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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; SIZER, HEART-VALVE, PROSTHESIS
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EDWARDS LIFESCIENCES; SIZER, HEART-VALVE, PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
Additional manufacturer narrative: in this case, it was reported that the sizer might be an inaccurate representation for a 27mm 2800tfx valve.The sizer went through the annulus but the respective valve was not implanted as it was too large.The patient was noted to be doing well post procedure with no issues.However, the event is being reported due to the potential of implanting a wrong size valve.The device has not been returned for evaluation.If returned and evaluated, a supplementary report will be submitted with the findings.The device history record (dhr) was not reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.
 
Event Description
It was reported that a 27mm 2800tfx (2021-08859-01) pericardial aortic valve explanted at implant due to sizing issues.The valve was explanted and the avr was attempted with a 25mm 2800tfx (2021-08859-02) pericardial aortic valve which was also explanted at implant due to sizing issues.The valve was explanted and replaced with a 23mm 2800tfx pericardial valve which seated well with no issues.The patient was noted to be doing well post procedure.There was no allegation of device malfunction or product deficiency against either the explanted 27mm 2800tfx valve or the 25mm 2800tfx valve.Per the surgeon, the 27 (2021-08859-03) and 25 (2021-08859-04) sizers passed through the annulus but the respective valves were too large.
 
Manufacturer Narrative
H3: evaluation summary: customer report of sizing issues was unable to be confirmed.Measurements were taken of returned 27mm sizer per drawing 110415 rev.Ae.All measurements were within specification.Specification a on returned sizer measured at 1.246"; specification is 1.25" +/- 0.01".Specification b on returned sizer measured at 0.4700"; specification is 0.470" +/- 0.005".Specification c on returned sizer measured at 1.0600"; specification is 1.063" +/- 0.005".
 
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Brand Name
NI
Type of Device
SIZER, HEART-VALVE, PROSTHESIS
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
MDR Report Key11986935
MDR Text Key259250257
Report Number2015691-2021-03550
Device Sequence Number1
Product Code DTI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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