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

Catalog Number CDS0705-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 08/03/2023

Event Type  Injury  

Event Description

This will be filed to report incomplete coaptation, recurrent mitral regurgitation, and tissue damage.It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+ with a restricted posterior leaflet and dilated left atrium.Two clips were successfully implanted, and the procedure was concluded with a resulting mr of grade 1+.On (b)(6) 2023 the patient was referred to the hospital for swelling.A transthoracic echocardiogram was performed and it was observed both implanted clips detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda) and chordal rupture occurred.This caused mr to increase to a grade of 4+.No additional information was provided.

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.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and the reported slda appears to be related to patient conditions (tethered posterior leaflet).Unspecified tissue injury, mitral valve insufficiency/ regurgitation (recurrent mr) and swelling/edema appear to be due to the slda.Mitral regurgitation, swelling/edema and tissue injury/damage are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.

• 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: 17617827
• MDR Text Key: 321921781
• Report Number: 2135147-2023-03726
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 08/24/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30502R1097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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: IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic