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

Model Number	25MECJ-502
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 25mm masters series valve was selected for implant.After placing the valve the posterior leaflet was interfering with the leaflet opening and closing and the valve was removed.A 29mm master series valve was selected for implanted and while rotating the valve the leaflet cracked and the valve was removed from the patient and replaced with another 29mm masters series valve.There was a clinically significant delay in procedure due to the removal of the first 2 valves.The patient was reported to be stable condition.Manufacturer report number: 2648612-2020-00038.
Additional Manufacturer Narrative
Additional information: d10, h3, h6; an event of the leaflet mobility being interfered with by the native posterior leaflet 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 at the time of commercialization.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.Information from the field indicated that the leaflet movement was inhibited due to interference by the posterior leaflet.

• 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: 9977148
• Report Number: 2648612-2020-00037
• Device Sequence Number: 11282076
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: 6926356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 29MECJ-502, 18290440.; 29MECJ-502, 18290440.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR