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

Catalog 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	07/10/2023
Type of Reportable Event	Serious Injury
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 mitral stenosis, hypertension, and mitral regurgitation cannot be determined.Additionally, the reported patient effects of ms, hypertension, and mr are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances as medications were administered to treat the reported patient effect.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
This is filed to report 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 mixed mitral regurgitation (mr) with a2 flail.Two mitraclips (cds0701-ntw, 00929u205 and cds0701-nt, 10108u275) were implanted, reducing the mr to grad 1+.There was no complication and no device deficiency.On (b)(6) 2023, mitral valve stenosis with cascading pulmonary hypertension was diagnosed.The stenosis will be monitored.Moderate mr (grade 2+) was also noted.On (b)(6) 2023, a scheduled right heart catheterization was performed.Moderate mitral stenosis and pulmonary hypertension were observed.The mitral valve had thickened leaflets with eccentric moderate mr.The elevated pressures indicated volume overload and worsening heart failure was diagnosed.Medications were provided as treatment.There was no additional hospitalization.The conditions are chronic with sequela.Per physician, the recurrent mr (grade 2+) was unrelated to the mitraclips.There was no device malfunction.No additional information was provided regarding this issue.

• 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: 17916568
• Report Number: 2135147-2023-04467
• Device Sequence Number: 2982528
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: 01/10/2022
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10108U275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 92 KG