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

Model Number	LAAC50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/01/2024
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.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
Medtronic received information through the clip-it clinical post-market study, that following a procedure involving use of the penditure clip on (b)(6) 2024, the customer reported that the patient had a complete heart block.The patient was presenting with asymptomatic complete heart block with junctional escape rhythm.They were admitted on (b)(6) 2024 for a permanent pacemaker (ppm) implant.They were subject to a new hospitalization.On (b)(6) 2024, they were successfully treated with an implantable cardiac rhythm device.The adverse event was deemed by the site as not related to the penditure delivery system device.The adverse event was deemed by the sponsor as possibly related to the clip and as not related to the penditure delivery system device.The end date of the hospitalization was on (b)(6) 2024.The outcome of the adverse event is recovering/resolving with sequelae.Medtronic received additional information that the implant procedure required the administration of iv antibiotics for prophylaxis purposes.
Additional Manufacturer Narrative
Additional info b5: medtronic received additional information that the sponsor has deemed the adverse event as not related to the penditure clip or delivery system.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
Medtronic received information through the clip-it clinical post-market study, that following a procedure involving use of the penditure clip on (b)(6) 2024, the customer reported that the patient had a complete heart block.The patient was presenting with asymptomatic complete heart block with junctional escape rhythm.They were admitted on (b)(6) 2024 for a permanent pacemaker (ppm) implant.They were subject to a new hospitalization.On (b)(6) 2024, they were successfully treated with an implantable cardiac rhythm device.The adverse event was deemed by the site as not related to the penditure delivery system device.The adverse event was deemed by the sponsor as possibly related to the clip and as not related to the penditure delivery system device.The end date of the hospitalization was (b)(6) 2024.The outcome of the adverse event is recovering/resolving with sequelae.Medtronic received additional information that the implant procedure required the administration of iv antibiotics for prophylaxis purposes.Medtronic received additional information that the sponsor has deemed the adverse event as not related to the penditure clip or delivery system.
Additional Manufacturer Narrative
Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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: 20556001
• Report Number: 2184009-2024-00664
• Device Sequence Number: 16944159
• Product Code: PZX
• UDI-Device Identifier: 00763000791476
• UDI-Public: 00763000791476
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2024
• Device Model Number: LAAC50
• Device Catalogue Number: LAAC50
• Device Lot Number: T3M197X
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 02/11/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/23/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White