MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0601-XTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4+ mixed mitral regurgitation (mr), prolapsed anterior leaflet, thin and friable leaflets for a mitraclip procedure.During the procedure, two mitraclips were implanted successfully.The final mr was grade 1+.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, during in-hospital ultrasound follow-up, it was determined that single leaflet device attachment (slda) has occurred and leaflet was no longer attached to the posterior leaflet.Per the physician, slda was due to thin and friable leaflets.Mr was grade 4+ after slda.
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 single leaflet device attachment (slda) resulting in mitral valve insufficiency/regurgitation (mr) appears to be related to pre-existing patient anatomy of thin and friable leaflets.The reported patient effects of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complications associated with mitraclip procedures.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Code 4614 was removed and 4624 was added.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4+ mixed mitral regurgitation (mr), prolapsed anterior leaflet, thin and friable leaflets for a mitraclip procedure.During the procedure, two mitraclips were implanted successfully.The final mr was grade 1+.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, cardiac auscultation revealed a murmur at the mitral valve area.Echocardiography was done and it was determined that single leaflet device attachment (slda) has occurred with one of the mitraclip devices that had been implanted and mitraclip had detached from the posterior leaflet.Mr was grade 4+ after slda.It was noted that the patient required surgical procedure for valve replacement and removal of the mitraclip.It was noted that on 01 december 2025 during morning rounds, the patient was alert and in stable condition.Per the physician, the cause of the slda was determined to have been related to pre-existing patient anatomy of thin and friable leaflets.

• Brand Name: MITRACLIP
• 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: 23871226
• Report Number: 2135147-2025-07595
• Device Sequence Number: 11916893
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)260717(10)50717R1067
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2026
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 50717R1067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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: STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown