MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC03

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

Patient Problem Atrial Perforation (2511)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.In the absence of a reported part number, the udi cannot be calculated.The device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The implanted clip is filed under a separate medwatch report number.Literature attachment.Article title ¿mitraclip removal during left ventricular assist device implantation".

Event Description

This is filed to report atrial perforation.It was reported through a research article that in 2014, a mitraclip procedure was performed to treat mitral regurgitation (mr) with a grade of 4.Three clips were successfully implanted, reducing mr to a grade of 2.The patient returned to the hospital in 2018 with symptoms of heart failure.Echocardiography was performed and showed that mr had increased to a grade of 4.In (b)(6) 2018, the patient underwent left ventricular assist device implantation and surgical removal of the implanted clips.An atrial septal deflect (asd) was then noticed, so an asd closure device was implanted.Details are listed in the attached article, titled ¿mitraclip removal during left ventricular assist device implantation.¿ no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information provided the reported atrial perforation is the result of procedural conditions as an atrial puncture is required in order to access the mitral valve.The reported patient effect of atrial perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10541300
• MDR Text Key: 207171738
• Report Number: 2024168-2020-07753
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR