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

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problem Host-Tissue Reaction (1297)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, vegetation was found on eight patients, three of which had an unknown abbot valve implanted.Elevated pressure gradient or abnormal leaflet motion was also reported.The results of the investigation are inconclusive since 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

Reference manufacturing number: 2648612-2019-00106, 2648612-2019-00107.It was reported through a research article identifying abbott valves that may be related to a redo-surgery due to vegetation.Specific patient information is documented as unknown.Details are listed in the attached article, titled [value of computed tomography radiomic features for differentiation of periprosthetic mass in patients with suspected prosthetic valve obstruction].It was reported from the research article that vegetation was observed on eight patients from a cardiac computed tomography (ct) scan from january 2014 to august 2017.Elevated pressure gradient or abnormal leaflet motion were observed from echocardiography.Three of the patients were implanted with an unknown abbott valve and were treated with antibiotic treatment or a redo surgery.No patient complications were reported post treatment.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9434256
• MDR Text Key: 169796013
• Report Number: 2648612-2019-00108
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 11/21/2019
• 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): Other; Required Intervention