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

Catalog Number UNK CDS

Device Problem Off-Label Use (1494)

Patient Problems Stroke/CVA (1770); Tricuspid Valve Stenosis (2113)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.(b)(4).The clips remains in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported through a research article 236 patient underwent a mitraclip procedure to treat tricuspid regurgitation (tr).Within one year of the procedure, multiple patient had stroke and an increase in transpulmonary pressure gradient (tpg).Details are listed in the attached article, titled ¿cardiopulmonary hemodynamic profile predicts mortality after transcatheter tricuspid valve repair in chronic heart failure.¿ no additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record review could not be performed as the part and lot information regarding the complaint devices were not provided.The similar complaint review was not performed because there was no device malfunction reported and this complaint was based on an article review with no device/lot information provided.Based on the information reviewed, a cause for the cerebrovascular accident and tricuspid stenosis cannot be determined.It should be noted that the mitraclip instructions for use (ifu) states that "the mitraclip nt system is intended for reconstruction of the insufficient mitral valve through tissue approximation." as it was reported that the mitraclip device was used on the tricuspid valve, this is considered off-label use of the device; however, it cannot be determined whether the off-label use contributed to the reported patient effect.The patient effect of cerebrovascular accident is listed in the ifu as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11322549
• MDR Text Key: 231632775
• Report Number: 2024168-2021-01151
• 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: 03/16/2021

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: 01/22/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other