• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number 11500A21
Device Problem Gradient Increase (1270)
Patient Problems Bradycardia (1751); Insufficient Information (4580)
Event Date 07/05/2023
Event Type  Injury  
Event Description
It was reported that a patient with a 21mm 11500a insipiris valve was scheduled for a tavr procedure after an implant duration of two (2) years, nine (9) months due to severe aortic stenosis.It was then noted that the patient was too sick to proceed with the tavr per the physician team.Upon induction of anesthesia, the patient experienced a bradycardic arrest with profound hypotension and hypoxia requiring cpr.The patient had ongoing respiratory failure, bradycardia, and cardiac arrest and later expired with an unspecified cause of death.There was no allegation by the physicians that the 21mm 11500a inspiris valve caused or contributed to the patient's death.
 
Manufacturer Narrative
H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
 
Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including coronary artery disease (cad), coronary artery bypass graft (cabg) and end stage kidney disease (esrd) on dialysis.
 
Event Description
It was reported that a patient with a 21mm 11500a inspiris aortic valve underwent an attempted tavr procedure after an implant duration of approximately 2 years and 9 months due to stenosis.Upon induction of anesthesia, the patient experienced a bradycardic arrest requiring cpr.The procedure was aborted.It was later learned the patient expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSPIRIS RESILIA AORTIC VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
saurav singh
1 edwards way
irvine, CA 92614
9492506615
MDR Report Key17417903
MDR Text Key320021384
Report Number2015691-2023-14893
Device Sequence Number1
Product Code LWR
UDI-Device Identifier00690103194975
UDI-Public(01)00690103194975(17)250218(11)200220216457145
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 09/15/2023
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? No
Device Model Number11500A21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/05/2023
Initial Date FDA Received07/28/2023
Supplement Dates Manufacturer Received07/20/2023
09/07/2023
Supplement Dates FDA Received08/14/2023
09/15/2023
Date Device Manufactured02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other; Life Threatening; Hospitalization;
Patient Age71 YR
Patient SexFemale
-
-