MAUDE Adverse Event Report: ABBOTT MEDICAL 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); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Renal Failure (2041); Pericardial Effusion (3271)

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effect of death reported in the article is captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article " frailty, preintervention complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair" was reviewed.This article presented a retrospective single center study which hypothesized that preintervention complications may be more common in frail patients undergoing transcatheter mitral and tricuspid valve repair (tmtvr) and may be particularly relevant to clinical outcomes in frail patients.The study examined the frequency of post-procedural complications such as infection, bleeding, and acute kidney injury (aki) by frailty status and their impact on subsequent patient outcomes.The article concluded that bleeding complications and infections were more frequent in frail patients undergoing transcatheter mitral and tricuspid valve repair and partly explained the longer hospital stay.Some of the complications were associated with higher long-term mortality, this did not explain the strong association between frailty and mortality.Further research is warranted to explore interventions targeting periprocedural complications to improve outcomes in this vulnerable population.[the primary author was matthieu schäfer.The corresponding author was matthieu schäfer, university of cologne, faculty of medicine and university hospital cologne, clinic iii for internal medicine, köln, germany.Email: (b)(6).The time frame of this study was from may 2014 and december 2019.Vital status was assessed in march 2021.A total of 626 patients were included in this study, of which all received a mitraclip or triclip device.Comorbidities included: hypertension, atrial fibrillation, chronic kidney disease, dialysis, diabetes mellitus, chronic obstructive pulmonary disease, peripheral artery disease, coronary artery disease, previous cardiac surgery, frailty, diabetes, prior myocardial infarction, heart failure new york heart association class iii - iv, primary mitral regurgitation (mr), secondary mr, mixed mr, and tricuspid regurgitation.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information was not provided.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported hemorrhage/bleeding, pericardial effusion, cerebrovascular accident/stroke, myocardial infarction, renal failure, infection, death and higher rates of postoperative delirium (appropriate code not available) and agitation (appropriate code not available) cannot be determined.However, hemorrhage, myocardial infarction (mi), cerebrovascular accident/stroke, renal failure, pericardial effusion, infection and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical interventions, surgical interventions, medication required, and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional patient effect of death reported in the article is captured under a separate medwatch report.

• 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: 18913473
• MDR Text Key: 337774470
• Report Number: 2135147-2024-01136
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention