MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES EXPANDED HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Catalog Number 25MHPJ-505

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 25mm sjm masters series hemodynamic plus valve was chosen for a procedure.During procedure, it was noted the valve had expired on 16 december 2023.The occupational therapy (ot) staff nurses were aware of the expiry prior to implantation and informed the implanter, but implanter acknowledged and proceed to implant the expired mechanical valve.The expired valve was implanted.The initial procedure date was planned for (b)(6) 2023, but it got delayed to (b)(6) 2023.The valve was delivered to the hospital on 06 december 2023.There were no immediate health consequences to the patient, but the doctor was concerned on possible long term outcomes.The patient was reported stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of improper or incorrect procedure or method (expired product used) was reported.It was reported that the valve was delivered to the hospital on (b)(6) 2023 and the valve had expired on (b)(6)2023.The initial procedure date was planned for (b)(6) 2023, but it got delayed to (b)(6) 2023.The staff nurses were aware of the expiry prior to implantation and informed the implanter, but implanter acknowledged and proceed to implant the expired mechanical valve.The expired valve was implanted.Based on the information reviewed, the reported improper or incorrect procedure or method (expired product used) was due to the user error as the implanter using an expired hemodynamic plus (hp) valve.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MASTERS SERIES EXPANDED HEMODYNAMIC PLUS VALVE
• 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: 18498129
• MDR Text Key: 333205324
• Report Number: 2135147-2024-00205
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2023
• Device Catalogue Number: 25MHPJ-505
• Device Lot Number: 6782895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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 Age: 58 YR
• Patient Sex: Female