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

Catalog Number	CDS0701-NTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on 01-july-2021, the patient presented with degenerative mitral regurgitation (mr) with anterior and posterior leaflet prolapse.Two mitraclips (cds0701-ntw, 10205u378 and cds0701-nt, 10118u217) were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, the patient was hospitalized with acute metabolic encephalopathy and a left sided facial droop.Per imaging, an ischemic stroke was diagnosed.Reportedly, the patient¿s anticoagulation medications were recently held for a gastrointestinal evaluation.Medications were provided and the patient went to inpatient rehabilitation.The stroke event resolved.On (b)(6) 2023, mitral valve stenosis was diagnosed.No treatment was provided for the stenosis.Reportedly, the event was chronic with heart failure sequela.There was no device malfunction.
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 stroke, heart failure and mitral stenosis were unable to be determined.The reported patient effects of cerebrovascular accident, heart failure, and mitral stenosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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 hypertension was unable to be determined.The reported patient effect of hypertension, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previous report, the additional information was obtained: pulmonary hypertension was diagnosed during the august hospitalization.No treatment was provided for the pulmonary hypertension.

• 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: 18565671
• Report Number: 2135147-2024-00337
• Device Sequence Number: 20535781
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: 02/10/2022
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10205U378
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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: Hospitalization; Disability; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 52 KG