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

Catalog Number UNK CDS

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

Patient Problems Stroke/CVA (1770); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Perforation (2001); Pulmonary Edema (2020); Renal Failure (2041); Cardiogenic Shock (2262); Pseudoaneurysm (2605); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/31/2012

Event Type  Injury  

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: acute and midterm outcome after mitraclip therapy in patients with severe mitral regurgitation and left ventricular dysfunction.The patient deaths and device events mentioned in the article are filed under different medwatch mfr numbers.

Event Description

This is filed to report the serious injuries.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 article, titled ¿acute and midterm outcome after mitraclip therapy in patients with severe mitral regurgitation and left ventricular dysfunction.¿.

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.The reported patient effects of stroke (cerebrovascular accident), atrial septal defect requiring intervention (atrial perforation), infection, fistula, worsening heart failure, worsening mitral regurgitation, tissue damage, myocardial infarction, cardiogenic shock, edema, renal insufficiency, pseudoaneurysm, and hemorrhage, as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.Based on the limited available information, a cause for the reported patient effects of cerebrovascular accident, atrial perforation (percutaneous intervention), infection, fistula, heart failure, worsening mitral regurgitation, tissue damage, myocardial infarction, cardiogenic shock, pulmonary edema, renal failure (dialysis required), pseudoaneurysm, hemorrhage, additional therapy/non-surgical treatment (blood transfusion, additional procedure mitral valve, iabp, pti), surgical procedure (major surgery) and hospitalization 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: 11402379
• MDR Text Key: 234408263
• Report Number: 2024168-2021-01650
• 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?: 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: 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 Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR