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 Pulmonary Embolism (1498); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Renal Failure (2041); Shock (2072); Cardiac Tamponade (2226); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This research article was a meta-analysis study designed to discuss in-hospital complications after mitraclip in patients with heart failure and preserved versus reduced ejection fraction in the united states.Complications identified in the study included: acute myocardial infarction, acute kidney injury, major bleeding requiring blood transfusion, intra-operative stroke, post-procedural shock, respiratory failure, deep vein thrombosis (dvt) or pulmonary embolism (pe), cardiac tamponade, mechanical ventilation, atrial fibrillation, hospitalization, and death.In conclusion, in the present study of us patients, those with hfref were observed to have statistically higher risk of in-hospital post-procedural shock and longer hospitalization length of stay when compared with patients with hfpef who underwent mitraclip implantation.Additionally, patients with hfref undergoing mitraclip procedure were observed to have higher absolute rates of certain post-procedural complications, however these observations did not reach statistical significance.Understanding of the aforementioned differences after mitraclip implantation may be useful in-patient selection, prognostic guidance, and hypothesis generation to propel future large clinical studies.Details are listed in the attached article titled, "in-hospital complications after mitraclip in patients with heart failure and preserved versus reduced ejection fraction in the united states".

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effect of death reported in the article is captured under a separate medwatch report.The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported death, respiratory failure, stroke, pulmonary embolism, cardiac tamponade, myocardial infarction, renal failure, hemorrhage, shock, thrombosis, and atrial fibrillation were unable to be determined.The reported patient effects of myocardial infarction, respiratory failure, renal failure, death, cerebrovascular accident, hemorrhage, thrombosis/thrombus, and cardiac tamponade, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled "in-hospital complications after mitraclip in patients with heart failure and preserved versus reduced ejection fraction in the united states.".

• 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: 18351249
• MDR Text Key: 330815607
• Report Number: 2135147-2023-05559
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

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: 11/27/2023
• Initial Date FDA Received: 12/18/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female