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

Model Number 27MECJ-502

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  Injury  

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 Description

On (b)(6) 2017, a 27mm masters series valve was implanted.On (b)(6) 2019, the valve was explanted due to leaflet obstruction and the valve was exchanged with a 27mm epic stented porcine valve.The patient has been discharged and no patient consequences were reported.

Manufacturer Narrative

The reported event of a "stuck" valve could not be confirmed.The investigation found that both leaflets opened and closed completely and easily.Pannus was present on the remains of the sewing cuff but did not impinge or obstruct the leaflets.No acute 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 at the time of commercialization.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V.; lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 9075774
• MDR Text Key: 158806259
• Report Number: 3003681312-2019-00006
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 5798388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR