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 Hemorrhage/Bleeding (1888); Rupture (2208); Pseudoaneurysm (2605); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Kidney or Urinary Problem (4503)

Event Date 12/01/2019

Event Type  Death  

Manufacturer Narrative

Date of death - estimated.Date of event - estimated.Implant date - estimated.The clips remain in the patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article title: use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: a multicenter observational experience (mitra-shock study).

Event Description

This is filed to report the patient deaths.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, chordae rupture, acute kidney injury, unchanged mitral regurgitation, hemorrhage, pseudoaneurysm, medical intervention, hospitalization, and surgical intervention.Details are listed in the attached article, titled use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: a multicenter observational experience (mitra-shock study).

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records could not be performed as the part/lot information were not provided.The reported patient effect of death as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported deaths appear to be due to the patients condition.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 11760988
• MDR Text Key: 248533969
• Report Number: 2024168-2021-03695
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 04/09/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR