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 Problems High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

The additional patient effect of death reported in the article is 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.

Event Description

It was reported through a research article that 239 patients underwent transcatheter edge-to-edge repair of the mitral valve (m-teer) from (b)(6) 2010 and (b)(6) 2016.Follow up was performed within six months of the procedure.The results showed that the implanted mitraclips may have caused or contributed to recurrent mitral regurgitation (mr), pulmonary hypertension, heart failure (hf) requiring hospitalization, and death.Additional information is listed in the attached article, titled ¿impact of pulmonary hypertension on outcomes after teer in patients suffering from mitral regurgitation.¿.

Manufacturer Narrative

The additional patient effect of death reported in the article is captured under a separate medwatch report.D4 - the udi number is not known as the part and lot numbers were not provided.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 hypertension, mitral valve insufficiency/regurgitation (mr), heart failure/congestive heart failure and death cannot be determined.However, hypertension, mitral regurgitation (mr), 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.

• 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: 19175783
• MDR Text Key: 340966048
• Report Number: 2135147-2024-01826
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 04/29/2024
• Supplement Dates FDA Received: 05/16/2024
• 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): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female