MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Catalog Number 25CAVGJ-514 00

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 25mm masters valve was selected for an implant.During the procedure, the physician discovered that the dimensions for the outer diameter of the valve was not 25mm and it's less than that and for the graft it was 31mm.The device was implanted in the patient.The patient is stable.

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 25mm masters valve was selected for an implant.During the procedure, the physician discovered that the dimensions for the outer diameter of the valve was not 25mm and it's less than that and for the graft it was 31mm.The device was implanted in the patient.The patient is stable.

Manufacturer Narrative

An event of the valve dimensions not being correct was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.However images of the valve were received for examination.In the two images received, a ruler is placed on the valve and appeared to be measuring the orifice of the valve, not the tissue anulus diameter.The orifice of the valve can measure below 25mm, it is the tissue anulus diameter which is expected to measure 25mm.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This includes measurement of the tissue annulus diameter during the manufacturing process, which was reported to measure 25.03mm, within specifications for a 25mm valve.The cause of the reported event appears to be due to a misunderstanding of the valve's measurements.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• 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: 18075106
• MDR Text Key: 327425745
• Report Number: 2135147-2023-04884
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006316
• UDI-Public: 05414734006316
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 9166969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• 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