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); Endocarditis (1834); Hemorrhage/Bleeding (1888); Respiratory Distress (2045); Shock (2072); Cardiac Tamponade (2226); Cardiogenic Shock (2262); No Code Available (3191); Pericardial Effusion (3271)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Dates estimated.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature attachment.Article title¿ transcatheter mitral valve repair in patients with chronic liver disease: insights from the national inpatient sample".

Event Description

This is being filed to report the cardiogenic shock, post procedure respiratory problems, stroke, blood transfusion, endocarditis, cpr, gastrointestinal bleeding, mechanical ventilation, pneumonia, septic shock, cardiac tamponade, pericardiocentesis, and pericardial effusion.It was reported through a research article identifying mitraclip that may be related to patient cardiogenic shock, post procedure respiratory problems, stroke, blood transfusion, endocarditis, cpr, gastrointestinal bleeding, mechanical ventilation, pneumonia, septic shock, cardiac tamponade, pericardiocentesis, and pericardial effusion.Specific patient information is documented as unknown.Details are listed in the attached article: transcatheter mitral valve repair in patients with chronic liver disease: insights from the national inpatient sample.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 as lot and part number was not provided.Based on the information available, a definitive cause for the reported patient effects could not be determined.However the patient effects of cardiogenic shock, cerebrovascular accident (stroke), endocarditis, hemorrhage, shock, cardiac tamponade, and pericardial effusion are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 10515103
• MDR Text Key: 206343736
• Report Number: 2024168-2020-07541
• 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: 11/09/2020

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: 08/20/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability