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

Model Number PED2-450-14

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems Muscle Weakness (1967); Pain (1994); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 05/04/2023

Event Type  Injury  

Event Description

Medtronic received a report that the pipeline pushwire broke.  the patient was undergoing surgery for treatment of a left internal carotid artery that was injured during tumor removal and caused a hole in the vessel.The landing zone was 3.75mm distally and 4.0mm proximally.It was noted the patient's vessel tortuosity was minimal.The angiographic result post procedure was the device was open and there was good flow.  it was reported that the fourth pipeline implanted and it ended on a bend and had difficulty pushing the phenom 027 back through it.When pushing the 027 into the device, the distal pusher wire was separated.The proximal section of the pushwire broke.The broken segment of the pushwire was removed from the patient with a snare/retrieval device.There was severe friction or difficulty during retrieval.The pipeline was implant in the patient.After deployment of the 4 devices, there was still flow through the injured vessel so the iva was sacrificed. the pipeline was used for an indication that is not approved (off-label); the artery was injured during surgery for tumor removal.The pipeline and any accessory devices were prepared as indicated in the ifu.Ancillary devices include a rist 079 sheath, phenom plus guide catheter, phenom 027 150cm microcatheter, synchro 014 and asahi.018 guidewire, medtronic and penumbra coils, ped2-400-16, ped2-425-14, and ped2-450-12.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Additional information received reported the procedure had to be done due to a complication from a different procedure removal of a tumor.¿ he's now trach'ed and peg'ed, sometimes following 1 step commands, right eye 3rd nerve palsy, left eye opens to pain, some left sided weakness.Had some bumps during hospitalization, temporarily wasn't working, etc, but generally he's stable.".

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: 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: 16894779
• MDR Text Key: 314835251
• Report Number: 2029214-2023-00770
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284510
• UDI-Public: 00763000284510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-14
• Device Catalogue Number: PED2-450-14
• Device Lot Number: B486811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male