MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Convulsion/Seizure (4406)

Event Date 04/18/2022

Event Type  Injury  

Event Description

This is filed for air in the patient anatomy, with adverse patient effects and requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The patient anatomy included a posterior prolapse and anterior flail.The clip delivery system (cds) was advanced into the anatomy, and it was noted that the stopcock was closed to the device.When the stopcock was opened, air entered the patient anatomy.The device was removed from the anatomy.Aspiration was performed to remove the air; however, the patient experienced st elevation, decreased blood pressure and decreased heart rate.Medications were administered to stabilize the patient.The procedure continued with use of a second cds.One clip was implanted and the mr was reduced from grade 4 to grade 1+.Post procedure, the patient was transferred to the intensive care unit (icu).While in icu, the patient experienced a seizure, reported to be related to the air that entered the anatomy.The patient experienced weakness on the left side.Magnetic resonance imaging (mri) and computerized tomography (ct) were performed and the results were negative for stroke.The patient was intubated.The weakness resolved.The patient is in stable condition at this time and has been discharged to home.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned and investigated.The reported improper or incorrect procedure or method (failure to follow instructions) could not be tested via returned device analysis as it was associated with user error.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 identified no similar complaints reported from this lot.The reported patient effects of air embolism, ekg/ecg changes, hypotension, bradycardia, seizure, and fatigue, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.It should be noted that per the eifu, mitraclip system gen 4, u.S.Warns ¿heparinized saline flush should be continuous throughout the procedure.Discontinuing flush may result in air embolism and/or thrombus formation.Confirm that the stopcock on the clip introducer flush port is closed and that the clip introducer is de-aired.In this case, it was reported that the user opened the stopcock during the procedure which resulted in air entering the patient anatomy.This is a deviation from the ifu.The investigation determined the reported improper or incorrect procedure or method (failure to follow instructions) was due to the user error of opening the stopcock during the procedure.The reported air embolism was due to the user error of opening the stopcock during the procedure as it was reported that when the stopcock was opened, air entered the patient anatomy.The ekg/ecg changes, hypotension, bradycardia, seizure, and fatigue appear to be cascading effects of the air embolism.The reported unexpected medical interventions and medication required were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14324020
• MDR Text Key: 291207682
• Report Number: 2024168-2022-04993
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 11014R463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 63 KG