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

Catalog Number UNK CDS

Device Problem Off-Label Use (1494)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 01/01/2017

Event Type  Injury  

Event Description

The article role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair, clinical research in cardiology was reviewed.The article presented a prospective single center study to evaluate the role of right ventricular remodeling (rvr) on transcatheter tricuspid valve repair (ttvr) outcomes.Devices mentioned include mitraclip and triclip.The article concluded that ttvr was associated with significant quality of life improvement after one month, irrespective of rvr.Despite increased mortality and rehospitalization for heart failure, ttvr in the presence of rvr still provides substantial symptomatic benefit for patients with severe tr.[ the primary author was marc-andré ehrenfels, university hospital cologne, cologne, germany.The corresponding author was christos iliadis, university hospital cologne, cologne, germany with the corresponding email christos.Iliadis@uk-koeln.De] the time frame of the study was january 2017 and october 2020.A total of 223 patients were included in this study, of which 60 patients received an abbott device (11 mitraclip, 49 triclip).The average age of the patients enrolled was 80.The majority gender was female.As this is from a literature review, patient weight was not provided.Comorbidities included: kidney disease, elevated bilirubin, heart failure, peripheral edema, ascites, tricuspid regurgitation, right ventricle dysfunction, hepatic systolic flow reversal, coronary artery disease, previous coronary artery bypass graft, hypertension, pulmonary hypertension, diabetes mellitus, chronic pulmonary obstructive disease, peripheral artery disease, dialysis, atrial fibrillation, myocardial infarction, stroke, heart surgery, valvular intervention, heart failure medication, pacemaker.(b)(6) mitraclip: peri and post-procedural complications included heart failure, hospitalization, unexpected medical intervention, recurrent tricuspid regurgitation, and off label use.(b)(6) triclip: peri and post-procedural complications included heart failure, hospitalization, unexpected medical intervention, and recurrent tricuspid regurgitation.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number (b)(4).Attachment: article titled ¿ role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair, clinical research in cardiology.".

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, and due to the limited information available (article based on multiple individuals with no specific information), a cause for the reported heart failure/congestive heart failure and tricuspid valve insufficiency/regurgitation (tr) cannot be determined.The reported off-label use of the device was associated with the mitraclip device being used on the tricuspid valve (tv) to treat tricuspid regurgitation (tr).Heart failure is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment: article title: role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair, clinical research in cardiology.

• 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: 18990135
• MDR Text Key: 338772481
• Report Number: 2135147-2024-01368
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/06/2024
• 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