MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER; CLAMP, VASCULAR

Model Number ICF100

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  Injury  

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.

Event Description

Edwards received notification that an issue was experienced during use of an intraclude device model icf100.As reported, after proper positioning during the case it was observed the intraclude migrated through the aortic valve into the left ventricle.The intraclude was deflated after the mvr when it was noticed the improper placement.As reported, the occlusion was started and it was interrupted with return of cardiac electrical activity, might have happened 45 min.After occlusion.Neither intraclude or aortic valve were damaged.As per medical opinion, the intraclude migrated because of improper tension on the line when deployed, so there was room to mobilise distally toward the valve.All information pertinent to this case was received and documented in the file, as per last follow-up done with the sales rep.No further information could be obtained from the site.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections h6 (component codes, type of investigation, investigation findings, investigation conclusions).Per the instructions for use (ifu), the balloon should be positioned just above the sino-tubular junction and vigilance during the case is required.There are multiple warnings in the ifu regarding possible balloon migration during the case and recommendations on mitigations to prevent migration of the balloon.The vast majority of migrations are easily detected and corrected during mis cases if significant balloon migration is not detected, it may result in damage of the aortic valve leaflets or myocardial ischemia from blockage of the coronary ostia.The root cause of this event was due to procedural/technique related factors.As per medical opinion, the intraclude migrated because of improper tension on the line when deployed, so there was room to mobilize distally toward the valve.Per the surgeon's opinion, the issue was not due to the device.Attempts have been made to obtain product for evaluation.The subject device was not returned for evaluation.The device history record (dhr) could not be reviewed, as the device lot number was not provided.However, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.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.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13026540
• MDR Text Key: 284134866
• Report Number: 2015691-2021-06883
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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 Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening