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 Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 13 november 2025, that the patient presented with grade 4+ degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, effusion and hypotension were noted.Anesthesia support maintained blood pressure stability.Two mitraclips were successfully implanted.The effusion subsequently worsened.Pericardiocentesis was used to resolve effusion and the patient was transferred to the intensive care unit (icu).Patient is in stable condition.According to the physician, the effusion may have occurred during transeptal puncture and/or dilation with the steerable guide catheter (sgc)/dilator.The mr was reduced to grade 2+ post procedure.There was no clinically significant delay.
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 the reported pericardial effusion or hypotension.Based on available information, the reported pericardial effusion appears to be related to procedural conditions.The reported hypotension is a cascading event of the pericardial effusion.A cause for the reported poor imaging could not be conclusively determined.The reported patient effects of pericardial effusion and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention 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
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23760351
• Report Number: 2135147-2025-07243
• Device Sequence Number: 13284591
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025(17)261125(10)50514A4005
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 12/09/2025

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 Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 50514A4005
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: 2 MITRACLIPS.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 69 KG