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

Catalog Number	CDS0601-NTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/16/2023
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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported slda was due to a combination of patient anatomy and procedural circumstances.The reported unchanged mr was a cascading event of the reported slda.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
This will be filed to report a single leaflet device attachment (slda).It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with an enlarged left atrium.Shortly after deployment of the first clip, the first clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).In the treating physician's opinion, the slda was due to the patient's anatomy and insufficient leaflet grasping.It was also noted the steerable guide catheter was difficult to curve.The procedure was then concluded with 1 clip implanted and no change in mr.There was no clinically significant delay in the procedure and no additional information was provided.
Additional Manufacturer Narrative
Based on available information, the reported slda was due to a combination of patient anatomy and procedural circumstances.The observed broken l-lock tabs was likely due to post-procedural shipping/handling as no related issues were reported.The reported unchanged mr was a cascading event of the reported slda.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality 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: 17413602
• Report Number: 2135147-2023-03297
• Device Sequence Number: 15213255
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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 Expiration Date: 04/10/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30410R1030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian