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

Model Number 25MECJ-502

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, a mitral valve replacement was performed.Per report, the patient's native valve appeared rheumatic.The anterior leaflet and chordae were resected and this 25 mm sjm masters series valve was implanted.The valve was noted to be functioning immediately after it was implanted on echo until the patient started to come off bypass until 2l flow one of the leaflets froze.Per report, it was initially thought that the leaflet was catching the papillary muscle and impeding performance; however while weaning from cpb, an occlusive clot in the descending aorta was noted.The patient was placed back on bypass for the removal of the valve and immediately upon opening despite full heparinization, there were strands noted.The 25 mm valve was removed, the posterior leaflet and chordae were resected, and a larger 27 mm masters series valve was implanted.It was reported the patient was on bypass for an additional hour or more to complete the entire surgical procedures.Per report, the patient had multiple existing health problems, including a thrombolytic disorder.The patient was reported to be in stable condition and transitioning to coumadin.

Manufacturer Narrative

The results of this investigation concluded both leaflets were fully mobile and no damage was found to the orifice, recessed pivot areas, or leaflets.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and the analysis performed.The cause of the reported event remains unknown; however, information from the field indicated a larger 27 mm masters series valve was implanted.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 1165175644
• MDR Report Key: 6187106
• MDR Text Key: 62786537
• Report Number: 2648612-2016-00124
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: 5579209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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: 49 YR