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 Endocarditis (1834); Fever (1858); Mitral Regurgitation (1964); Tissue Damage (2104); Weakness (2145)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: dates estimated.Udi number is unknown as the part and lot number were not provided.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report post mitraclip procedure, the patient presented with recurrent mr, tissue damage and endocarditis it was reported through a case study which identifies a woman which had a mitraclip procedure to treat nyha iii - iv.Post interventional procedure the nyha state immediately recovered to nyha i.Residual permissive mitral valve incompetence i-ii was classified as an excellent result after mitraclip procedure.Five weeks later the patient felt weak, had fever and returned to nyha iv again.The echocardiography showed ruptured chordae and adherent material on the clip.No cerebral event has occurred so far.Based on the diagnosis of a mitral valve endocarditis after mitraclip with an acute mitra valve insufficiency urgent surgical procedure was required.The intraoperative findings showed an almost completely destroyed mitral valve.The mitraclip device performed perforation in the annulus of mitral valve and chordae were ruptured.Too little left native valve texture was insufficient for any techniques of mitral valve repair.For that reason there had to be a mitral valve replacement with a biological prosthesis.Perioperative course and 1 year follow-up was reported uneventful.Details are listed in the attached article, mitral valve repair: infective endocarditis after mitralclip.No additional information was provided.

Manufacturer Narrative

Date estimated.The clip remains implanted.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.A definitive cause for the reported patient effect of mitral regurgitation, tissue damage, endocarditis, fever, and weakness could not be determined.The reported patient effects of mitral regurgitation, tissue damage, endocarditis, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

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: 9823943
• MDR Text Key: 184759409
• Report Number: 2024168-2020-02316
• 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: 07/23/2020

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: 02/18/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/03/2020; 07/20/2020
• Supplement Dates FDA Received: 04/17/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability