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

Catalog Number UNK CDS

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Renal Failure (2041); Tricuspid Regurgitation (2112); Ventricular Tachycardia (2132); Heart Failure (2206)

Event Date 10/07/2017

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant ¿ 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 was not provided.Per the mitraclip instructions for use (ifu), the mitraclip system is intended for reconstruction of the insufficient mitral valve.It could not be determined if using the mitraclip on the tricuspid valve caused or contributed to the reported difficulties.The reported patient effects of hemorrhage, cerebrovascular accident, tricuspid regurgitation, renal failure, ventricular tachycardia, heart failure , mitral stenosis, mitral regurgitation as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medical affairs director who concluded, deaths are reported during the follow-up and none seems related to the device as per the available information.Rate of other complications are within the expected ranges in this elderly population.A definitive cause for the reported patient effects of hemorrhage, cerebrovascular accident, tricuspid regurgitation, renal failure, ventricular tachycardia, heart failure , mitral stenosis, mitral regurgitation could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.The deaths and device deficiency mentioned and in the article are filed under separate mfr numbers.Literature attachment: ¿institutional learning experience for combined edge-to-edge tricuspid and mitral valve repair.¿.

Event Description

This is filed to report serious injury.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, difficult visualization, off-label use in the tricuspid valve, mitral regurgitation, tricuspid regurgitation, mitral stenosis, heart failure, hemorrhage, stroke, renal failure, ventricular tachycardia, re-hospitalization, medical intervention, and surgical intervention.Device issues include, single leaflet device attachment (slda).Details are listed in the attached article, titled ¿institutional learning experience for combined edge-to-edge tricuspid and mitral valve repair.¿ please see article for additional information.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Literature attachment: ¿institutional learning experience for combined edge-to-edge tricuspid and mitral valve repair.¿.

• 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: 9954654
• MDR Text Key: 187730610
• Report Number: 2024168-2020-03601
• 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: health professional,literatur
• Type of Report: Initial,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: 03/22/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 82 YR