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); Embolism (1829); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Myocardial Infarction (1969); Respiratory Distress (2045); Transient Ischemic Attack (2109); Heart Failure (2206); Foreign Body In Patient (2687); Pericardial Effusion (3271)

Event Date 07/01/2014

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.Implant date: estimated.The devices were not returned for analysis.Exception review and the similar complaint review could not be performed as the part and lot numbers were not provided.The reported patient effects myocardial infarction, stroke, heart failure, reintubation, hemorrhage, blood transfusion, mitral regurgitation, heart failure, transient ischemic attack, respiratory failure, cardiopulmonary resuscitation, embolism, foreign body and pericardial effusion as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a definitive cause for the reported patient effects myocardial infarction, stroke, heart failure, reintubation, hemorrhage, blood transfusion, mitral regurgitation, transient ischemic attack, respiratory failure, cardiopulmonary resuscitation, embolism, foreign body and pericardial effusion could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other patient deaths and device issues referenced are filed under different mfr numbers.

Event Description

This is filed to report serious injuries.It was reported through a research article identifying the mitraclip device that may be related to the following patient effects: patient deaths, myocardial infarction, stroke, heart failure, re-intubation, hemorrhage, blood transfusion, mitral regurgitation, heart failure, transient ischemic attack, re-hospitalization, medical intervention, respiratory failure, cardiopulmonary resuscitation, embolism, foreign body, pericardial effusion and surgical intervention, and the following device issues: single leaflet device attachment (slda).Details are listed in the attached article, titled ¿one-year outcomes and predictors of mortality after mitraclip therapy in contemporary clinical practice: results from the german transcatheter mitral valve interventions registry." please see attached article for additional information.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Article attachment: ¿one-year outcomes and predictors of mortality after mitraclip therapy in contemporary clinical practice: results from the german transcatheter mitral valve interventions registry.

• 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: 10049984
• MDR Text Key: 190753476
• Report Number: 2024168-2020-04263
• 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: foreign,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: 05/12/2020
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 76 YR