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

Model Number	CDS0701-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed due to mitral stenosis.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 chronic, ischemic mixed moderate mitral regurgitation (mr), with anterior leaflet prolapse.Two mitraclips were implanted, reducing the mr to grade 1+.Post-procedure, the gradient was noted at 13mmhg.On (b)(6) 2021, a follow-up echocardiogram was performed.The mean mitral valve gradient remained elevated at 8mmhg.Mitral stenosis was diagnosed.No treatment was reported.On (b)(6) 2022, worsening pulmonary hypertension was diagnosed.Reportedly, the patient has a history of obstructive sleep apnea and is compliant with cpap machine.Per physician, the hypertension was device related.There was no device malfunction.There was no additional hospitalization and no treatment provided.No additional information was provided regarding this issue.
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 the available information the cause of the reported mitral stenosis (ms) cannot be determined.The reported hypertension appears to be due to patient anatomy.The reported hypertension & ms are listed in the mitraclip system instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment was the result 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
• 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: 16787614
• Report Number: 2135147-2023-01762
• Device Sequence Number: 20267025
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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: 05/13/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10513R143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 76 KG