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 Problems Mitral Regurgitation (1964); Heart Failure (2206); Atrial Perforation (2511)

Event Date 11/27/2018

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.Literature titled, left atrial pressure is associated with iatrogenic atrial septal defect after mitral valve clip.

Event Description

This is filed to report atrial perforation, heart failure and recurrent mitral regurgitation.It was reported through a research article that 131 patients underwent a mitraclip procedure and had an atrial septal defect after the procedure was completed.Within 12 months of the procedure, multiple patient still had a left to right shunt, which resulted in recurrent mitral regurgitation and increased left atrium pressure.It was also noted that within the 12 months, three patients underwent mitral valve repair.Details are listed in the article, titled ¿left atrial pressure is associated with iatrogenic atrial septal defect after mitral valve clip.¿ 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, the reported atrial perforation appears to have been a result of procedural conditions.The recurrent mitral regurgitation (mr) appears to have been a cascading event of the reported atrial perforation.The reported patient effects of atrial perforation and recurrent mr, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical procedure and hospitalization were results of case-specific circumstances.As patients were re-hospitalized and underwent mitral valve repair surgery for treatment of the recurrent mr.There is no indication of a product quality 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: 11170450
• MDR Text Key: 226806201
• Report Number: 2024168-2021-00440
• 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: 02/18/2021

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 SGC03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR