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 Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This will be filed to report a single leaflet device attachment and recurrent mitral regurgitation it was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+ with a prolapsed anterior leaflet.Two clips were successfully implanted, and the procedure was concluded with a resulting mr of grade 1+.On (b)(6) 2023 a transthoracic echocardiogram (tte) was performed and 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.
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 incidents reported from this lot.Based on available information, the reported mitral valve insufficiency/ regurgitation (recurrent mr) was due to the single leaflet device attachment (slda).The cause of the reported incomplete coaptation (postprocedure) associated with the slda could not be determined.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: 16763765
• Report Number: 2135147-2023-01692
• Device Sequence Number: 20345370
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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: 08/30/2023
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 20830R165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: Asian