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

Catalog Number UNK SGC01

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

Patient Problems Perforation (2001); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated date.Udi #: the udi number is not known as the part and lot number were not provided.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The patient death and other adverse events referenced in the article are captured under separate medwatch reports.

Event Description

This is being filed to report atrial septal defects, heart failure, mitral regurgitation, tricuspid regurgitation, intervention, and hospitalization.It was reported through a research article identifying mitraclip steerable guide catheter that may be related to atrial septal defects, heart failure, mitral regurgitation, tricuspid regurgitation, intervention, and hospitalization.No additional information was provided.Specific patient information is documented as unknown.Details are listed in the attached article: haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.

Manufacturer Narrative

D4: the udi# is unknown because the part and lot numbers were not provided.The devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information regarding the complaint devices were not provided.The reported patient effects of perforation, heart failure, mitral regurgitation (mr), and tricuspid regurgitation (tr) as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported perforation, heart failure, recurrent mr, and recurrent tr cannot be determined.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.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: 11725040
• MDR Text Key: 247289607
• Report Number: 2024168-2021-03521
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention