MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN MITRACLIP CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Stroke/CVA (1770); Mitral Regurgitation (1964); Ventricular Tachycardia (2132); Respiratory Failure (2484)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of events, implant date: dates estimated.Exemption number: (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional patient effects listed are being filed under a separate medwatch report.

Event Description

This is filed to report stroke, respiratory failure, ventricular tachycardia, unchanged mitral regurgitation (mr), additional therapy and hospitalization.It was reported through a research article identifying a mitraclip device that may be related to the following: death, stroke, respiratory failure, ventricular tachycardia, unchanged mitral regurgitation (mr), additional therapy and hospitalization.Details are listed in the attached article titled: effect of successful edge-to-edge mitral valve repair on ventricular arrhythmic burden in patients with functional mitral regurgitation and implantable cardiac devices.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot information was not provided.The reported patient effects of mitral regurgitation(mr), cerebrovascular accident, respiratory failure, ventricular tachycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a definitive cause for reported patient effects could not be determined.Although a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: article titled, effect of successful edge-to-edge mitral valve repair on ventricular arrhythmic burden in patients with functional mitral regurgitation and implantable cardiac devicesna - attachment: [article.Pdf].

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: UNKNOWN MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9072483
• MDR Text Key: 158717816
• Report Number: 2024168-2019-11817
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

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
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 07/20/2020
• Supplement Dates FDA Received: 11/12/2019; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR