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 Dyspnea (1816); Edema (1820); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Tricuspid Regurgitation (2112); Heart Failure (2206); Atrial Perforation (2511)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: date estimated.The udi number is not known as the part and lot number were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the information reviewed and due to the limited information available from the article, a cause for the reported heart failure, atrial perforation, edema, tricuspid regurgitation, pulmonary edema, hypertension, and dyspnea cannot be determined.However, heart failure, atrial perforation, edema/pulmonary edema, hypertension, and dyspnea are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Literature.Article title ¿biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair.

Event Description

This is filed to report heart failure, hypertension, edema, atrial perforation, pulmonary edema, worsening tricuspid regurgitation, medical intervention, and prolonged hospitalization,.It was reported through a research article identifying steerable guide catheters that were related to the following outcomes: heart failure, dyspnea, hypertension, edema, atrial perforation, pulmonary edema, worsening tricuspid regurgitation, medical intervention, prolonged hospitalization, and death.Specific patient information is documented as unknown.Details are listed in the article, titled, "biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair.¿ 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: 11309870
• MDR Text Key: 231372768
• Report Number: 2024168-2021-01074
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention