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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE
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ABBOTT MEDICAL EPIC¿ VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Catalog Number E100-21A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that on (b)(6) 2022, a 21mm epic aortic valve was selected for implant.During the procedure, when the valve was being implanted, it was discovered that the lobe was broken and a new 21mm epic aortic valve was successfully implanted as a replacement.The healthcare professional does not believe the patient or user experienced adverse health consequences due to the performance of the product.The patient was reported to be in stable condition.No additional information was provided.
 
Manufacturer Narrative
An event of the sewing cuff of the valve being damaged was reported.A returned device assessment could not be performed as the device 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
 
Event Description
It was reported that on (b)(6) 2022, a 21mm epic aortic valve was selected for implant.During the procedure, when the valve was being implanted, it was discovered that the lobe was broken and a new 21mm epic aortic valve was successfully implanted as a replacement.The healthcare professional does not believe the patient or user experienced adverse health consequences due to the performance of the product.The patient was reported to be in stable condition.
 
Manufacturer Narrative
An event of the sewing cuff of the valve being damaged was reported.The valve was returned to abbott for investigation and it was found that the valve appeared dehydrated.All three leaflets had limited mobility when manually manipulated and were translucent.No tears or perforations were observed in the cuff or leaflet tissue.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 potential cause of the reported incident could not be conclusively determined.
 
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Brand Name
EPIC¿ VALVE (AORTIC)
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL #3014918977
edificio #44 calle 0, ave. 2
el coyol alajuela 1897- 4050
CS   1897-4050
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key16230452
MDR Text Key308499076
Report Number2135147-2023-00261
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 08/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2023
Device Catalogue NumberE100-21A
Device Lot NumberBR00019806
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2019
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;
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