MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALVE WITH TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number 27MTJ-503

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 27mm sjm masters series heart valve with teflon cuff was chosen for procedure.During the procedure, the valve was removed due to the size difference and there was difficulty parachuting the device into the annulus.The procedure was completed using a non-abbott valve as a replacement.No adverse patient effects were reported.The patient status was reported as stable.

Manufacturer Narrative

An event of difficulty parachuting the device into the annulus was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART VALVE WITH TEFLON CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16691288
• MDR Text Key: 312864301
• Report Number: 2135147-2023-01503
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053624
• UDI-Public: 05414734053624
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27MTJ-503
• Device Catalogue Number: 27MTJ-503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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