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

Catalog Number UNK SGC01

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

Patient Problems Arrhythmia (1721); Heart Failure (2206); Atrial Perforation (2511)

Event Date 01/16/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: literature titled, hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.

Event Description

This is filed to report atrial perforation and heart failure.It was reported through a research article that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+.Prior to inserting the device, it was noted that a patent foramen ovale (pfo) was present.One clip was successfully implanted, reducing mr to a grade of 1+.However, after the steerable guide catheter (sgc) was removed, a left to right shunt was observed.The patient was stable, so no additional treatment was performed.Two weeks after the procedure, the patient returned to the hospital with right sided cardiac failure and super ventricular arrhythmia.It was then observed that the left to right shunt had worsened; therefore, an amplatzer closer device was implanted to treat the atrial septal defect.Details are listed in the attached article, titled ¿hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.¿ no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, it appears that the atrial perforation was likely a result of user technique/procedural conditions.The reported heart failure and arrhythmia appear to have been cascading events of the worsening atrial perforation.The reported patient effects of atrial perforation, heart failure, and arrhythmia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances, as the patient was re-hospitalized due to heart failure, and a closure device was implanted to treat the atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 11170771
• MDR Text Key: 226820795
• Report Number: 2024168-2021-00442
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR