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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of valvular explant was reported.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.Based on the information received, the cause of the reported incident could not be conclusively determined. .
Event or Problem Description
On (b)(6) 2016, a 19mm masters valve was implanted.On (b)(6) 2019, the 19mm masters valve was explanted.Additional information was requested, but not made available by the hospital or physician.
Additional Manufacturer Narrative
An event of valve explant was reported.Morphological and histopathological examination revealed found that the mechanical leaflets opened and closed completely and easily.There was minimal pannus formation mostly limited to the sewing cuff, which focally began to encroach onto the valve orifice, but not into the inner diameter.No inflammation or significant calcifications were found.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.The reason for the device explant was never reported.
Event or Problem Description
On (b)(6) 2016, a 19mm masters valve was implanted.On (b)(6) 2019, the 19mm masters valve was explanted.The initial information was submitted by the explanting md who is different from the implanting md in another state.Efforts to obtain additional information were requested, but not made available by the hospital or physician.

• 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: 8346302
• Report Number: 2648612-2019-00012
• Device Sequence Number: 1867068
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 09/22/2019
• Device Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: 4799038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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: 50 YR