MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG19120-1030-1S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Rupture (2208); Obstruction/Occlusion (2422)
Date of Event	07/29/2023
Type of Reportable Event	Death
Event or Problem Description
Medtronic received a report that the patient presented with a giant aneurysm.The physician treated it by placing two stryker coils in the aneurysm and laid a pipeline shield across the neck of the aneurysm.The patient was discharged from the hospital on aspirin and plavix.On (b)(6) 2023 the patient returned to the hospital in the emergency room with a subarachnoid hemorrhage.The patient was brought to internal radiation for imaging and found to have ruptured the previously treated aneurysm.The physician then placed two more pipeline shield devices across the neck of the aneurysm to try and stop the bleeding.On (b)(6) 2023 the patient clotted off their parent vessel where the two additional pipelines had been placed.Many attempts were made to clear the clot but they were not successful.The patient passed away on (b)(6) 2023.The pipelines were not used for an off-label use.The pipeline devices and any accessories were prepared as indicated in the instructions for use (ifu).The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery posterior communicating artery aneurysm with a max diameter of 25mm and a 10mm neck diameter.The landing zone artery size measurements were 4.5mm distally and 4.75mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered.The post procedure angiographic result showed patent flow through the parent vessel and stasis in the aneurysm ancillary devices include a bmx 96 90cm sheath, phenom plus guide catheter, phenom 27 microcatheter, aristotle 14 guidewire, and two stryker target xl 24x50 coils.Additional information was received from the manufacturer's representative stating that the patient death was thought to be related to the medtronic device or therapy.The parent artery clotted off after two additional pipeline shield devices were implanted to help stop the bleed.The patient did not receive aspirin and plavix for the second procedure of implanting the two pipeline shield devices as the patient had an active bleed.The two devices subsequently thrombosed off.The pipeline devices remained in the patient.Autopsy records will not be available.
Additional Manufacturer Narrative
Separate reports will be submitted for each device involved in this event.Refer to manufacturer's report 2029214-2023-01551 and 9614453-2023-03097 for details pertaining to the reportable related event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17664792
• Report Number: 9614453-2023-03098
• Device Sequence Number: 7124059
• Product Code: KRA
• UDI-Device Identifier: 00763000399733
• UDI-Public: 00763000399733
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/31/2023

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: 06/05/2026
• Device Model Number: FG19120-1030-1S
• Device Catalogue Number: FG19120-1030-1S
• Device Lot Number: 226677670
• 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: 08/03/2023
• Initial Report FDA Received Date: 08/31/2023
• Date Device Manufactured: 06/05/2023
• 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: Death
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 105 KG