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

Catalog Number UNK CDS06

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

Patient Problems High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This is filed to report heart failure, high stress blood volume / unfavorable hemodynamics (hypertension), and prolonged hospitalization.For this retrospective analysis, the objective was to investigate the role of stressed blood volume (sbv) in patients with severe tricuspid regurgitation (tr).Consecutive patients with severe symptomatic functional tricuspid regurgitation (tr) undergoing right heart catheterization (rhc) prior to isolated transcatheter tricuspid edge-to-edge-repair (teer) at the heart center leipzig, were included between 2016 and 2021.Teer was carried out either with the triclip, mitraclip, or a non-abbott device.Procedural success was defined as successful device placement and tr reduction of at least one grade at discharge.A one month follow-up for symptoms and echocardiography indicated higher sbv and unfavorable hemodynamics for some patients.Adverse events that were noted: 82 patients (29%) died, 36 patients (13%) were hospitalized for heart failure (hf).Patients with tricuspid regurgitation remain at high risk for heart failure events after valve repair.This study demonstrates that the assessment of volume status and its functional distribution between stresses and unstressed components, allows for risk stratification following teer.Higher stressed blood volume was associated with less reductions of central venous pressures in response to tricuspid repair and a strong predictor of subsequent mortality and heart failure hospitalizations.Details are listed in the article titled, "stressed blood volume in severe tricuspid regurgitation implications for transcatheter treatment.".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database for the reported lot could not be performed as the lot number and part number are unknown.Based on the information reviewed, and due to limited information available from the article the cause for the reported hypertension, death and hf could not be determined.Additionally, the reported patient effects of hypertension, hf and death are listed in the instructions for use, potential complications and adverse events section) and are known possible complications associated with mitraclip procedures.The reported hospitalization was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A2: mean age.A3: majority gender.B3: date of event is estimated.D4: the udi is unknown as the part and lot numbers were not provided.D6a: date of implant is estimated.Deaths reported in the article are captured under a separate medwatch report.

• Brand Name: MITRACLIP NTR 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: 17809055
• MDR Text Key: 324216712
• Report Number: 2135147-2023-04159
• 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
• Report Date: 09/25/2023

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 CDS06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Female