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 Code	Insufficient Information (4580)
Date of Event	02/25/2022
Type of Reportable Event	Death
Event or Problem Description
This report is being conservatively filed to report the death.Crd_1002 - expand g4 phase 1 and phase 2 study: patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) grade 4+ with a posterior leaflet prolapse, mitral annular calcification.One mitraclip was successfully implanted, reducing the mr to grade 2+.On (b)(6) 2022, the patient had been hospitalized with hypoxia.On (b)(6) 2022, the patient passed away due to a cardiovascular related death.Per physician, the event was unknown if device related.Three attempts were made to obtain information without success.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.The investigation was unable to determine a cause for the reported death.Death is listed in the instructions for use as a known possible complication 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
• 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: 17208270
• Report Number: 2135147-2023-02793
• Device Sequence Number: 6591763
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/27/2023

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: 07/29/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10730R155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 66 KG