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

Catalog Number UNK CDS

Device Problems Break (1069); Incomplete Coaptation (2507); Expulsion (2933); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

This is filed to report the device malfunctions.It was reported the coapt post-approval study (pas) is a prospective, single arm, multi-center, observational real-world surveillance plan to confirm the long-term safety and effectiveness of the mitraclip¿ system in hf patients with smr.The annual follow-up data identified deaths after 1 year, annular rupture, aortic dissection, atrial fibrillation, bleeding, cardiac arrest, cardiac perforation, complete leaflet clip detachment, arrhythmia, device embolization, device fracture, device migration, device retrieval, device thrombosis, endocarditis, heart failure, medical intervention, mitral leaflet or subvalvular injury, myocardial infarction, pulmonary embolism, readmission, reintervention, single leaflet device attachment, stroke and transient ischemic attack (tia).Information was obtained by linkage to the cms fee-for-service (ffs) claims database.No additional information was provided.Details are listed in the attached report, titled ¿the coapt secondary mr post-approval study annual progress report 2023.¿.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Implant and event dates estimated.The udi number is not known as the part and lot numbers were not provided.The additional patient deaths and serious injuries reported in the coapt trial are captured under a separate medwatch report.Attachment: report titled "the coapt secondary mr post-approval study annual progress report 2023".

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 available information and without the device to analyze the cause of the reported death, heart failure, endocarditis, myocardial infarction (mi), cerebrovascular accident, tissue injury, arrhythmia, hemorrhage, cardiac arrest, embolism, thrombus, pulmonary embolism, transient ischemic attack (tia), atrial fibrillation, incomplete coaptation, migration (partial clip movement), break and expulsion cannot be determined.The reported death, heart failure, endocarditis, myocardial infarction (mi), cerebrovascular accident, tissue injury, arrhythmia, hemorrhage, cardiac arrest, embolism, thrombus, pulmonary embolism, transient ischemic attack (tia) and atrial fibrillation are listed in the instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported removal of foreign body, hospitalization, medical intervention and surgical intervention were 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 numbers were not provided.The additional patient effects reported in the article are captured under separate medwatch report(s)na.

• 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: 16570334
• MDR Text Key: 311701614
• Report Number: 2135147-2023-01248
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• 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 Age: 72 YR
• Patient Sex: Male