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

Catalog Number UNK CDS

Device Problem Positioning Failure (1158)

Patient Problems Stroke/CVA (1770); Dyspnea (1816); Unspecified Infection (1930); Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2018

Event Type  Injury  

Event Description

This study retrospectively analyzed 148 patients with severe mitral regurgitation (mr) who underwent mitraclip implantation between april 2018 and april 2021.The aim of the study is to investigation the effect of controlling nutritional status (conut) score on mortality rates after transcatheter mitral valve repair (tmvr).All-cause death was significantly worse in the high-conut score group than in the low-conut score group.Adverse events that occurred after implantation include the following: all-cause death, cardiovascular death, myocardial infarction, interstitial pneumonia, stroke, 2 patients required mitral valve surgery or a repeat mitraclip procedure, and hospitalization for heart failure (dyspnea and orthopnea) after procedure.In this study, 4 patients were excluded because of the morphology of their mitral valve made mitraclip implantation unfeasible or impossible according to the everest criteria.Preprocedural conut score, as well as mitrascore, in patients undergoing transcatheter edge-to-edge mitral valve repair may predict an increased risk of all-cause death.Details are listed in the attached article titled, "preprocedural controlling nutritional status score as a predictor of mortality in patients undergoing transcatheter mitral valve repair.".

Manufacturer Narrative

The clip remains in the 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.B3: date of event is estimated.D4: the udi is unknown due to the part/lot number was not provided.D6: date of implant is estimated.Article titled ¿preprocedural controlling nutritional status score as a predictor of mortality in patients undergoing transcatheter mitral valve repair.¿ the additional patient effect of death referenced in b5 is captured under a separate medwatch report.

Manufacturer Narrative

The device was 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 number regarding the complaint device was not provided.The investigation determined the reported positioning failure appears to be related to patient morphology/pathology.A cause for the reported deaths, myocardial infraction, infection, cerebrovascular accident, heart failure, and dyspnea cannot be determined.Deaths, myocardial infraction, infection, cerebrovascular accident, heart failure, and dyspnea are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case specific circumstances.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 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: 18439864
• MDR Text Key: 331864503
• Report Number: 2135147-2024-00031
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/12/2024

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: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/12/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male