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

Catalog Number CDS0705-XT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report an air embolus that resulted in a cascade of effects.It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr), prolapsed posterior leaflet, lateral p2 flail, and annular dilatation.During a mitraclip procedure, the second clip, an xt, was placed medial to the first clip on a2/p2.The heparinized flush was increased as the lock line was pulled, when an air embolus was observed moving from the left atrium to the left ventricle.It was suspected to have come from the tubing or the clip delivery system (cds), as it was noted once the flush increased.There was no air noticed in the tubing, device, or steerable guide catheter (sgc) chamber.Additionally, the patient had st elevation and depressed right ventricular function (heart failure).Deployment was paused, and phenylephrine and ephedrine were administered to increase the blood pressure and flush out the air embolus.The patient was then stable and deployment was completed.The mr was reduced to grade 1.There was no adverse patient sequelae or clinically significant delay.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.Based on available information and without the device to analyze, the reported heart failure/congestive heart failure (treatment with medication(s)) associated with the depressed rv function, and the reported ekg/ecg changes (treatment with medication(s)) associated with the st elevation, appear to be due to the air embolism.The cause of the reported air embolism (therapy/non-surgical treatment, additional) associated with the air bubble in the la and lv could not be determined.The reported patient effects of embolism, ekg/ecg changes (cardiac arrhythmias), and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality 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 MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16911052
• MDR Text Key: 314996669
• Report Number: 2135147-2023-02048
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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 Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Catalogue Number: CDS0705-XT
• Device Lot Number: 21115R1092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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
• Treatment: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White