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

Model Number	LAAC50
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a penditure device, the customer reported a leak at the u portion of the clip.The left atrial appendage (laa) clip leaked and migrated around.The customer claims that the larger clips may not have enough closure force.The customer put a pledgeted suture to control the leak after cutting the appendage to test and also used the pledget to stop migration.The device was used to complete the procedure.There was no adverse patient effect associated with this event.
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
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: 20742746
• Report Number: 2184009-2024-00720
• Device Sequence Number: 15615382
• Product Code: PZX
• UDI-Device Identifier: 00763000791476
• UDI-Public: 00763000791476
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/21/2024

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: 11/22/2024
• Device Model Number: LAAC50
• Device Catalogue Number: LAAC50
• Device Lot Number: T3L025X
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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 Age: 63 YR
• Patient Sex: Male