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

Model Number 21AT-103

Device Problems Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Hemolytic Anemia (2279); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported on 21 april, 2021, on a unknown date, a patient underwent an explant procedure of their 21 mm sjm 21 mm tef cuff aortic valve originally implanted (b)(6) 1997 due to aortic stenosis (as).(b)(6) 2021, the patient became aware of shortness of breath during exertion and visited outpatient department of cardiology.Hemolytic anemia related to impaired blood flow in the mechanical valve was suspected, and avr was diagnosed after close examination.The patient remained hemodynamically stable during the procedure and is in stable condition postoperatively.Upon explant, no thrombus was observed, but a slight pannus-like ingrowth was confirmed on the inflow side.The surgeon was suspecting as from opening limitation of the leaflets, but there was not much pannus observed, and no thrombus either.Therefore, the surgeon is requesting analysis on whether there is problem in the mechanical movement of the valve.

Manufacturer Narrative

Additional information: d9, g3,g6, h2, h3, h6, h10.Explant was reported due to hemolytic anemia.The investigation found that there was fibrous pannus ingrowth on the outflow surface, which extended onto the orifice but not into the inner diameter of the valve.No acute inflammation or calcifications were present within the tissue.The mechanical leaflets were freely mobile and opened and closed completely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The pannus ingrowth, if more severe while implanted, could have contributed to device malfunction; however the returned state of the valve had no impediment to leaflet function and the cause of the reported event could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE W/TEFLON CUFF
• 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: 11822795
• MDR Text Key: 251412043
• Report Number: 2648612-2021-00048
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21AT-103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR