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 Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Unspecified Vascular Problem (4441); Mitral Valve Insufficiency/ Regurgitation (4451); Renal Impairment (4499)

Event Date 12/28/2022

Event Type  Death  

Event Description

This is filed to report death.This research article was a prospective single-center observational study designed to evaluate the use of early generation mitral transcatheter edge-to-edge repair (teer) in comparison to the new generation.Complications identified in the study included: single leaflet device attachments (slda), cardiac tamponade requiring pericardiocentesis, acute kidney injury, recurrent mitral regurgitation(mr), minor vascular injuries, bleeding, and death.In conclusion in this series of patients with functional mr, significant changes in mitral valve anatomy after mitral teer with a reduction in anteroposterior diameter, valve perimeter, and area was observed.In the cohort, the extent of these changes was greater with the use of the new-generation g4 mitraclip system compared to prior device generations.No additional information was provided.Details are listed in the attached article titled, "anatomical changes after transcatheter edge-to-edge repair in functional mr according to mitraclip generation.".

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.Additionally, the complaint history 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 of the reported death / expired could not 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.Adverse event and test dates estimated.The udi number is not known as the part and lot number were not provided.The additional patient effects and malfunctions reported in the article are captured under separate medwatch report numbers.Article titled, "anatomical changes after transcatheter edge-to-edge repair in functional mr according to mitraclip generation.".

• 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: 16518005
• MDR Text Key: 311035861
• Report Number: 2135147-2023-01102
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/09/2023

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: 02/15/2023
• Initial Date FDA Received: 03/09/2023
• 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: 74 YR
• Patient Sex: Male