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

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

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Respiratory Distress (2045); Tricuspid Regurgitation (2112); Heart Failure (2206); Cardiogenic Shock (2262); Atrial Perforation (2511)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.(udi#): in the absence of a reported part number, the udi number cannot be calculated.The clip remains implanted.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report post mitraclip procedure,hypoxia, atrial perforation, shock cardiogenic, cardiac arrest, hypertension, heart failure, worsening tricuspid regurgitation, recurrent mitral regurgitation, and rehospitalization occurred.It was reported through a research article identifying the mitraclip device which may be related to patient hypoxia, atrial perforation, shock cardiogenic, cardiac arrest, hypertension, heart failure, worsening tricuspid regurgitation, recurrent mitral regurgitation, and rehospitalization.Specific patient information is documented as unknown.Details are listed in the attached article, iatrogenic atrial septal defect following the mitraclip procedure: a state-of-the-art review.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 lot and part number was not provided.Based on the information available, a definitive cause for the reported patient effects could not be determined.The patient effects of atrial perforation, shock cardiogenic, cardiac arrest, hypertension, heart failure and mitral regurgitation are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.Hospitalization were a result of case-specific circumstances as the patient was re-hospitalized.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, 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: 10432961
• MDR Text Key: 203866528
• Report Number: 2024168-2020-06969
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization