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)

Event Date 11/27/2016

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 will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment : haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.

Event Description

This is being filed to report the atrial septal defect (asd), heart failure requiring hospitalization and treatment.It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr).The mitraclip was successfully implanted.Fifteen days post procedure the patient showed significant left-to-right shunting eventually leading to the development of right-sided heart failure.The issue was resolved through percutaneous closure with either an amplatzer or figulla occluder.No additional information was provided.Details are listed in the 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 device was not returned for analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.The reported patient effects of perforation (cardiac) and heart failure (worsening) as listed in the mitraclip system instructions for use (ifu) are known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported perforation could not be determined in this complaint.The reported heart failure was a cascading effect of perforation.The reported unexpected medical intervention and hospitalization appear to be due to case specific circumstance as the patient issue was resolved through percutaneous closure with either amplatzer or figulla occluder device.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: 11724551
• MDR Text Key: 247270733
• Report Number: 2024168-2021-03508
• 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: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention