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

Catalog Number UNK CDS

Device Problem Off-Label Use (1494)

Patient Problem Tricuspid Valve Stenosis (2113)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.(udi#): in the absence of a reported part number, the udi cannot be calculated.(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article titled, "percutaneous mitral valve repair in adults with congenital heart disease: report of the first case-series".

Event Description

This is filed to report mitral stenosis.It was reported in an article review, that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4.It was noted a very small posterior leaflet.Two xtr clips were successfully deployed for off-label use reducing tr.However, the mean pressure gradient increased to 5mmhg.Additional treatment was not performed.Both clips are stable.Two clips were implanted, reducing tr to 1.There was no reported clinically significant delay in the procedure.A four month follow-up revealed the heart function classification has improved.No additional information was provided.

Manufacturer Narrative

Udi is unknown as the part and lot number were not provided.The device was not returned.The lot history record (lhr) review and similar complaint review was not performed because this incident was based on an article review and no device/lot information was provided, based on available information, the cause for the reported tricuspid stenosis could not be determined.It was reported that the procedure was used to treat tricuspid regurgitation.It should be noted that the intended use section of the mitraclip system, instruction for use states: ¿the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation¿.The device was used for a tricuspid valve procedure; therefore, this is considered as an off-label use of the device.It could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10607564
• MDR Text Key: 209203094
• Report Number: 2024168-2020-08135
• 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: 11/14/2020

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: 09/14/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 59 YR