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

Model Number 19AHPJ-505

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 10/04/2019

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) 2003, a 19mm masters valve was implanted in the supra-annular position and pledgets were used on the inflow side of the valve.No calcification was observed on the aortic annulus.On (b)(6) 2019, the valve was explanted.The physician reported pannus on the pivot guard extending to the leaflet recess.Of note, the patient was prescribed an anticoagulant; however, was temporarily discontinued due to an obturator hernia.The user suggests this may have induced thrombus formation extending over the leaflet leading to leaflet obstruction.

Manufacturer Narrative

The reported event of pannus on the valve and impeded leaflet mobility was confirmed.The investigation found pannus on the orifice rim, but it did not extend onto the leaflets.One leaflet had limited mobility and thrombus was present in the pivot recesses of one of the mechanical leaflets.No 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 thrombus present in the recessed pivot areas could caused the limited mobility of the leaflet.

Event Description

On (b)(6) 2003, a 19mm masters valve was implanted in the supra-annular position and pledgets were used on the inflow side of the valve.No calcification was observed on the aortic annulus.On (b)(6) 2019, the valve was explanted.The physician reported pannus on the pivot guard extending to the leaflet recess.Of note, the patient was prescribed an anticoagulant; however, was temporarily discontinued due to an obturator hernia.The user suggests this may have induced thrombus formation extending over the leaflet leading to leaflet obstruction.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9219715
• MDR Text Key: 163187746
• Report Number: 2648612-2019-00081
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2007
• Device Model Number: 19AHPJ-505
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: 0002623537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR