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

Catalog Number UNK CDS

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Exemption number (b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The steerable guide catheter(s) referenced are filed under a separate medwatch report number.Attachment: article titled, provisional closure of an iatrogenic atrial septal defect for shunt reversal after transcatheter treatment of tricuspid regurgitation.

Event Description

This is filed to report recurrent mitral regurgitation (mr).It was reported through a research article that a mitraclip procedure was performed to treat mitral regurgitation.However, due to short term failure of the mitraclip, the patient presented with dyspnea and increased mitral regurgitation (mr).Therefore, mitral valve replacement surgery was performed.After the procedure, transesophageal echocardiogram (tee) revealed a bidirectional shunt flow through the residual iatrogenic atrial septal defect (asd).To close the asd, a 14mm amplatzer device was used.Please see article for details.No additional information was provided.

Manufacturer Narrative

Date of event: date estimated.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 analysis and a review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.The reported patient effects of worsening mitral regurgitation (mr) and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported short-term failure of the mitraclip and the reported patient effect of mr likely resulting in the dyspnea cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment: provisional closure of an iatrogenic atrial septal defect for shunt reversal after transcatheter treatment of tricuspid regurgitation.

Event Description

It was reported through a research article that a mitraclip procedure was performed to treat mitral regurgitation.However, due to short term failure of the mitraclip, the patient presented with dyspnea and increased mitral regurgitation (mr).Therefore, mitral valve replacement surgery was performed.After the procedure, transesophageal echocardiogram (tee) revealed a bidirectional shunt flow through the residual iatrogenic atrial septal defect (asd).To close the asd, a 14mm amplatzer device was used.Please see article for additional information.

Manufacturer Narrative

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

• Brand Name: UNKNOWN MITRACLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9250547
• MDR Text Key: 164435576
• Report Number: 2024168-2019-13007
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/06/2019; 07/20/2020
• Supplement Dates FDA Received: 11/26/2019; 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: 73 YR