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

Catalog Number CDS0602-XTR

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

Patient Problems Edema (1820); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 12/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for tissue damage.This event was captured based on literature review of the article: "an unusual cause of recurrent mitral regurgitation after percutaneous mitral valve repair", which identified a (b)(6) patient with severe degenerative mitral regurgitation (mr) with a posterior leaflet prolapse and a p2/p3 flail that underwent a mitraclip procedure.Three months post-procedure, the patient was readmitted with acute lung edema, recurrent mr and chordal rupture requiring a second mitraclip intervention.No additional information was provided.Details are listed in the attached article.

Manufacturer Narrative

Attachment: "an unusual cause of recurrent mitral regurgitation after percutaneous mitral valve repair" the device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint devices was not provided.The reported patient effect of edema, worsening mitral regurgitation (mr) and chordal rupture (tissue damage), as listed in the mitraclip system instructions for, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a cause for the reported tissue damage resulting in mr and edema cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9572520
• MDR Text Key: 175075921
• Report Number: 2024168-2020-00541
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

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: CDS0602-XTR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/17/2020; 07/20/2020
• Supplement Dates FDA Received: 01/22/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR