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

Catalog Number UNK CDS

Device Problems Positioning Failure (1158); Incomplete Coaptation (2507)

Patient Problems Stroke/CVA (1770); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Perforation (2001); Pneumonia (2011); Renal Failure (2041); Cardiogenic Shock (2262); Pseudoaneurysm (2605); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/31/2012

Event Type  malfunction  

Manufacturer Narrative

Date of event - estimated the unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date is - estimated the clip remains in patient.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.Article attached: acute and midterm outcome after mitraclip therapy in patients with severe mitral regurgitation and left ventricular dysfunction the patient events mentioned in the article and are filed under different medwatch mfr numbers.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, recurrent mitral regurgitation, leaflet perforation, cardiogenic shock, stroke, myocardial infarction, heart failure, pneumonia, atrial perforation, infection, pseudoaneurysm, fistula, bleeding, renal failure, medical intervention, mitral valve replacement, and hospitalization.Device issues include, single leaflet device attachment (slda), and inability to grasp the leaflets.Details are listed in the attached article, titled ¿acute and midterm outcome after mitraclip therapy in patients with severe mitral regurgitation and left ventricular dysfunction.¿ please see article for additional information.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot histories could not be performed as the lot numbers and part numbers are unknown.A query of the echo analytic reporting system (ears) complaint-handling database to determine similar incidents could not be performed as the lot numbers and the part numbers are unknown.Based on the limited available information and no devices to analyze a cause for the reported single leaflet device attachment (slda) and positioning failure (leaflet grasping ¿ clip not implanted) cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11402380
• MDR Text Key: 239512036
• Report Number: 2024168-2021-01651
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR