MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, an unknown mechanical heart valve that was explanted for an unknown reason was received.No additional information was provided and initial reporter of event is unknown.

Manufacturer Narrative

Additional information for: g4, g7, h2, h3, h6, and h10.Explant was reported for an unknown cause.The investigation found that the leaflets opened and closed completely and were fully mobile.There was fibrous pannus ingrowth on the inflow surface of the orifice which did not impinge upon the leaflets.There was significant drying and shrinkage of the pannus.No inflammation or significant calcifications were present.It could not be determined if the pannus impinged upon the mechanical components or narrowed the inflow diameter, which could have caused or contributed to malfunction of the valve.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10864290
• MDR Text Key: 226172195
• Report Number: 2648612-2020-00125
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1