MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

Model Number	ICF100
Health Effect - Clinical Codes	Unspecified Infection (1930); Renal Failure (2041); Respiratory Distress (2045); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	06/01/2018
Type of Reportable Event	Death
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, after the balloon rupture, the surgery was finished in cold ventricular fibrillation.As per surgeon´s opinion, the death was probably not related with the device as per patient pre-operative conditions.The device was not returned for evaluation at this time.The root cause of the rupture remains indeterminable.If new information is received, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device lot 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.
Event or Problem Description
Edwards received notification that during a mitral valve replacement (mvr) surgery, the balloon of an intra-aortic occlusion catheter ruptured during use.After balloon rupture, the surgery was finished in cold ventricular fibrillation (bailout strategy).After extubation the patient was transfer to icu where the patient had to be re-intubated due to being adynamic, weak and ran into respiratory insufficiency.Brain damage showed no pathological finding.Patient had nosocomial infection that deteriorated developing renal failure.Patient passed away on pod+5 from multiple organ failure.This high-risk female patient had acute infective endocarditis and was in very critical condition on admission.As per surgeon´s opinion, the death was probably not related with the device as per patient pre-operative conditions.In mvr surgeries, consequences of balloon rupture imply de-airing challenge because low pressure with backflow of cardioplegia into lv through av occur.The surgeon and medical team are very experienced with the device (around 400 cases so far).Normal procedure includes: initial balloon volumen was 20ml, then adding additional volumen until device does not move.Target balloon pressure was 350 mmhg.At the time of this case, patient´s ct scan was not done regularly in all patients (contraindication in case of plaques, calcification) and they were not strict with limiting patients to 40mm aorta size (as per ifu) so it could be a bit bigger.
Additional Manufacturer Narrative
An engineering evaluation was completed and a manufacturing, supplier, design, ifu, and labeling defect were not confirmed.The trend was reviewed and found to be in control.No further action is required.The root cause cannot be determined at this time.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.
Additional Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
• Common Device Name: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8620026
• Report Number: 3008500478-2019-00133
• Device Sequence Number: 2211576
• Product Code: DXC
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 07/23/2020
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/24/2019; 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention