MAUDE Adverse Event Report: ABBOTT VASCULAR 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); Embolism (1829); Endocarditis (1834); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Renal Failure (2041); Sepsis (2067); Tissue Damage (2104); Heart Failure (2206); Foreign Body In Patient (2687); Pericardial Effusion (3271)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Date of event: dates are estimated.The clip remains in 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.Attachment: article titled "mitral valve surgery following failed mitraclip implantation".

Event Description

This is being filed to report the adverse patient effects.It was reported through a research article identifying mitraclip that may be related to tissue damage, mitral regurgitation, atrial septal defect, mitral stenosis, endocarditis, pericardial effusion, renal failure, sepsis, heart failure, clip embolization, stroke, major bleeding, foreign body in the patient, additional intervention, surgical intervention, and hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article: mitral valve surgery following failed mitraclip implantation.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Additionally, a review of the complaint history could not be performed due to unknown lot information.Causes for tissue damage and mitral regurgitation could not be determined.Embolism and foreign body in patient appear to be due to the complete clip detachment (expulsion).The cause for heart failure and kidney failure could not be determined.The hemorrhage appears to be a result of atrial perforation.The atrial perforation appears due to procedural conditions/user technique.The cause for sepsis could not be determined.The patient effects patient tissue damage, mitral regurgitation (mr), atrial septal defect (asd), mitral stenosis, endocarditis, pericardial effusion, renal failure, sepsis, heart failure, clip embolization, stroke, major bleeding, and foreign body in the patient are listed in ifu as known possible complications associated with mitraclip procedures.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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11229717
• MDR Text Key: 228653326
• Report Number: 2024168-2021-00609
• 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
• Report Date: 03/22/2021

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
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability