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

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2008

Event Type  Injury  

Event Description

This is filed to report atrial fibrillation, hospitalization, heart failure, and atrial flutter.This study investigates the role of left atrial volume index (lavi) in patients with functional mitral regurgitation (mr) undergoing transcatheter-edge-to-edge mitral valve repair (teer).Outcomes were evaluated for all-cause mortality, residual mr and nyha class improvement.Additional adverse effects noted with the mitraclip device atrial fibrillation, hospitalization, heart failure, and atrial flutter.The study concluded that the impact of left atrial enlargement was relevant in patients in the early course of backward congestion for good long-term outcome after teer.Details can be found in the attached article, left atrial volume index and outcome after transcatheter edge-to-edge valve repair for secondary mitral regurgitation.No additional information was provided.

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.Date of event; implant date: dates estimated.The udi is unknown due to the part/lot number was not provided.The additional patient effect of deaths reported in the article are captured under a separate medwatch report.Literature attachment: article title: left atrial volume index and outcome after transcatheter edge-to-edge valve repair for secondary mitral regurgitation.

Event Description

N/a.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history record could not be performed because this complaint was based on an article, and no device/lot information was provided.Based on available information, causes for the reported atrial flutter, atrial fibrillation and heart failure could not be determined.Additionally, the reported patient effects of atrial flutter, atrial fibrillation, and heart failure are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalizations were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14844368
• MDR Text Key: 295058615
• Report Number: 2024168-2022-06972
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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: 06/06/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/15/2022
• 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; Other
• Patient Age: 75 YR
• Patient Sex: Male