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

Catalog Number	CDS0701-NT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.
Event or Problem Description
Subsequent to the previously filed final report, the additional downgrading information was received on 01/07/2025: there was no device malfunction with either clip.The recurrent regurgitation is unrelated to the mitraclip devices.
Additional Manufacturer Narrative
H2 correction: b1 -- product problem removed.H6 -- health effect clinical code 4451 removed.Health effect impact code 4614 removed.Medical device problem code 3190 removed.Subsequent to the previously filed report, additional downgrading information was received that there was no device malfunction.The updated investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported unrelated recurrent mitral regurgitation (mr) was unable to be determined.There remains no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• 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
• Report Number: 2135147-2024-00949
• Device Sequence Number: 15390806
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 00731U111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 01/07/2025; 02/07/2025
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/22/2024; 01/31/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 76 KG