MAUDE Adverse Event Report: PERFUSION SYSTEMS PENDITURE LAA EXCLUSION SYSTEM; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	LAAC40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information through the clip-it clinical post-market study, that following a procedure involving use of the penditure clip on (b)(6) 2025, the customer reported that the patient had atrial fibrillation on (b)(6) 2025, and it was treated with concomitant medication administered or adjusted due to this adverse event (ae).The medication was given intravenously.The ae resulted in the prolongation of an existing hospitalization for the subject.K shoulders had helped as well.The patient stated that they did not feel like they could move around sufficiently but their arms and legs worked sufficiently.The patient went into atrial fibrillation rapid ventricular response last night with their heart rate approximately 170 bpm.They were started on amio protocol and did convert back to normal sinus rhythm (nsr).They remained in nsr with their heart rate at approximately 60 bpm.The outcome of the adverse event is recovering/resolving, and the patient has been hospitalized since (b)(6) 2025.The adverse event was deemed by the investigator as casually related to the penditure clip device, but not related to the penditure delivery system.The adverse event was deemed by the sponsor as possibly related to the penditure clip device, but not related to the penditure delivery system.Medtronic received additional information that the site updated the device relationship to clip and delivery system as not related.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PENDITURE LAA EXCLUSION SYSTEM
• Common Device Name: LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21761463
• Report Number: 2184009-2025-00484
• Device Sequence Number: 8758883
• Product Code: PZX
• UDI-Device Identifier: 00763000791452
• UDI-Public: 00763000791452
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K232295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/03/2025

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: 12/12/2025
• Device Model Number: LAAC40
• Device Catalogue Number: LAAC40
• Device Lot Number: T4M023X
• 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: 03/11/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 12/12/2024
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White