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

Catalog Number UNK CDS

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  Death  

Event Description

It was reported through a research article that 298 patients underwent mitral transcatheter edge-to-edge repair (m-teer) from march 2014 to june 2022.Within two years of the procedure, the implanted mitraclip may have caused or contributed to recurrent mitral regurgitation, heart failure hospitalization (hfh), and patient death.Additional information is listed in the attached article, titled ¿prognostic value of right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair.¿.

Manufacturer Narrative

The additional patient effects reported in the articles are captured under a separate medwatch report.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 devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information was not provided.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported heart failure/congestive heart failure, mitral valve insufficiency/regurgitation and death cannot be determined.However, mitral regurgitation, heart failure and death 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.Literature attachment: article title: prognostic value of right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair.

• 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: 19174624
• MDR Text Key: 340950065
• Report Number: 2135147-2024-01822
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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?: No
• 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: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/26/2024
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Female