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

Model Number 23CAVGJ-514 00

Device Problems Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2002, a 23mm masters valve was implanted.Patient maintains inr around 2.0 and has been compliant.On (b)(6) 2022, decreased leaflet mobility was observed and medical treatment was administered.The patient is planned for a procedure to "either clean out valve or replace" but this has not been scheduled.No patient consequences were reported.

Manufacturer Narrative

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

Manufacturer Narrative

An event of decreased leaflet mobility was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.D6: implant date corrected h6: code 2120 (urinary tract infection) was removed.Code 4582 (no clinical signs, symptoms or conditions) was added.H6: code 2993 (adverse event without identified device or use problem) was removed.Code 2507 (incomplete coaptation) was added.

• 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; 177 county road b east; woodridge MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15474028
• MDR Text Key: 300556232
• Report Number: 2135147-2022-01334
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006149
• UDI-Public: 05414734006149
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23CAVGJ-514 00
• Device Catalogue Number: 23CAVGJ-514 00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/05/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female