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); Coagulation Disorder (1779); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Renal Failure (2041); Shock (2072); Heart Failure (2206); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 12/01/2016

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 device was not returned for analysis.The lot history record (lhr) and similar complaint review were not performed because the part and lot numbers were not provided.The reported patient effects of cardiac tamponade, respiratory failure, renal failure, shock, cerebrovascular accident, heart failure, coagulopathy, hypertension, myocardial infarction, and cardiogenic shock as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.A conclusive cause for the reported cardiac tamponade, respiratory failure, renal failure, shock, cerebrovascular accident, heart failure, coagulopathy, hypertension, myocardial infarction, and cardiogenic shock cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.Literature title: in-hospital outcomes of percutaneous mitral valve repair in patients with chronic obstructive pulmonary disease: insights from the national inpatient sample database.(b)(4).

Event Description

This is filed to report adverse events excluding death.It was reported through a research article identifying the mitraclip device that may be related to the following: patient deaths, myocardial infarction, tamponade, cardiogenic shock, respiratory failure, renal failure, septic shock, stroke, heart failure, coagulopathy, hypertension, medication, intubation, blood transfusion and prolonged hospitalization.Details are listed in the attached article, titled ¿in-hospital outcomes of percutaneous mitral valve repair in patients with chronic obstructive pulmonary disease: insights from the national inpatient sample database.¿.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Article attached: ¿in-hospital outcomes of percutaneous mitral valve repair in patients with chronic obstructive pulmonary disease: insights from the national inpatient sample database.¿.Attachment: [cn-032847 article.Pdf].

• 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: 10126084
• MDR Text Key: 194306910
• Report Number: 2024168-2020-04780
• 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: 05/18/2020
• Initial Date FDA Received: 06/05/2020
• 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
• Patient Age: 76 YR