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); Myocardial Infarction (1969)

Event Date 11/22/2023

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause for the reported patient complications (i.E., death, stroke, myocardial infarction, and bleeding) could not be determined as no case-specific detail was provided.The reported patient effects of death, death, cerebrovascular accident, hemorrhage, and myocardial infarction, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Literature attachment: article title "sex-specific disparities in outcomes of transcatheter edge-to-edge repair for mitral regurgitation: a multicenter ¿real-world¿ analysis"na.

Event Description

This research article was a prospective study designed to evaluate whether patient sex impacts procedural safety and efficacy, and in-hospital- and long-term outcomes, after transcatheter edge-to-edge repair (teer) for mitral regurgitation (mr).Complications identified in the study included: death, stroke, myocardial infarction, bleeding complications.In conclusion, teer procedures are equally safe and effective in both sexes.While in-hospital mortality did not differ, female patients experienced a significantly better adjusted long-term survival compared with male patients.It was also shonw that atrial fibrillation, the most common comorbid condition, offsets the prognostic advantage of females over males and, in contrast to males, significantly impairs long-term survival in women undergoing teer.Details are listed in the attached article titled, "sex-specific disparities in outcomes of transcatheter edge-to-edge repair for mitral regurgitation: a multicenter ¿real-world¿ analysis".

• 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: 18326279
• MDR Text Key: 330496339
• Report Number: 2135147-2023-05517
• 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
• Report Date: 12/14/2023

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: 11/22/2023
• Initial Date FDA Received: 12/14/2023
• 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