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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-PLYMOUTH) EPIC STENTED TISSUE VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL (CVD-PLYMOUTH) EPIC STENTED TISSUE VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number CVD0028
Device Problems Material Puncture/Hole (1504); Incomplete Coaptation (2507)
Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)
Event Date 01/25/2022
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported that an unknown sized epic stented tissue valve was implanted in a mitral position on unknown date.On an unknown date, regurgitation was confirmed by an echocardiography.Redo mvr was conducted on (b)(6) 2022.The epic valve was explanted and unknown valve was implanted instead.Perforation was confirmed on the epic leaflets corresponding leaflet location for p2 to p3 and p3, and the posterior leaflet remained open position which caused regurgitation.Patient stable, no additional information was provided.
 
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported that an unknown sized epic stented tissue valve was implanted in a mitral position on unknown date.On an unknown date, regurgitation was confirmed by an echocardiography.Redo mvr was conducted on (b)(6) 2022.The epic valve was explanted and unknown valve was implanted instead.Perforation was confirmed on the epic leaflets corresponding leaflet location for p2 to p3 and p3, and the posterior leaflet remained open position which caused regurgitation.Patient stable, no additional information was provided.
 
Manufacturer Narrative
Additional information sections: d9, h2, h3, h6, h10.Explant due to regurgitation reported.The investigation found that all three cusps were torn.All three cusps had marked thinning and loss of collagen fibers at the cusp base.No acute inflammation or significant calcifications were present.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear sites, which could have contributed to the formation of the tear.
 
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Brand Name
EPIC STENTED TISSUE VALVE (UNKNOWN)
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST. JUDE MEDICAL (CVD-PLYMOUTH)
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL (CVD-PLYMOUTH)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key13554571
MDR Text Key285815079
Report Number3005334138-2022-00089
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P040021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCVD0028
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2022
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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