MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PENDITURE LAA EXCLUSION SYSTEM; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	LAAC40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
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 the patient had atrial fibrillation with rapid ventricular response with intermittent supraventricular tachycardia on (b)(6) 2024, and was successfully treated firstly with anticogualnts (start date-unknown -2021, end date- (b)(6) 2024), aspirin (start date-(b)(6) 2024, end date- ongoing) , anticoagulant (start date-(b)(6) 2024, end date- ongoing), class iii antiarrhythmics (start date-(b)(6) 2024, end date- ongoing).The patient has history of atrial fibrillation, and it worsened while inpatient following procedure.Amiodarone iv drip started.The patient had a concomitant surgical procedure of electrocardiogram on (b)(6) 2024.This resulted in atrial fibrillation with aberrant ventricular beats.This was clinically significant.Blood test caried out on (b)(6) 2024, and the result states: stat electrolytes sent -clinically significant: no.The outcome is unknown, and the patient have been hospitalized since (b)(6) 2024 the adverse event was deemed by the site as possibly related to the penditure clip device, but not related to the penditure delivery system.The adverse event was deemed by the sponsor as possibly related to the penditure clip device, but not related to the penditure delivery system.
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
Additional information b5: medtronic received additional information that the electrophysiologist was consulted.The end date of the hospitalization was (b)(6) 2024.The outcome of the adverse event is recovering/resolving.Medtronic received additional information that the adverse event was deemed by the site as not related to the penditure clip device and the penditure delivery system.The outcome of the adverse event was recovered/resolved with sequelae.Correction b5: the patient had an electrocardiogram on (b)(6) 2024.The electrocardiogram showed atrial fibrillation with aberrant ventricular beats.It was stated that this was clinically significant.A blood test was caried out on (b)(6) 2024, and the result are stat electrolytes sent.It was stated that the results were not clinically significant.The outcome of the adverse event is unknown, and the patient has been hospitalized since (b)(6) 2024.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
Additional information b5.Medtronic received additional information that the electrophysiologist was consulted.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): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20179216
• Report Number: 1219930-2024-04142
• Device Sequence Number: 8364224
• Product Code: PZX
• UDI-Device Identifier: 00763000791452
• UDI-Public: 00763000791452
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2025
• Device Model Number: LAAC40
• Device Catalogue Number: LAAC40
• Device Lot Number: T4A075X
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 03/02/2026
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/08/2024; 03/05/2026
• Date Device Manufactured: 01/09/2024
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White