MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that on an unknown day in (b)(6) 2023, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr).A mitraclip was implanted without issues.On (b)(6) 2024, the patient returned to the hospital with dyspnea.On (b)(6) 2024, the patient returned to the hospital, and an echocardiogram was performed and revealed that the previously implanted clip had detached from the anterior mitral leaflet (aml) and remained attached to the posterior mitral leaflet (pml) (single leaflet device attachment/slda), causing the mr to increase to a grade of 3.An additional mitraclip procedure was performed, and one clip was implanted, reducing mr to a grade of 1-2.

Manufacturer Narrative

B3: date of event is estimated as 03/05/2024.D6a: date of implant is estimated as (b)(6) 2023.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.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review and complaint history review were not performed because no lot information was provided.Based on available information, the cause of the reported slda was unable to be determined.The reported recurrent mr was a cascading event of the reported slda.The reported dyspnea was a cascading event of the reported recurrent mr.The reported patient effects of mitral regurgitation and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention 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® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 19092737
• MDR Text Key: 339982147
• Report Number: 2135147-2024-01662
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/03/2024

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: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization