MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED2-325-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bacterial Infection (1735); Hemorrhage/Blood Loss/Bleeding (1888); Skin Discoloration (2074); Vascular Dissection (3160)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a patient treated with 2 ped2 pipelines had complications.Source document reported the following findings on the day of index hospital discharge: hematuria and positive test for uti.Antibiotic was given - rash on abdomen and back possibly due to drug reaction.Steroid cream was prescribed - femoral dissection: possibly access site, conservative follow up atrial fibrillation which was resolved and medication was not prescribed at this moment due to risk of hemorrhage.Planned to wait for 2 weeks after stroke event on (b)(6) 2024.No other information was received.
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
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
Additional information received reported that there ll aes now reported by the site.Uti: hematuria and leukocytosis.Rash was reported to be due to antibiotic for uti.No action was taken for rash.Femoral access site injury was assessed to be probably related to the staged procedure.Conservative approach for femoral access site injury.Two events of uti.First on (b)(6) 2024, treated by zosyn.Second uti started on (b)(6) 2024 and treated by nitrofurantoin.Rsh (mobiliform drug eruption) was started on (b)(6) 2024 and assessed as related to zosyn.No action was taken since zosyn was already discontinued.Agitated delirium started on (b)(6) 2024 and treated by trazodone nightly and encouragement of normal wake-sleep cycle.Minor femoral access site injury started on (b)(6) 2024 and was assessed as related to staged procedure.Conservative approach.Atrial fibrillation was not reported by the site as an ae.Per site, a fib is a pre-existing medical condition.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19085666
• Report Number: 2029214-2024-00633
• Device Sequence Number: 15239030
• Product Code: OUT
• UDI-Device Identifier: 00763000284053
• UDI-Public: 00763000284053
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• 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
• Report Date (Section B): 05/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B281716
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/08/2024
• Date Device Manufactured: 10/14/2021
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 92 KG