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); Transient Ischemic Attack (2109); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/27/2023

Event Type  Injury  

Event Description

This is filed to report heart failure, cardiac arrest, myocardial infarction, stroke, and transient ischemic attack.It was reported through a research article that 96 patients underwent transcatheter edge-to-edge repair (teer) from (b)(6) 2013 to (b)(6) 2020.Within one year of undergoing a mitraclip procedure, the implanted mitraclip may have caused or contributed to heart failure, cardiac arrest, myocardial infarction, stroke, transient ischemic attack, hospitalization, medical intervention, and surgical intervention.Additional information is listed in the attached article, titled "transcatheter edge-to-edge repair for chronic functional mitral regurgitation in patients with very severe left ventricular dysfunction.".

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3: date of event estimated.D4: the udi is unknown due to the part/lot number was not provided.D6: date of implant estimated.Attachment: article titled ¿transcatheter edge-to-edge repair for chronic functional mitral regurgitation in patients with very severe left ventricular dysfunction".

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.Based on available information, the cause for the reported patient effects of heart failure, cardiac arrest, myocardial infarction, stroke, and transient ischemic attack (tia) could not be determined as no case-specific details were provided.Cardiac arrest, heart failure, myocardial infarction, transient ischemic attack, and cerebrovascular accident, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, unexpected medical intervention (mitral re-interventions, non-teer interventions) were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 17267980
• MDR Text Key: 318548815
• Report Number: 2135147-2023-02907
• 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,Followup
• Report Date: 08/03/2023

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: 06/14/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/03/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male