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	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a penditure laa exclusion system, the device moved after suboptimal device placement; the surgeon used an inferior approach to access and place the device onto the appendage and it looked like a good placement.The curved tip was pointing toward the atrium.Then the rest of the procedure took place.At the end of the procedure, the anesthesiologist saw flow and asked the surgeon if the clip was deployed.When checking the echo, they noticed that the clip had slipped about halfway down the appendage.The surgeon recaptured the device and placed it again in an appropriate manner.The clip moved again (it was placed in one area, and it ended up in another place).The surgeon asked for, and placed, a competitor¿s clip (using the same size) with no issues.The surgeon commented that the procedure was a redo and that the patient had pericarditis, which may have affected the performance of the clip.The estimated total number of actuations was 3 times and recapture 1 time.A sizer was used to determine the correct size of the device.The device was replaced prior to closure of the patient.It was reported that the operating room time was increased by about 5 total minutes due to the device issue.There was no adverse patient effect associated with this event.Medtronic received additional information that the issue was identified during the case.When the customer performed the echo, the patient was not closed up.The customer used the sizer to select the device type.The curved tip was pointing toward the atrium.At the end of the procedure, the anesthesiologist saw flow and asked the surgeon if the clip was deployed.They then went back in and re-deployed the device.It was noted that there may not have been enough tissue in the device, based on location and patient anatomy.It was also noted that there may have been resistance when pulling back the handle if the clip was not fully deployed.There is a potential this was an incomplete deployment, per the customer.Different size clips were not used.The device was replaced with a competitor's device of the same size.It was asked but unknown whether the anatomy of the appendage was abnormal.
Additional Manufacturer Narrative
Device evaluation: visual inspection showed no outward signs of any damage/assembly errors.The device was cleaned using a 10% bleach solution.The jaws were observed under magnification with no issues noted.Clamp force testing was performed which was within specifications.Reason for return was not confirmed.This regulatory report is being submitted due to retrospective review through capa 624392.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: 21262890
• Report Number: 2184009-2025-00071
• Device Sequence Number: 4604109
• Product Code: PZX
• UDI-Device Identifier: 00763000791476
• UDI-Public: 00763000791476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/29/2025

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: 10/18/2024
• Device Model Number: LAAC50
• Device Catalogue Number: LAAC50
• Device Lot Number: T3K059X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White