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 Cardiac Arrest (1762); Stroke/CVA (1770); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This is filed to report medical intervention, surgical intervention, stroke, myocardial infarction, cardiac arrest, hemodialysis, deep venous thrombo-embolism hospitalization this research article was a meta-analysis study designed to evaluate the incidence of repeat mitral valve interventions within 90 days after a mitral valve transcatheter edge to edge repair (mteer) procedures.Complications identified in the study included: death, medical intervention, surgical intervention, stroke, myocardial infarction, cardiac arrest, hemodialysis, deep venous thrombo-embolism hospitalization,.In conclusion the low feasibility of mv repair after failed mteer and the unfavorable outcomes of repeat mv interventions, should be part of the decision making for patients being considered for mteer.Details are listed in the attached article titled, "repeat mitral valve interventions after failed transcatheter edge-to-edge repair with mitraclip".

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.D6 - the implant date is estimated.The additional patient effect of death reported in the article is captured under a separate medwatch report.The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported death, cerebrovascular accident, myocardial infarction, renal failure, cardiac arrest, and thrombosis/thrombus were unable to be determined.The reported patient effects of death, cerebrovascular accident, myocardial infarction, renal failure, and thrombosis/thrombus as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, surgical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality 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: 17885918
• MDR Text Key: 325085391
• Report Number: 2135147-2023-04360
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/06/2023

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 CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/06/2023
• 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): Required Intervention; Hospitalization