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 Pulmonary Embolism (1498); Stroke/CVA (1770); Myocardial Infarction (1969); Renal Failure (2041); Tissue Damage (2104); Pericardial Effusion (3271)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant: estimated.The devices were not returned for analysis.A review of the lot history records could not be performed as the part and lot information regarding the complaint devices were not provided.The reported patient effects tissue damage, kidney failure, myocardial infarction, pulmonary embolism, stroke, pericardial effusion are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.A definitive cause for the reported patient effects of tissue damage, kidney failure, myocardial infarction, pulmonary embolism, stroke, pericardial effusion could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Article, titled ¿predictors of short- and long-term outcomes of patients undergoing transcatheter mitral valve edge-to-edge repair.¿ the patient deaths and device issues mentioned are filed under different mfr numbers.

Event Description

This is filed to report serious injury.It was reported through a research article identifying the mitraclip device that may be related to the following: patient deaths, tissue damage, kidney failure, myocardial infarction, pulmonary embolism, stroke, pericardial effusion, mitral valve surgery, and prolonged hospitalization.Device issues include single leaflet device attachment/slda.Details are listed in the article, titled ¿predictors of short- and long-term outcomes of patients undergoing transcatheter mitral valve edge-to-edge repair.¿.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attached article, titled ¿predictors of short- and long-term outcomes of patients undergoing transcatheter mitral valve edge-to-edge repair.¿.

• 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: 10255582
• MDR Text Key: 198303869
• Report Number: 2024168-2020-05644
• 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: 07/24/2020

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: 06/22/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 79 YR
• Patient Weight: 74