MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number 15MHPJ-505

Device Problems Backflow (1064); Insufficient Information (3190)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2021, a 15mm masters series hemodynamic plus valve was received by abbott.The valve appeared to have been explanted and had tissue retained upon arrival.The patient was reported to have discharged in stable condition.Additional information received on 30 march 2021 reported that the valve was implanted on (b)(6) 2016 and explanted on (b)(6) 2021 due to aortic insufficiency.

Manufacturer Narrative

Explant was reported due to aortic insufficiency.The investigation found that the mechanical leaflets opened and closed completely and were freely mobile.There was patchy pannus formation on the sewing cuff, but it did not impinge upon the leaflets.No acute inflammation or significant calcifications were present.Areas of chronic inflammation were seen in the sewing cuff material.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 aortic regurgitation could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 11610817
• MDR Text Key: 243725129
• Report Number: 3007113487-2021-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2017
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Device Lot Number: 3698000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention