MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP 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); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Tissue Damage (2104); Ventricular Tachycardia (2132); Cardiac Tamponade (2226)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Estimated dates.As this is from a literature review, the device will not be returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional adverse patient effect of death and the device malfunction referenced are being filed under separate medwatch reports.¿left ventricular end-systolic dimension and outcome in patients with heart failure undergoing percutaneous mitraclip valve repair for secondary mitral regurgitation.¿.

Event Description

This is filed to report recurrent mitral regurgitation, mitral stenosis, myocardial infarction, tissue damage, cardiac tamponade, heart failure, hemorrhage, stroke,ventricular tachycardia, medical intervention, surgical intervention, and prolonged hospitalization.It was reported through a research article identifying mitraclip devices that may be related to the following: single leaflet device attachment/slda, difficult to deploy, recurrent mitral regurgitation, mitral stenosis, myocardial infarction, tissue damage, cardiac tamponade, heart failure, hemorrhage, stroke,ventricular tachycardia, medical intervention, surgical intervention, prolonged hospitalization and death.Specific patient information is documented as unknown.Details are listed in the attached article, titled, "left ventricular end-systolic dimension and outcome in patients with heart failure undergoing percutaneous mitraclip valve repair for secondary mitral regurgitation." no additional information was provided.

Manufacturer Narrative

Dates estimated.The udi is unknown as the part and lot number were not provided.The devices were not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint devices were not provided.Based upon the information reviewed, the mitraclip device likely contributed to the patient effects of mr, mitral stenosis, myocardial infarction, mitral valve injury (tissue damage), cardiac tamponade, hemorrhage, cerebrovascular accident, and ventricular tachycardia however it could not be determined.The reported patient effects of mitral regurgitation (mr), mitral stenosis, myocardial infarction, mitral valve injury (tissue damage), cardiac tamponade, hemorrhage, cerebrovascular accident, ventricular tachycardia as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9986364
• MDR Text Key: 188553113
• Report Number: 2024168-2020-03822
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

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
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 07/20/2020
• Supplement Dates FDA Received: 05/11/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability