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	Unspecified Heart Problem (4454)
Date of Event	01/10/2022
Type of Reportable Event	Death
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with severe mitral regurgitation (mr).One mitraclip (cds0701xtw, 10416r106) was implanted without an issue reported, reducing the mr to approximately grade 1+.On the discharge echocardiogram, the mr was noted at moderate to severe.The patient remained stable, without complaints.Reportedly, the patient was doing well and in stable condition.Per history and physical dated (b)(6) 2021, the patients symptoms had not improved following the index procedure.Per imaging, there might have been a tear in the valve.On (b)(6) 2021, the patient presented with recurrent, severe mr.Another mitraclip (cds0701-nt 10227r117) was implanted medial to the previously implanted clip, reducing the mr to grade 1+.There was no device deficiency.Note-the recurrent mr noted on discharge and second clip procedure are captured and reported in another event/complaint (b)(4).Initial mdr 2024168-2021-07102-00 and follow-up mdr 2024168-2021-07102-01 will be sent.On (b)(6) 2022, the patient passed away while at home.Reportedly, the death was of cardiovascular origin, and unknown if device related.Per account, additional details were unable to be obtained.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 patient death was unable to be determined.The reported patient effect of death, 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.The additional mitraclip device is captured and reported in another event/complaint (b)(4).Initial mdr 2024168-2021-07102-00 and follow-up mdr 2024168-2021-07102-01 will be sent.

• 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: 16521947
• Report Number: 2135147-2023-01117
• Device Sequence Number: 16747882
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/10/2023

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: 02/26/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10227R117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2021
• 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: Death
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG