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

Catalog Number CDS0702-XT

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Endocarditis (1834); Fatigue (1849); Fever (1858); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 3 and flail.Two clips were implanted, reducing mr to a grade of 1.On (b)(6) 2024, the patient returned to the hospital due to dyspnea.On (b)(6) 2024, imagining showed that one of the implanted clips had detached from anterior leaflet and remained attached to the posterior (single leaflet device attachment/slda), causing mr to increase to 4.It was also observed endocarditis growth on both implanted mitraclips.The patient was experiencing fatigue and had a fever due to the endocarditis.Iv antibiotics were given to the patient to treatment.

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.

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 identified no similar complaints reported from this lot.Based on available information, the cause of the reported slda and endocarditis were unable to be determined.The reported worsening mr was a cascading event of the reported slda.The reported dyspnea was a cascading event of the reported worsening mr.The reported fatigue and fever were cascading effects of the reported endocarditis.The reported patient effects of dyspnea, endocarditis, fever, and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and medication required were results 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 (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: 18970367
• MDR Text Key: 338506498
• Report Number: 2135147-2024-01328
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230998
• UDI-Public: (01)08717648230998(17)240710(10)30712R1065
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 04/30/2024

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 Catalogue Number: CDS0702-XT
• Device Lot Number: 30712R1065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male