• 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 INTRACLUDE CLAMP, VASCULAR

  • 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 INTRACLUDE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Noise, Audible (3273)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Event Date 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to edwards for evaluation. A definitive root cause could not be determined. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
 
Event Description
Edwards received notification that the balloon of this intraclude device burst during a minimal invasive mitral valve replacement redo-surgery. The event occurred during removal of the failing perimount valve, and before stitching the sutures. There was no loss of balloon pressure before the rupture, the surgeon just heard the noise. At the moment of the burst there was no manipulation on the annulus. Volumen used to inflate the balloon is usually 40-50 ml (until pressure is above 300 mmhg, normally between 300-350 mmhg). They only give extra volumen (1 to 3ml) if the pressure goes down to 280 mmhg which did not occurred in this case. Preoperative examinations of patient´s aorta showed normal size (3. 2-3. 4mm) with little plaques, not relevant. After balloon burst, the surgeon was able to finish the case with the use of a chitwood clamp. A non-edwards mitral valve was implanted in the patient. After finishing the case in the icu, patient blood pressure dropped down and the team performed heavy manual reanimation. A bleeding was suspected and they opened the chest via sternotomy. There was a rupture of the left ventricle. As reported, ventricle rupture could have been due to heavy reanimation manuevres. The patient died in icu few hours after surgery. As per surgeon´s opinion, patient's death has nothing to do with the icf100 balloon rupture and it was a combination of high risk surgery in a redo case of a (b)(6) year-old with fragile heart structure and the need of having to use fibrinous hemostyptic for stopping bleeding of the atrium in a fragile heart structure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRACLUDE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
mle2
irvine, CA 92614
9492502289
MDR Report Key8772164
MDR Text Key150718004
Report Number3008500478-2019-00149
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2021
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61898938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-