MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Swelling/ Edema (4577)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed due to worsening congestive heart failure and recurrent mitral regurgitation requiring treatment.(b)(6).Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with leaflet tethering, and an anterior leaflet prolapse with flail.One mitraclip was implanted, reducing the mr to grade 1+.On (b)(6) 2023, the patient was hospitalized with dyspnea, lower extremity edema, and acute congestive heart failure was diagnosed.Follow-up was performed with cardiothoracic surgery and progressive, severe mr with an eccentrically directed jet was noted.Medications had been provided as treatment.Reportedly, the patient required multiple rounds of diuresis (medications provided).On (b)(6) 2023, the patient was hospitalized with recurrent mr.During this hospitalization, on (b)(6) 2023, a mitral valve replacement was performed.
Additional Manufacturer Narrative
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, a cause of the reported recurrent mr could not 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 hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with leaflet tethering, and an anterior leaflet prolapse with flail.One mitraclip (cds0701-xtw, 10824r180) was implanted, reducing the mr to grade 1+.On (b)(6) 2023, the patient was hospitalized with dyspnea, lower extremity edema, and acute congestive heart failure was diagnosed.Follow-up was performed with cardiothoracic surgery and progressive, severe mr with an eccentrically directed jet was noted.Medications had been provided as treatment.Reportedly, the patient required multiple rounds of diuresis (medications provided).On (b)(6) 2023, the patient was hospitalized with recurrent mr.During this hospitalization, on (b)(6) 2023, a mitral valve replacement was performed.Subsequent to the previous reports, the additional information was received: the mitraclip had remained stable and well seated.There was no device related tissue injury observed.Per physician, the recurrent mr was device related.Per physician, the worsening heart failure was unrelated to the device.
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 reported dyspnea, lower extremity edema, and acute congestive heart failure appear to be due to recurrent mitral regurgitation (mr).A cause of the reported recurrent mr could not be determined.The reported patient effects of heart failure, dyspnea, edema, and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18683813
• Report Number: 2135147-2024-00598
• Device Sequence Number: 15051840
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10824R180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/21/2024; 03/14/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 02/27/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Disability
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 69 KG