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

Model Number	LAAC45
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during use of a penditure laa, it was reported that the device was not occlusive enough for the customer. the customer stated that the fa holding the appendage while they placed the clip, accidentally tore the tip of the appendage, so there was bleeding.The customer placed the clip and the bleeding continued from the appendage tear.The customer was surprised that the tear continued to bleed and they believed that the bleeding would stop from the compression force of the clip.The bleed did not stop, therefore, they repositioned the clip.The bleeding continued after redeployment.The customer stated that the clip was difficult to remove from the delivery tool.It was necessary for the customer to hold the clip in position and to create a counter force in the opposite direction of the removal of the delivery tool to get the clip off the device.They tested the removal of the clip again, off the heart, and they noticed that the same stickiness of removing the clip from the tool.There was a slight delay in procedure. the customer believed that they held the blue trigger button down the whole time while removing the clip from the tool. the device was replaced with an atricure flex v to complete the procedure and the bleeding stopped.The tip of the appendage was accidentally torn.

• 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: 19526969
• Report Number: 2184009-2024-00361
• Device Sequence Number: 15343545
• Product Code: PZX
• UDI-Device Identifier: 00763000791469
• UDI-Public: 00763000791469
• 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: 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
• Report Date (Section B): 06/13/2024

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: 11/23/2024
• Device Model Number: LAAC45
• Device Catalogue Number: LAAC45
• Device Lot Number: T3L151X
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/13/2024
• Date Device Manufactured: 11/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG