MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-29M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/03/2021

Event Type  Injury  

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 (b)(6) 2021, a 30mm sjm rigid saddle ring was selected for implant.After the ring was implanted a leak/regurgitation was noted.The ring was explant and replaced with a 29mm epic stented porcine heart valve w/flexfit system on (b)(6) 2021.Post procedure nodal rhythm was noted interspersed with bigeminy was noted and no medical intervention was performed.On (b)(6) 2021, peripheral edema was reported and medication was administrated.On (b)(6) 2021, pleural fluid and a pericardial effusion was noted post surgery and diuretics were given and an acute pericardiocentesis was performed.Low hemoglobin was noted and it was due to a tamponade and the patient received vitamin k and cofact.It is unknown what caused the tamponade.There were not complications noted when implanting the epic valve.The patient was reported to be in stable condition and is recovering.(crd_985 - arb pmcf; eu1671-304; r621324301, r621315201, r621326301, r620360301, r620360501) manufacturer report number: 3007113487-2021-00019.

Manufacturer Narrative

An event of peripheral edema, pericardial effusion and tamponade were reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12365465
• MDR Text Key: 268063126
• Report Number: 3007113487-2021-00020
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-29M
• Device Lot Number: BR00027416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RSAR-30, 19017707; RSAR-30, 19017707
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 81