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

Model Number	LAAC45
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a penditure clip device, at the end of the procedure, prior to coming off bypass, the customer measured and placed the penditure device across the left atrial appendage.The customer noted that it was difficult to observe the entire appendage.The customer asked the perfusion to fill the heart and for the anesthesiologist to verify that they had complete closure of the left artrial appendage (laa) on the transesophageal echocardiogram (tee).The anesthesiologist noted that there was a small area distally that had blood flow and suggested to them to recapture and redeploy the device.The customer tried to recapture the device by inserting a long prong of the handle into the clip that was attached to the appendage.They stated that the prong was stuck in the clip and would not allow him to advance or pull out.The customer continued to manipulate the handle with the prong stuck and noted that bleeding was coming from appendage.They requested for a competitive clip to be opened and placed the competitive device across the appendage.The tee revealed that there was still a small amount of blood flow across the appendage.There was no adverse patient effect associated with this event.Medtronic received additional information that the patient is doing well and there were no complications.Medtronic received additional information that they do not have the delivery system.There were two pins in the system.They did not get the small pin to go back into the clip.They used a sizer device.The approach was through sternotomy.The concomitant procedure was a mitral valve regurgitation (mvr) procedure.They did not remove the laa from the patient.It was the doctors 2nd case experienced with the device.It could possibly be the way the user was pushing the buttons.Medtronic received additional information that the laa was of normal size.The patient was thin and had a narrow chest.The surgeon was struggling to observe the appendage making application challenging.
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: 21414590
• Report Number: 2184009-2025-00280
• Device Sequence Number: 20963189
• Product Code: PZX
• UDI-Device Identifier: 00763000791469
• UDI-Public: 00763000791469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232295
• 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): 02/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: LAAC45
• Device Catalogue Number: LAAC45
• Device Lot Number: T4C097X
• 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: 01/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 03/21/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Unknown