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Model Number ICF100
Device Problems Burst Container or Vessel (1074); Material Rupture (1546)
Patient Problems Death (1802); Hypoxia (1918)
Event Date 03/15/2019
Event Type  Death  
Manufacturer Narrative
Evaluation summary: the device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the balloon was observed to be ruptured.Edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Engineering task has been opened and assigned for further investigation.Additional manufacturer narrative: the clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the balloon bursts during a procedure, the heart would fill and warm, the operative site may be obscured and the procedure may need to convert to an open procedure.In this case, the balloon ruptured and possibly lead to a prolonged or time.The device was evaluated and the report of "balloon burst" was confirmed.An engineering evaluation has been opened for further investigation.A supplemental report will be submitted upon completion.
Event Description
Edwards received notification that during a totally endoscopic coronary artery bypass (tecab) surgery using an intra-aortic occlusion catheter device, there was a balloon burst.The medical team is very experience with the use of the device (approx.38 cases in tecab with intra-aortic occlusion catheter ).As reported, the balloon bursted during the anastomosis of the vessel lima to riva so there was no possibility to accidentally stitched the balloon in the aorta during that process.The team was able to remove the ruptured intra-aortic occlusion catheter device and replace it with a second one so they was able to finish the operation.The patient died approximately 10 days after surgery with the estimated diagnosis of hypoxic brain damage.As reported it was no clear if the prolonged or time/balloon burst is responsible for this event.As per perfusion report, the total cpb time was 4 hours 50 min and aorta clamp time was 2 hours 6min.
Event Description
Edwards received notification that during a totally endoscopic coronary artery bypass (tecab) surgery using an intra-aortic occlusion catheter, there was a balloon burst.As explained by the surgeon, about 30 minutes after going on pump and intra-aortic occlusion catheter balloon placement/inflation and while preparation of coronary, a balloon pressure drop was noticed.Until that moment, balloon pressures were around 300 mmhg having to add few milliliters of saline (4-5 ml in total) to maintain balloon pressure.Overall volume for the balloon did not exceed ifus instructions.Patient has an aorta size was 3.8 and there were no calcifications.The balloon burst during the anastomosis of the vessel lima to riva so there was no possibility to accidentally stitched the balloon in the aorta during that process.After rupture, the balloon was exchanged and the procedure continued.The cabg could be successfully completed although with long cpb time.As per perfusion report, total cpb time was 4h 50 min and aorta clamp time was 2h 6min.The patient was transferred to icu.The next day sedation was stopped before planned extubation; however patient did not wake up and seizures occurred.Mri scan revealed massive hypoxic brain damage on both hemispheres (multiple cerebral infarcts).The surgeon noted that during surgery, the cerebral vigilance monitoring showed a drop after the balloon rupture but values were always above normal oxygenation.After brain death confirmation, therapy was stopped.The patient passed away approximately on pod+10.This was a low risk patient with no relevant comorbidities.As per surgeon´s opinion, this death is potentially device related due to the detrimental effect of the long cbp and clamping time.In tecab surgeries, when balloon rupture occurred there is a positive root pressure with antegrade flow of cardioplegia into aorta and upper branches that could partially interferes with oxygenated blood perfusion of cerebral arteries.The surgeon and the medical team are very experienced with the use of the device (approx.38 cases in tecab with icf100; 400 intra-aortic occlusion catheter cases so far).Normal icf procedure includes: initial balloon volumen 20ml, then adding additional volumen until device does not move.Target balloon pressure 350 mmhg.
Manufacturer Narrative
Updated event description per additional information received.
Manufacturer Narrative
Edwards received additional information through follow up that the pathological examination confirmed the diagnosis of a diffuse hypoxic encephalopathy and found no evidence of electrolyte fluctuation-induced changes.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.An engineering evaluation was performed and a supplier manufacturing defect was confirmed.A design, ifu, and labeling defect were not confirmed.The trend was reviewed and found to be in control.A clinical root cause cannot be determined as the damage was sustained during the procedure and handling was not reported.The root cause investigation is on-going and will be investigated as part of a capa.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.
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
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Brand Name
Type of Device
Manufacturer (Section D)
one edwards way
irvine CA 92614
MDR Report Key8556944
MDR Text Key143317157
Report Number3008500478-2019-00128
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61713218
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Required Intervention;
Patient Age73 YR
Patient Weight95