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

Catalog Number CDS0702-XT

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

Patient Problems High Blood Pressure/ Hypertension (1908); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 09/26/2023

Event Type  Injury  

Event Description

This is filed to report tissue damage.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ and an enlarged atrium.It was noted a mitraclip was previously implanted, requiring an additional procedure due to tissue damage and recurrent mr.An xt clip was inserted and successfully deployed.A second nt clip was then inserted.However, while positioning the nt clip, it was observed the xt clip caused damage to the anterior leaflet and the patient¿s blood pressure increased.Therefore, the physician decided to remove the nt clip, and the procedure was discontinued.Mr remained at a grade of 4+.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The clip remains in the 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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information provided the reported unspecified tissue injury associated with anterior leaflet damage resulting in unchanged mitral valve insufficiency/ regurgitation (mr) and hypertension is related to patient and procedural conditions and due to the clip causing damage due to fragility of the leaflets.Hypertension, tissue damage and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Serious injury/ illness/ impairment was a result 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 (MDD)
• 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: 17950010
• MDR Text Key: 325899533
• Report Number: 2135147-2023-04556
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/15/2023

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: 06/03/2024
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 30605R1068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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: CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other