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

Model Number 27MECJ-502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Septic Shock (2068)

Event Date 04/18/2017

Event Type  Death  

Manufacturer Narrative

An event of patient death 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 Description

On (b)(6) 2016, a mitral valve replacement was performed and a 27 mm masters series valve was implanted.Per report from the patient's relative, the physician injured the patient's lung during the operation and the patient died of sepsis on (b)(6) 2017.Per report from the physician, the mitral valve was functioning normally and the patient died from several comorbidities that were exacerbated by a fall the patient had.The death had nothing to do with the normally functioning valve.No additional information, including the patient's weight will be provided.

• 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 ; 6517564470
• MDR Report Key: 7115911
• MDR Text Key: 94784853
• Report Number: 2648612-2017-00107
• 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
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/20/2020
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 5133202
• Other Device ID Number: 05414734006453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 60 YR