MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Positioning Failure (1158)

Patient Problems Stroke/CVA (1770); Embolism (1829); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Renal Failure (2041); Tissue Damage (2104); Transient Ischemic Attack (2109); Heart Failure (2206); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Atrial Perforation (2511)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Date of implant: estimated.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The death referenced in the article is submitted under a separate mfr report #.Article: percutaneous repair or medical treatment for secondary mitral regurgitation.

Event Description

It was reported through a research article identifying the mitraclip device which maybe be related to patient hemorrhage, tissue damage, atrial perforation, cardiogenic shock, cardiac embolism, stroke, cardiac tamponade, heart transplantation, ischemic stroke, myocardial infarction, renal failure, infections, heart failure, rehospitalization and difficult to grasp the leaflets.Details are listed in the article, titled percutaneous repair or medical treatment for secondary mitral regurgitation.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.The investigation was unable to determine a cause for the difficulty grasping and the patient effects of hemorrhage, tissue damage, atrial perforation, cardiogenic shock, embolism, cerebrovascular accident, cardiac tamponade, heart failure, transient ischemic attack, myocardial infarction, renal failure and infection.Hemorrhage, tissue damage, atrial perforation, cardiogenic shock, embolism, cerebrovascular accident, cardiac tamponade, heart failure, transient ischemic attack, myocardial infarction, renal failure and infection are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The hospitalization, surgical procedure and additional therapy/non-surgical treatment were a result of case-specific circumstances as the patient remained hospitalized and underwent percutaneous mitral-valve repair in addition to receiving medical therapy.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10844186
• MDR Text Key: 216379800
• Report Number: 2024168-2020-09557
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR