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

Model Number 21MHPJ-505

Device Problem Fracture (1260)

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

Event Date 10/03/2022

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) 2022, a 21mm sjm masters series hemodynamic plus valve was implanted into a patient.After the valve was implanted, the leaflet on the valve broke.The valve was removed and replaced with 21mm epic supra valve.No additional information was provided.

Event Description

It was reported that on (b)(6) 2022, a 21mm sjm masters series hemodynamic plus valve was implanted into a patient.After the valve was implanted, the leaflet on the valve broke.The valve was removed and replaced with 21mm epic supra valve.Subsequent to the previously filed report, additional information was received.It was reported that when the leaflet was implanted, it was being rotated with rubber shrouded forceps, and it fractured into multiple pieces.All pieces were recovered from patient anatomy.

Manufacturer Narrative

An event of valve leaflet fracture during implantation was reported.The device was returned to abbott for investigation and one leaflet was dislodged and fractured while the other leaflet was still in the orifice.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported event could not be conclusively determined but may have been caused by some external force being applied to the valve which overstressed the carbon material.There is no indication of a product quality issue with regards 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: 15694781
• MDR Text Key: 302701619
• Report Number: 2135147-2022-01845
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734054201
• UDI-Public: 05414734054201
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21MHPJ-505
• Device Catalogue Number: 21MHPJ-505
• Device Lot Number: 8131908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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