MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM 19MM EXP CUFF AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number 19AEC-102

Device Problem Obstruction of Flow (2423)

Patient Problem Corneal Pannus (1447)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

An event of dysfunction of one of the leaflets due to pannus ingrowth and explant of the valve after 27 years was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 1993, a 19mm sjm mechanical heart valve expanded cuff was implanted in the patient's aortic position.On an unknown date, dysfunction of one of the leaflets due to pannus ingrowth was confirmed on (b)(6) 2020, the sjm mechanical heart valve was explanted.Upon explant, pannus growth was observed, which impeded valve mobility.A competitor's 19mm mitroflow was successfully implanted.No patient consequences were reported.

• Brand Name: SJM 19MM EXP CUFF AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9786541
• MDR Text Key: 190335623
• Report Number: 3001743903-2020-00001
• Device Sequence Number: 1
• Product Code: LWQ
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/1996
• Device Model Number: 19AEC-102
• Device Catalogue Number: 19AEC-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1992
• 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: 75 YR