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	Angina (1710); Atrial Fibrillation (1729); Tachycardia (2095)
Date of Event	02/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This report is being filed due to chest pain and arrhythmias, requiring treatment, unknown of device related.Patient id: (b)(6).It was reported that on(b)(6) 2021, the patient presented with mixed mitral regurgitation wit leaflet tethering.Two mitraclips had been implanted, reducing the mr to grade 2+.There was no device deficiency.Starting on (b)(6) 2023, the patient expressed experiencing chest pain.On (b)(6) 2023, the patient was hospitalized for the chest pain.Per imaging, the patients heart rate was tachycardic at 130-140¿s.Supraventricular tachycardia, atrial fibrillation, with an irregular rhythm was noted.Medications and oxygen were provided as treatment.Per physician, the events are unknown if device related.There was no device malfunction reported.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 available information, the cause of the reported angina (chest pain), tachycardia and atrial fibrillation could not be determined.The reported patient effects of chest pain and cardiac arrhythmias as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical 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
• 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: 16460262
• Report Number: 2135147-2023-00925
• Device Sequence Number: 6514765
• 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,Followup
• Report Date (Section B): 03/27/2023

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: 03/12/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10313R160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG