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

Model Number ICF100

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 10/18/2021

Event Type  Injury  

Event Description

Edwards received information that it was suspected that a small portion of the intima of the right femoral artery might have been loosened during femoral arterial cannulation with an er23 endoreturn cannula ((b)(4)).The fragment ended up in the ascending aorta, perhaps transported by the icf100 ((b)(4)) or wire introduced through the endoreturn cannula.It then migrated into the left main coronary artery.There was some calcification in the femoral artery that may have provided a platform for the separation of the intimal layer during cannulation.The patient expired later due to unknown reasons.As reported, the event was not due to edwards device malfunction.Additional information received: the surgical procedure was a robotic mitral valve repair/replacement.A sternotomy was performed with cabg x3.An aortotomy was done to recover and remove the section of the femoral artery intima that had been transported from the femoral artery into the ascending aorta either via an additional guidewire (non-edwards) and/or a catheter (including icf100).The femoral artery intima was discovered when the medical team saw the fragment on tee when looking at the ascending aorta.That was confirmed after the aortotomy and exploration of the left main coronary artery, when it was removed.The medical team believed the fragment came from the femoral artery because it was the only arterial access point (except the radial artery monitoring lines), and the caliber of the fragment was the same as the point of introduction of the femoral artery.Calcification in the femoral artery was identified on ct scan (visual and digital inspection) prior to the procedure.However, the impression was that it would not be problematic.There was some difficulty getting the guidewire supplied with the icf100 to advance smoothly.It was estimated that this difficulty was encountered at or just proximal to the aortic bifurcation.In regards to the occlusion of the left main, it was discovered upon exploration of the aortic root.The icf100 was introduced, positioned, but not used.The cause of death was due to an undisclosed clotting disorder that enabled clot to form in much of the vasculature in and around the heart.Anecdotally, the family disclosed a genetic abnormality after all the events.The patient had a history of coagulopathy.

Manufacturer Narrative

It was reported that a small portion of the intimal layer of the right femoral artery might have been detached during femoral arterial cannulation with an endoreturn cannula.Loose fragments in the vasculature have the potential to cause injury by embolization and causing infarction.In this case, the fragment was possibly pushed by a catheter (icf100) or guidewire up to the ascending aorta and ended up in the left main coronary artery.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.The device history record (dhr) was not reviewed as the device lot number was not provided.The subject device is not available to be returned for evaluation as it was discarded.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

Edwards received information that it was suspected that a small portion of the intima of the right femoral artery might have been loosened during femoral arterial cannulation with an er23 endoreturn cannula (2021-18583-01).The fragment ended up in the ascending aorta, perhaps transported by the icf100 (2021-18583-02) or wire introduced through the endoreturn cannula.It then migrated into the left main coronary artery.There was some calcification in the femoral artery that may have provided a platform for the separation of the intimal layer during cannulation.The patient expired later due to unknown reasons.As reported, the event was not due to edwards device malfunction.Additional information received: the surgical procedure was a robotic mitral valve repair/replacement.A sternotomy was performed with cabg x3.An aortotomy was done to recover and remove the section of the femoral artery intima that had been transported from the femoral artery into the ascending aorta either via an additional guidewire (non-edwards) and/or a catheter (including icf100).The femoral artery intima was discovered when the medical team saw the fragment on tee when looking at the ascending aorta.That was confirmed after the aortotomy and exploration of the left main coronary artery, when it was removed.The medical team believed the fragment came from the femoral artery because it was the only arterial access point (except the radial artery monitoring lines), and the caliber of the fragment was the same as the point of introduction of the femoral artery.Calcification in the femoral artery was identified on ct scan (visual and digital inspection) prior to the procedure.However, the impression was that it would not be problematic.There was some difficulty getting the guidewire supplied with the icf100 to advance smoothly.It was estimated that this difficulty was encountered at or just proximal to the aortic bifurcation.In regards to the occlusion of the left main, it was discovered upon exploration of the aortic root.The icf100 was introduced, positioned, but not used.The cause of death was due to an undisclosed clotting disorder that enabled clot to form in much of the vasculature in and around the heart.Anecdotally, the family disclosed a genetic abnormality after all the events.The patient had a history of coagulopathy.

Manufacturer Narrative

It was reported that a small portion of the intimal layer of the right femoral artery might have been detached during femoral arterial cannulation with an endoreturn cannula.Loose fragments in the vasculature have the potential to cause injury by embolization and causing infarction.In this case, the fragment was possibly pushed by a catheter (icf100) or guidewire up to the ascending aorta and ended up in the left main coronary artery.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.The device history record (dhr) was not reviewed as the device lot number was not provided.The subject device is not available to be returned for evaluation as it was discarded.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.

Manufacturer Narrative

The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• 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: 12849198
• MDR Text Key: 285160294
• Report Number: 2015691-2021-06405
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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
• Date Manufacturer Received: 01/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female