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

Catalog Number UNK CDS

Device Problem Insufficient Information (3190)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 07/08/2022

Event Type  Injury  

Event Description

This report is being filed due to recurrent mitral regurgitation.Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6) it was reported that on (b)(6)2021, the patient presented with degenerative mitral regurgitation (mr) with posterior leaflet prolapse.Two mitraclips were successfully implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6)2022, recurrent mr grade 2+ was noted on a follow-up.The increase was deemed device related.An unspecified device issue was noted.It was not specified which clip the issue was associated with.There was no unplanned hospitalization and no treatment.

Manufacturer Narrative

D4: the unique device identifier (udi) number is unknown because the complaint part and lot numbers were not provided.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 the limited information provided, the cause of the reported recurrent mr was unable to be determined.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result 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: 18826038
• MDR Text Key: 336851763
• Report Number: 2135147-2024-00949
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: 02/09/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 76 KG