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

Model Number	19AECJ-502
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
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 (b)(6) 2019, a 19mm masters series valve was selected for implant.During placement of the valve holder was removed and one of the leaflets broke and fell down into the left ventricle cavity.The valve was removed and exchanged for a 17mm masters series valve.There was a clinically significant delay in procedure.The patient was reported to be instable condition.
Additional Manufacturer Narrative
The reported event of a "broken" leaflet could not be confirmed.The results of the investigation are inconclusive since 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.Please note, per the instructions for use artmt100122073 ver.A, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm¿ masters series mechanical heart valve sizes, use the smaller size sjm¿ masters series mechanical heart valve." "to minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.".
Additional Manufacturer Narrative
Additional information: d10, h3, h6.The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and fractured.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 leaflet dislodgment and fracture 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: 9547306
• Report Number: 3003681312-2020-00001
• Device Sequence Number: 2245876
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 01/21/2024
• Device Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: 6822431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/12/2020; 08/06/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/16/2020; 08/06/2020
• 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: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 48