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

Model Number	LAAC50
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a procedure involving the penditure clip, the case was a left ventricular assist device (lvad) and the clip slipped during the operation, and a huge stump was observed on echocardiogram.The clip had to be repositioned closer to the base.An echocardiogram was performed before coming off the procedure and after repositioning, which showed that the reposition looked good.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that the concomitant procedure was an lvad implantation via a sternotomy approach.The device was deployed on a beating heart.A sizer was used to determine the penditure size.The implant technique and site of insertion used was a right handed, inferior to superior approach.There was nothing unusual about the appendage, just a largely dilated left ventricle (lv).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: 22792294
• Report Number: 2184009-2025-00942
• Device Sequence Number: 15639952
• Product Code: PZX
• UDI-Device Identifier: 00763000791476
• UDI-Public: (01)00763000791476(17)280327(10)T5C095X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/05/2025

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 Model Number: LAAC50
• Device Catalogue Number: LAAC50
• Device Lot Number: T5C095X
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 03/27/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 69 KG