MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number	CDS0601-NTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This will be filed to report a single leaflet device attachment (slda) and worsening mitral regurgitation.It was reported that on (b)(6) 2019, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4.Two mitraclip ntr were implanted without issue, reducing to grade 1.On (b)(6) 2023, the patient returned to the hospital and transesophageal echocardiogram (tee) showed one of the implanted clips had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4+.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: on (b)(6) 2023, the patient presented to the hospital with shortness of breath and fatigue.
Additional Manufacturer Narrative
The device was not returned for analysis.As it could not be determined which of the two ntr clips detached and resulted in slda, a review of the lot history records for both the ntr lots associated was performed and identified no manufacturing nonconformities issued to the reported lots that would have contributed to the reported event.Additionally, a review of the complaint history for both the lots identified no similar complaints from the lots.All information was investigated and based on the information provided, a cause for the reported slda could not be determined.Mitral valve insufficiency/regurgitation (mr) resulting in dyspnea (shortness of breath) and fatigue appears to be related to patient/procedural conditions.Dyspnea, fatigue and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• 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: 16611874
• Report Number: 2135147-2023-01338
• Device Sequence Number: 20111239
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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: IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female