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 Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Myocardial Infarction (1969); Sepsis (2067); Tissue Damage (2104); Ventricular Tachycardia (2132); Heart Failure (2206); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 03/01/2009

Event Type  Injury  

Manufacturer Narrative

Event estimated dates.The udi is unknown as the part and lot number is not provided.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, a definitive cause for the reported patient effect of sepsis, mitral stenosis, respiratory failure, ventricular tachycardia, hemorrhage, heart failure, cardiogenic shock, myocardial infarction, recurrent mitral regurgitation, worsening mitral regurgitation, mitral stenosis, and tissue damage cannot be determined.The patient effects of sepsis, mitral stenosis, respiratory failure, ventricular, hemorrhage, heart failure, cardiogenic shock, myocardial infarction, recurrent mitral regurgitation, worsening mitral regurgitation, mitral stenosis, and tissue damage, 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; therefore, no product-related corrective action will be implemented in this case.Literature attachment: predictors for efficacy of percutaneous mitral valve repair using the mitraclip system: the results of the mitraswiss registry.

Event Description

This is filed to sepsis, mitral stenosis, respiratory failure, ventricular tachycardia, hemorrhage, heart failure, cardiogenic shock, myocardial infarction, recurrent mitral regurgitation, worsening mitral regurgitation, mitral stenosis, tissue damage, surgical intervention, medical intervention, prolonged hospitalization.It was reported through a research article identifying mitraclip devices that may be related to: single leaflet device attachment/slda, ruptured delivery catheter [break], sepsis, mitral stenosis, respiratory failure, ventricular tachycardia, hemorrhage, heart failure, cardiogenic shock, myocardial infarction, recurrent mitral regurgitation, worsening mitral regurgitation, mitral stenosis, tissue damage, surgical intervention, medical intervention, and prolonged hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article, titled, "predictors for efficacy of percutaneous mitral valve repair using the mitraclip system: the results of the mitraswiss registry¿.No additional information was provided.

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: 9996991
• MDR Text Key: 189839794
• Report Number: 2024168-2020-03892
• 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: 07/30/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability