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 Inflammation (1932); Mitral Regurgitation (1964)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Event dates estimated.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.The reported patient effects of inflammation and mitral regurgitation as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.Literature attached: mitral valve surgery after mitraclip implantation: what histopathology can tell us? no additional information was provided.

Event Description

This is being filed to report the recurrent mr and inflammation requiring surgical intervention.It was reported through a research article identifying mitraclip that maybe related to the following: mitral regurgitation, inflammation, surgical procedure, and hospitalization.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr).Two clips were implanted with good post-interventional results.One year post implant, severe residual mr was noted therefore the patient was sent for surgical removal of the mitraclips devices.Upon examination, the mitraclip devices were intact however significant inflammatory reactions were seen in the surrounding tissue.Details are listed in the attached article titled: mitral valve surgery after mitraclip implantation: what histopathology can tell us? no additional information was provided.

Manufacturer Narrative

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

• 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: 9897006
• MDR Text Key: 188561104
• Report Number: 2024168-2020-03063
• 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: 07/27/2020

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: 03/10/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 ADDITIONAL IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR