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); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the complaint device was not returned.Visual inspection of the released/back end of unopened device shows evidence of some flash/mold mismatch.Per the specification the maximum length of flash and mismatch is 0.010 inches.Reason for return was visually confirmed by the video provided by the customer.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 that after the use of appenditure laa, it was reported that the patient had post operative bleeding and it was deemed necessary to open the patient back up to find the source.The customer realized it was located where the holes for recapture are located on the penditure clip.The placement of the device originally was successful and the customer was satisfied.The clip was placed at approximately 2:00pm.The appendage was excluded and they continued to the next part of the procedure.The patient was returned back to the operative room at around 7:00pm.The patient's chest was reopened. see attached photos/video.The customer was going to remove the clip as they were not sure what caused the issue originally.However, the customer decided to leave the clip on. the customer observed that the proximal end of the penditure clip, where the hold for the recapture are located, was rubbing against the heart tissue and caused a hole. as a result, the hole caused a leakage of blood.The customer proceeded to place two sutures with pledgets in the location of the bleeding.The customer fixed the issue by placing the two sutures.The customer did n ot want to remove the clip as the appendage did not have blood for 5 hours and the customer did not know the state of the tissue.
Additional Manufacturer Narrative
Additional information b5.Medtronic received additional information that there was no icu bed available for a couple of hours post-op.The customer stated they had to wait in the or.Everything looked fine immediately after the case.The patient became hypertensive.There was nothing draining out of the chest tubes.The customer did another transesophageal echocardiogram (tee) and discovered a large clot.The customer decided to reopen the patient and evacuated a large amount of blood.Bleeding was observed from the ventricle by the av groove.Two holes were also observed in the av groove, which were repaired with pledgets and surgicell.The patient is doing well now.Medtronic received additional information that customer noticed no blood draining from chest drain and found a blood clot during tee post op which was blocking blood drainage.Customer reopened the chest and removed the clot to find the source which was two small lacerations where the clip holes were running against.The customer placed two pledgets over the bleeding areas and kept the clip in place.Correction h6 patient codes (ime/annex e) and h6.1 (device codes (fdd/annex a)): these fields were updated.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
Medtronic received additional information that the penditure clip was implanted as part of a coronaryartery bypass grafting procedure.The procedure was prompted by the patient presenting with ongoing chest tightness and pain radiation to the shoulder.Due to elevated troponin levels and dynamic chest pain, cardiology was consulted, and the patient was diagnosed with non-st-elevation myocardial infarction, type 1 acute myocardial infarction.The patient was placed on nitroglycerin and heparin drips, transferred to the intensive care unit (icu), and underwent a left heart catheterization (lhc) which revealed multivessel coronary artery disease.The customer reported that it appeared that the penditure clip had applied excess compressive force to the atrioventricular (av) groove, leading to erosion and subsequent hemorrhage into the posterior aspect of the heart.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: 19278039
• Report Number: 2184009-2024-00283
• Device Sequence Number: 6358370
• Product Code: PZX
• UDI-Device Identifier: 00763000791469
• UDI-Public: 00763000791469
• 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,Followup
• Report Date (Section B): 04/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2024
• Device Model Number: LAAC45
• Device Catalogue Number: LAAC45
• Device Lot Number: T3L028X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 03/17/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/22/2024; 04/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male