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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a single leaflet device attachment.It was reported that a mitraclip procedure was performed on an unknown date.A mitraclip was implanted successfully.On (b)(6) 2022 the patient returned with a suspected single leaflet device attachment (slda).No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received: the patient also returned with recurrent/worsening mitral regurgitation.No additional intervention was performed or will be performed.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review and similar complaint review were not performed because no device/lot information was provided.Based on the information reviewed, a cause for the reported incomplete coaptation associated with single leaflet device attachment (slda) could not be determined.Mitral regurgitation (mr) is listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported mr appears to be related to slda.The reported serious injury/ illness/ impairment was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.H1: report type updated to serious injury h6: health effect codes 4582 and 2199 were removed.

• 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: 16074948
• MDR Text Key: 307794794
• Report Number: 2135147-2022-02763
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

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?: Yes
• 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: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/20/2023
• 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): Other