MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; CATHETER, STEERABLE

Model Number	SGC0701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/02/2025
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 a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and prolapsed leaflets.Following transseptal puncture, a mitraclip xtw was inserted and deployed on the mitral valve.A second mitraclip xtw was then inserted.However, a pericardial effusion was observed.To treat the pericardial effusion, pericardiocentesis was performed, and the patient was stabilized.The second clip was deployed on the mitral valve, reducing mr to trace.In the physician¿s opinion, the pericardial effusion was due to the transseptal puncture.There were no device issues.There was no clinically significant delay in the procedure.The patient was reported to be discharged.
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.The investigation determined the reported pericardial effusion appears to be related to procedural conditions.Pericardial effusion is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance as pericardiocentesis was performed to treat the pericardial effusion.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 and prolapsed leaflets.Following transseptal puncture, a mitraclip xtw was inserted and deployed on the mitral valve.A second mitraclip xtw was then inserted.However, a pericardial effusion was observed.To treat the pericardial effusion, pericardiocentesis was performed, and the patient was stabilized.The second clip was deployed on the mitral valve, reducing mr to trace.In the physician¿s opinion, the pericardial effusion was due to the transseptal puncture.There were no device issues.There was no clinically significant delay in the procedure.The patient was reported to be discharged.

• Brand Name: MITRACLIP
• Common Device Name: CATHETER, STEERABLE
• 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: 23890738
• Report Number: 2135147-2025-07722
• Device Sequence Number: 18475017
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)260901(10)50304R1040
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/10/2026

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: 09/01/2026
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 50304R1040
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female