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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Pseudoaneurysm (2605); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date - estimated.The clips remain in the patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment.Article title: use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: a multicenter observational experience (mitra-shock study).

Event Description

This is filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, chordae rupture, acute kidney injury, unchanged mitral regurgitation, hemorrhage, pseudoaneurysm, medical intervention, hospitalization, and surgical intervention.Details are listed in the attached article, titled ¿use of edge-to-edge percutaneous mitral valve repair for severe mitral regurgitation in cardiogenic shock: a multicenter observational experience (mitra-shock study).

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records could not be performed as the part/ lot information were not provided.Unspecified tissue injury, mitral regurgitation (mr), hemorrhage, pseudoaneurysm, and renal failure, are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported unspecified tissue injury, unchanged mitral regurgitation, hemorrhage, pseudoaneurysm and renal failure cannot be determined.The reported unexpected medical intervention, surgical intervention and hospitalization were results of case-specific circumstances as intervention, surgery and re-hospitalization were also reported in the article.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: 11760996
• MDR Text Key: 248526307
• Report Number: 2024168-2021-03696
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 04/09/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/11/2021
• 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; Required Intervention; Disability
• Patient Age: 73 YR