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

Model Number 27AHPJ-505

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

The results of this investigation indicated the mechanical valve was able to be manually rotated without difficulty.Both leaflets were fully mobile and no damage was found to the orifice, recessed pivot areas, or leaflets.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 smaller 25 mm masters series valve was implanted.

Event Description

After a 27 mm masters series valve was implanted, the valve was unable to be rotated and the leaflets did not open.The valve was explanted and replaced with a 25 mm masters series valve.Bypass time was extended 20 minutes due to this; the patient is reported to be recovering.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6597208
• MDR Text Key: 76125367
• Report Number: 3007113487-2017-00015
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2014
• Device Model Number: 27AHPJ-505
• Device Catalogue Number: 27AHPJ-505
• Device Lot Number: 2787710
• Other Device ID Number: 05414734006408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2009
• 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