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	Atrial Fibrillation (1729)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery the penditure clip, a transesophageal echocardiogram (tee) was performed several days later and it was observed that the clip had slipped off, resulting in a 2cm residual stump.Medtronic received additional information that the concomitant procedure was an aortic valve replacement (avr), in combination with coronary artery bypass graft (cabg) x3.The clip was not deployed on a beating heart.A sizer was used to determine the clip size.The implant technique was full sternotomy and the site of insertion was an arrested heart.There was nothing unusual about the appendage.The patient returned to the hospital with rapid atrial fibrillation.A pre-cardioversion tee showed a 2cm residual left atrial appendage (laa).Anticoagulation will have to be continued.
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.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed the customer had provided a cd with the patient data.The reason for the complaint was undetermined.Correction b5: it was reported that after a surgery in which the penditure clip was used, a transesophageal echocardiogram (tee) was performed several days later and it was observed that the clip had slipped off, resulting in a 2cm residual stump.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.
Additional Manufacturer Narrative
Correction b5: medtronic received additional information that the transesophageal echocardiogram demonstrated flow into the left atr ial appendage after the left atrial appendage ligation clip was placed.At the time of insertion, the clip was placed and there was no flow into the left atrial appendage.There was no issue with the placement of the device.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: 22883433
• Report Number: 2184009-2025-01006
• Device Sequence Number: 15854230
• Product Code: PZX
• UDI-Device Identifier: 00763000791469
• UDI-Public: (01)00763000791469(17)250921(10)T4J029X(20)01
• 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,Followup,Followup
• Report Date (Section B): 01/13/2026

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: 09/21/2025
• Device Model Number: LAAC45
• Device Catalogue Number: LAAC45
• Device Lot Number: T4J029X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 01/09/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/06/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male