MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Embolism (1829); Endocarditis (1834); Fever (1858); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Ischemia (1942); Mitral Regurgitation (1964); Renal Failure (2041); Heart Failure (2206)

Event Date 03/17/2018

Event Type  Injury  

Manufacturer Narrative

The clip remain in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional patient effects reported are being filed under a separate mfr number.Attachment: article titled, infective endocarditis following transcatheter edge-to-edge mitral valve repair: a systematic review.

Event Description

This is filed to report fever, dyspnea, hypotension, infection, heart failure, embolism, endocarditis, increased mitral regurgitation (mr), hemorrhage, renal failure and ischemia.It was reported through a summary article identifying a mitraclip procedure that may be related to the following: fever, dyspnea, hypotension, infection, heart failure, embolism, endocarditis, increased mitral regurgitation (mr), hemorrhage, renal failure, ischemia, treatment with medication, medical intervention, hospitalization, surgical intervention and death.Details are listed in the attached article, titled: infective endocarditis following transcatheter edge-to-edge mitral valve repair: a systematic review.

Manufacturer Narrative

B3: date estimated.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 conclusive cause for the reported patient effects of fever, dyspnea, hypotension, infection, heart failure, embolism, endocarditis, increased mitral regurgitation (mr), hemorrhage, renal failure, ischemia, and the relationship to the device, if any, cannot be determined.Patient effects of fever, dyspnea, hypotension, infection, heart failure, embolism, endocarditis, increased mitral regurgitation (mr), hemorrhage, renal failure, ischemia, treatment with medication, medical intervention, hospitalization and surgical intervention as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Attachment: article titled, infective endocarditis following transcatheter edge-to-edge mitral valve repair: a systematic reviewna - attachment: [infective endocarditis following transcatheter edge-to-edge.Pdf].

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9631843
• MDR Text Key: 176555046
• Report Number: 2024168-2020-00897
• 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,Followup
• Report Date: 07/28/2020

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: 01/09/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/27/2020; 07/20/2020
• Supplement Dates FDA Received: 02/04/2020; 07/28/2020
• 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