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 Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/18/2023
Type of Reportable Event	Death
Event or Problem Description
This report is being filed due to heart failure and death.Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on 08/19/2021, the patient presented with degenerative mitral regurgitation with leaflet prolapse and flail.One mitraclip (cds0701-xtw, 10423r134) was implanted, reducing the mr to grade 2+.There was no device deficiency.On (b)(6) 2021, severe mr was noted.Per physician, the mr was unrelated to the mitraclip device.On (b)(6) 2021, another mitraclip was successfully implanted, reducing the mr.There was no device deficiency with either clip.On (b)(6) 2023, the patient had passed away while at home.Heart failure was noted.Per physician, the event was unknown if related to the index procedure clip.There was no device deficiency.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.
Event or Problem Description
Subsequent to the initial report, the additional information was received: there was no additional mitraclip implanted.There were no device related issues noted following the procedure.The mitraclip had remained stable with mild, residual mitral regurgitation.Pre-existing conditions that would have caused or contributed to the patient¿s death include coronary artery disease with a coronary artery bypass graft in 2019, diabetes (insulin dependent), asthma, end stage renal disease, hypertension, aortic stenosis and regurgitation.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported unrelated mitral regurgitation (mr), heart failure and death could not be determined.It was however, confirmed by the physician that the mr was unrelated to the mitraclip device.Mitral regurgitation, heart failure and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product 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: 18659146
• Report Number: 2135147-2024-00551
• Device Sequence Number: 7317525
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 04/23/2022
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10423R134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Patient Weight: 53 KG