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.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• 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
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• 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

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/20/2020 Patient Sequence Number: 1