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

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

An event of thrombus on the mechanical valve leaflet was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

(b)(6).It was reported that a 22mm sjm mechanical aortic heart valve was successfully implanted in the patient in 2008.The patient has the following comorbidities: non-ischemic cardiomyopathy, congenital heart defect and atrial fibrillation.The patient was hospitalized on (b)(6) 2021 due to a stroke.It was noted per review of the medical records provided that a thrombus was observed on one of the sjm valve leaflets during a transesophageal echocardiogram (tee) completed on (b)(6) 2021.There was elevated gradients noted on the aortic prosthesis, there was a echodensity visible and overall the entire aortic valve looked brighter with no discrete leaflet movement.The thrombus was noted on the left mechanical valve leaflet, possibly on the sewing ring.The patient was deemed high risk for surgery, so the patient's heparin was stopped and they were treated with tissue plasminogen activator (tpa).The etiology of the suspected stroke likely embolic.The patient was discharged from the hospital on (b)(6) 2021.No additional information was provided.

• 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12081074
• MDR Text Key: 268066210
• Report Number: 2648612-2021-00072
• Device Sequence Number: 1
• Product Code: LWQ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• 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