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 Perforation (2001)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

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.Date of event is estimated.Article title: percutaneous mitral valve repair assisted by a catheter-based circulatory support device in a heart transplant patient.

Event Description

This is filed to report a perforation it was reported through an article that a patient that had cardiogenic shock (cs) after a heart transplantation and was stabilized with temporary mechanical circulatory support (tempmcs), needed to undergo a mitraclip procedure to treat functional mitral regurgitation (mr).One clip was implanted, successfully treating the patient.However, after the procedure, a left to right shunt was observed.Additional details are listed in the attached article, titled ¿percutaneous mitral valve repair assisted by a catheter-based circulatory support device in a heart transplant patient.¿.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as this complaint was based on an article review and the specific part/lot number are unknown.Based on the available information, the reported perforation was due to procedural conditions.The reported cardiac perforation is listed in the instructions for use (ifu) as 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: 12269295
• MDR Text Key: 264811833
• Report Number: 2024168-2021-06774
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• 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: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR