MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Catalog Number CDS0502

Device Problems Positioning Failure (1158); Leak/Splash (1354)

Patient Problems Pulmonary Embolism (1498); Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the mitraclip delivery system air leak.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with an mr grade of 2.The steerable guide catheter and the mitraclip delivery system (cds), were advanced.The leaflets could not be grasped due to the anatomy.The water level in the delivery catheter (dc) handle dropped, and air was observed in the cds.An attempt to remove the air from the device was made.The dc handle was filled with heparinized saline, dripping speed was increased and the red cap was loosened, but air bubbles were confirmed in the left ventricle and ascending aorta.Two-three minutes later, st changes were noted on the electrocardiogram, suggesting an air embolism.A pigtail catheter was advanced from the femoral artery and the air was aspirated from the patient.Medication was administered to dilate the vein and coronary artery.Coronary angiography (cag) was performed.St elevation recovered thirty minutes later.The decision was made to discontinue the procedure.While under general anesthesia, no dilation of the pupil or changes in the blood flow waveform of the head were observed.Hospitalization was prolonged for observation.No clips were implanted, mr remains at 2.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of air embolism, pulmonary embolism, ekg/ecg changes and hypotension, as listed in the mitraclip nt system japan instructions for use (ifu), are known possible complications associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the reported leak.The inability to grasp was due to patient anatomy.The air embolism, ekg/ecg changes and hypotension were due to the procedural conditions of the leaks.The pulmonary embolism is a cascading effect of the air embolism.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the patients blood pressure dropped to 40mmhg.As of (b)(6)2020, there was no patient complication, no neurological finding, the level of consciousness is clear.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10428615
• MDR Text Key: 203729095
• Report Number: 2024168-2020-06938
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00403U188
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 46