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

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Mitral Valve Stenosis (1965); Renal Failure (2041); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported migration, deaths, renal failure, infection, cardiac tamponade, hemorrhage, cerebrovascular accident, heart failure, mitral stenosis, mr, and intracranial hemorrhage.Death, renal failure, infection, cardiac tamponade, hemorrhage, cerebrovascular accident, heart failure, mitral stenosis, mr, and intracranial hemorrhage are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, hospitalization and unexpected medical interventions were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B3: date of event was estimated.B5: the device malfunction and death are filed under separate medwatch reports.D4: the udi is unknown as the part and lot numbers were not provided d6a: date of implant was estimated.Attachment: article titled "complications following transcatheter edge-to-edge mitral valve repair: personal experience and review of the literature.".

Event Description

This is filed to report renal failure, deep wound infection, re-intervention, mechanical ventilation, gastrointestinal (gi) complication with surgery, pericardial tamponade, hemorrhage, hemorrhagic stroke, major vascular complications, worsened heart failure, pericardial tamponade, relevant mitral stenosis, stroke, cerebrovascular events, unchanged mitral regurgitation (mr), and worsened mr.The aim of this systematic review is to discuss the technical details of the mitraclip procedure, clinical evidence regarding the efficacy of mitraclip, complications related to the clip implantation alongside with acute complications based on the currently available evidence and clinical experience.The focus was on the results of the following clinical trials: mitra-fr trial, everest phase i (endovascular valve edge-to-edge repair study), everest cohort, access-eu, grasp, transcatheter mitral valve interventions (trami), coapt (cardiovascular outcomes assessment of the mitraclip percutaneous therapy for heart failure patients with functional mitral regurgitation), sts/acc tvt and mitral valve replacement (mvr) with extended clip arms.This article also included summary data from in-hospital complications from the medical university of warsaw between august 2014 and november 2022 who underwent a mitraclip procedure.Adverse effects listed were as follows: renal failure, deep wound infection, re-intervention, mechanical ventilation, gi complication with surgery, pericardial tamponade, death, hemorrhage, hemorrhagic stroke, stroke, major vascular complications, worsened heart failure, pericardial tamponade, relevant mitral stenosis, cardiovascular mortality, cerebrovascular events, unchanged mr, and worsened mr.Device related issues included partial clip detachment.Details can be found in the attached article titled: "complications following transcatheter edge-to-edge mitral valve repair: personal experience and review of the literature".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17198631
• MDR Text Key: 317829629
• Report Number: 2135147-2023-02743
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization