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

Catalog Number UNK CDS

Device Problem Positioning Failure (1158)

Patient Problems Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Sepsis (2067); Shock (2072); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 01/01/2009

Event Type  Death  

Event Description

The article "transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction" was reviewed.The article presented a retrospective multi center study to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (teer) in the setting of myocardial infarction (mi) induced papillary muscle rupture (pmr).All procedures were completed with a mitraclip system.The article concluded that teer is a feasible therapy in critically ill patients with acute severe primary mitral regurgitation due to a recent mi who are deemed inoperable.The primary author and corresponding author was dan haberman (b)(6) at kaplan medical center in rehovot, israel.The time frame of the study was december 2009 to september 2022.A total of 23 patients were included in this study, of which all but one successfully received an abbott device.Comorbidities included: st-elevation myocardial infarction (stemi), anterior wall myocardial infarction, inferior wall myocardial infarction, coronary artery disease (cad), cardiogenic shock, vasopressors, ventilation, mechanical support (11 iabp, 2 impella, and 4 va-ecmo).Intra, peri and post-procedural complications included clip grasping issues, death, stenosis, sepsis, heart failure, surgical intervention, shock, leaflet rupture, bleeding, intervention (transfusion), and worsening mitral regurgitation.

Manufacturer Narrative

The devices were 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 were not provided.Based on the information reviewed, and due to limited information available from the article (no individual information available) and the article covering multiple patients, a cause for the reported difficult or delayed positioning with leaflet grasping, mitral stenosis, sepsis, heart failure/congestive heart failure, shock, unspecified tissue injury, hemorrhage/blood loss/bleeding, mitral valve insufficiency/regurgitation and death could not be determined; however, mitral stenosis, sepsis, heart failure/congestive heart failure, shock, unspecified tissue injury, hemorrhage/blood loss/bleeding, mitral valve insufficiency/regurgitation and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention, surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: article titled "transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18748685
• MDR Text Key: 335882766
• Report Number: 2135147-2024-00790
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention