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 Problem Insufficient Information (4580)

Event Date 01/01/2011

Event Type  Death  

Event Description

This is filed to report death.This research article was a retrospective single-center study designed to evaluate the prognostic role of the ratio between the effective regurgitant orifice area (eroa) and left ventricular (lv) end-diastolic volume (edv) on the efficacy of transcatheter edge-to-edge repair (teer).Complications identified in the study included: death, heart failure and hospitalization.In conclusion, the data suggest that the proposed cut-off for eroa/lvedv ratio may not apply to all real-world contexts.Rather, the best candidates for teer seem to be less clinically compromised patients, with a good rv function as assessed by 3dtte, and a mv anatomy conducive to an optimal technical result.No additional information was provided.Details are listed in the attached article titled, "predictors of prognosis in patients with secondary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.".

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 the information reviewed and due to the limited information available from the article, the cause of the reported death was unable to be determined.The reported patient effect of death 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.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 a separate medwatch report number.Attachment: article titled, "predictors of prognosis in patients with secondary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair".

• 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: 16993416
• MDR Text Key: 315855435
• Report Number: 2135147-2023-02289
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/24/2023

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: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• 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: 73 YR
• Patient Sex: Male