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); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/26/2018

Event Type  Death  

Manufacturer Narrative

The devices will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Outcome, date of event and implant/explant date: dates estimated.The udi number is not known as the part and lot number were not provided the additional serious injury and malfunction reported in the article are captured under a separate medwatch report number.Article titled, "transcatheter edge-to-edge repair for secondary mitral regurgitation with 3rd generation devices in heart failure patients¿results from the global expand post-market study".

Event Description

This will be filed to report death.This research article was a meta-analysis study to report contemporary real-world outcomes in secondary/functional mitral regurgitation patients treated with third generation mitraclip systems.Complications identified in the study included: stroke, heart failure, prolonged hospitalization, surgical intervention, iatrogenic atrial septum defect that required intervention, single leaflet device attachment (slda), and death.In conclusion, under real-world conditions, optimal sustained mr reduction to mr=1+ was achieved in a high percentage of patients with 3rd generation mitraclip, which translated into symptomatic improvement and low event rates.These results appear to be comparable with recent randomized clinical trials.Details are listed in the attached article titled, "transcatheter edge-to-edge repair for secondary mitral regurgitation with third-generation devices in heart failure patients ¿ results from the global expand post-market study".

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 cerebrovascular accident (stroke), heart failure and death could not be determined.The reported cerebrovascular accident (stroke), heart failure and death are listed in the instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention and unexpected medical interventions were the results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2, b3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.The additional serious injury and malfunction reported in the article are captured under a separate medwatch report number.

Event Description

N/a.

• 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: 16311388
• MDR Text Key: 308935633
• Report Number: 2135147-2023-00418
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 03/13/2023

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: 01/13/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/13/2023
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male