MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC STENTED TISSUE VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-33M

Device Problems Biocompatibility (2886); No Apparent Adverse Event (3189)

Patient Problems Myocardial Infarction (1969); Pleural Effusion (2010); Pulmonary Edema (2020); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/26/2021

Event Type  Death  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on an unknown date an epic stented tissue valve was implanted.Post procedure, a valve thrombosis was noted in the left and right cavities.The patient was in the intensive care unit (icu) on extracorporeal membrane oxygenation (ecmo).A hemorrhage without heparin induced thrombocytopenia was reported.Upon autopsy review, it was noted that the patient had a pleural effusion, inferior lateral white myocardial infarction, clots adhered at the tricuspid valve as well left atrium and mitral valve.Additional information has been requested and is pending.

Event Description

It was reported on (b)(6) 2021, a 33mm epic stented porcine heart valve w/flexfit system.Post procedure, a valve thrombosis was noted in the left and right cavities.The patient was in the intensive care unit (icu) on extracorporeal membrane oxygenation (ecmo).A hemorrhage without heparin induced thrombocytopenia was reported.On (b)(6) 2021, the patient died.Upon autopsy review, it was noted that the patient had a pleural effusion, inferior lateral white myocardial infarction, clots adhered at the tricuspid valve as well left atrium and mitral valve.

Manufacturer Narrative

Explant due to patient death reported.The investigation found that there were no significant pathological changes to the bioprosthetic tissue valve.There was non-adherent focal blood on the inflow surface, likely procedure-related.There was no inflammation, thrombi, or significant calcifications.The device history record was reviewed to ensure each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: EPIC STENTED TISSUE VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13057252
• MDR Text Key: 282603314
• Report Number: 3007113487-2021-00126
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-33M
• Device Catalogue Number: E100-33M
• Device Lot Number: BR00029722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/23/2021; 04/12/2022
• Supplement Dates FDA Received: 01/04/2022; 04/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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; Death