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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported slda, death, cerebrovascular accident, myocardial infarction, tissue injury, and heart failure were unable to be determined.The reported patient effects of cerebrovascular accident, death, myocardial infarction, tissue injury, and heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled "two-year clinical outcome of mitraclip transcatheter edge-to-edge repair from the j-mitra registry data.".

Event Description

The article "two-year clinical outcome of mitraclip transcatheter edge-to-edge repair from the j-mitra registry data" was reviewed.The article presented a retrospective multi-center study, to evaluate the 2-year clinical outcomes of all consecutively treated patients who underwent mitraclip implantation in japan and were prospectively enrolled in the j-mitra registry.Devices mentioned include the mitraclip.The article concluded that mitraclip is a viable option with promising clinical outcomes under specific circumstances, even in the context of degenerative mitral regurgitation.[the primary authors were teruhiko imamura, md, phd, second department of internal medicine, university of toyama, toyama, japan; michikazu nakai, phd, clinical research support center, university of miyazaki hospital, miyazaki, japan.The corresponding author was : koichiro kinugawa, md, phd, second department of internal medicine, university of toyama, toyama, japan with corresponding email : kinugawa-tky@umin.Ac.Jp].The time frame of the study was april 2018 and december 2020.A total of 2739 patients were included in this study, of which all received an abbott device.The average age of the patients enrolled was 78.The majority gender was male.As this is from a literature review, patient weight was not provided.Comorbidities included: degenerative mitral regurgitation, functional mitral regurgitation, diabetes, myocardial infarction, hypertension, previous percutaneous intervention, previous cardiac surgery, stroke, peripheral vascular disease, chronic pulmonary disease, atrial fibrillation, renal failure, heart failure, cardiac resynchronization therapy, tricuspid regurgitation, heart failure medication.(b)(6) - intra, peri and post-procedural complications included single leaflet device attachment (slda), leaflet damage, cardiovascular death, non-cardiovascular death, heart failure, hospitalization, stroke, myocardial infarction, re-vascularization, surgical intervention (valve replacement), unexpected medical intervention (additional mitraclip).(b)(6) - intra, peri and post-procedural complications included death, atrial septal defect requiring intervention.

• 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: 18979885
• MDR Text Key: 339258986
• Report Number: 2135147-2024-01348
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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