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 Mitral Valve Stenosis (1965); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database for the reported lot could not be performed as the lot number and part number are unknown.Based on the information reviewed, and due to limited information available from the article the cause for the reported mitral regurgitation (mr), mitral stenosis (ms), tissue injury, heart failure and sepsis could not be determined.The reported mr, ms, tissue injury, heart failure and sepsis are listed in the instructions for use (ifu) and are known possible complication associated with mitraclip procedures.The reported medical intervention was the results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.The additional patient deaths reported in the article are captured under a separate medwatch report number.Literature attachment: "percutaneous transcatheter mitral valve repair: combining devices for challenging anatomies".

Event Description

This is filed to report mitral stenosis, recurrent mitral regurgitation, heart failure, sepsis, chordal rupture.This research article was a retrospective study designed to evaluate patients treated with mitral transchatheter edge-to-edge repair (m-teer) needing a combined therapy with occluders.Complications identified in the study included: unexpected medical intervention, recurrent mitral regurgitation (mr), mitral stenosis, chordal rupture, heart failure, sepsis, and death.In conclusion the placement of an interclip or commissural occluder device after m-teer may be a valid option for patients with challenging anatomies and significant symptomatic residual mr after m-teer with no additional options.No additional information was provided.Details are listed in the attached article titled, "percutaneous transcatheter mitral valve repair: combining devices for challenging anatomies".

• 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: 16776666
• MDR Text Key: 313653407
• Report Number: 2135147-2023-01721
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/20/2023

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: 03/31/2023
• Initial Date FDA Received: 04/20/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male