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 Stroke/CVA (1770); Endocarditis (1834); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Renal Failure (2041)

Event Date 03/14/2019

Event Type  Injury  

Event Description

The article "the coapt secondary mr post-approval study annual progress report 2024" was reviewed.The article presented a prospective multi-center study, to evaluate real-world surveillance to confirm the long-term safety and effectiveness of the mitraclip system in heart failure patients with secondary mitral regurgitation.Devices mentioned include mitraclip.The article concluded that the outcomes from the study so far are as expected from this elderly population with high proportion of comorbidities and are consistent with other mitraclip studies.No new safety risks have been observed during this study.[the primary author and corresponding author was janani aiyer, clinical scientist, clinical affairs, abbott structural heart, with corresponding email (b)(4).] the time frame of the study was 14 march 2019 to 9 may 2023.Say not confirmed or reported if applicable.A total of 5000 patients were included in this study, of which all received an abbott device.Long term data (over 12 months) was available in 2396 of the 5000 patients.The average age of the patients enrolled was 76.The majority gender was male.Average weight was 78 kg.Comorbidities included: heart failure, prior myocardial infarction, angina, ischemic cardiomyopathy, cardiogenic shock, cardiac arrest, porcelain aorta, atrial fibrillation, infective endocarditis, heart failure hospitalization, permanent pacemaker, prior percutaneous intervention, prior coronary artery bypass graft, prior aortic valve repair/replacement, prior mitral repair/replacement, prior tricuspid repair/replacement, prior stroke, transient ischemic attack, carotid stenosis, peripheral arterial disease, current smoker, hypertension, diabetes mellitus, dialysis, chronic lung disease, supplemental oxygen, hostile chest, immunocompromise, aortic regurgitation, functional/degenerative/mixed mitral regurgitation, mitral stenosis, mitral leaflet calcification, leaflet tethering, mitral annular calcification.Peri and post-procedural complications included death, hospitalization, stroke, mitral valve re-intervention, endocarditis, myocardial infarction, mitral valve stenosis, left ventricular assist device (lvad), renal failure, surgical reintervention.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information attachment: coapt report.

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 cerebrovascular accident/stroke, myocardial infarction, renal failure, mitral stenosis, endocarditis and death cannot be determined.However, myocardial infarction (mi), cerebrovascular accident/stroke, renal failure, endocarditis, mitral stenosis and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical interventions, surgical intervention and hospitalization were 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 "the coapt secondary mr post-approval study annual progress report 2024".

• 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: 18921655
• MDR Text Key: 337872813
• Report Number: 2135147-2024-01179
• 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: Other
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• 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): Other; Death