuff.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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: 10473149
• Report Number: 2648612-2020-00091
• Device Sequence Number: 11312386
• Product Code: LWQ
• UDI-Device Identifier: 05414734006170
• UDI-Public: 05414734006170
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 02/27/2024
• Device Model Number: 23MECJ-502
• Device Catalogue Number: 23MECJ-502
• Device Lot Number: 6881484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: 33 YR
• Patient Weight: 60