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

Model Number PED2-400-12

Device Problems Positioning Failure (1158); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Medtronic received a report that upon obtaining access into the right ica with a triaxial approach of the phenom 27 microcatheter in the right mca, the phenom plus positioned distally to the horizontal petrus and the 7fr rist at the level of the horizontal petrus (right ica), the pipeline shield was prepped per fda instructions and delivered into the phenom 27 microcatheter with moderate tortuosity.The pipeline was slightly opened in the right mca then dragged into position of the right supraclinoid aneurysm just distal to the right pcomm but during delivery the pipeline slipped out of position.The physician correctly tried to resheath the pipeline to reposition more distally but the pipeline came off the distal bumper and they lost control of resheathing the pipeline and with about 60% of the pipeline still inside the phenom 27, they were able to completely remove the pipeline by removing the phenom 27 with no complications to the patient.A new phenom 27 and pipeline were prepped per fda instructions with the same scenario as before occurring, the pipeline mispositioned over the aneurysm and the pipeline came off the bumper while attempting to resheath.A third phenom 27 and pipeline were used with no complications and the procedure was successfully completed.The pipeline was not used off-label and was prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.A dapt (dual antiplatelet treatment) was administered and the pru level was 130.The angiographic result post procedure showed good result.The patient was undergoing surgery for treatment of a amorphous, unruptured aneurysm in the right supraclinoid ica with a max diameter of 5mm and a 3mm neck diameter.It was noted the patient's vessel tortuosity was moderate.

Manufacturer Narrative

Associated regulatory report: 2029214-2022-00949.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: 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: 14606022
• MDR Text Key: 301096391
• Report Number: 2029214-2022-00950
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284329
• UDI-Public: 00763000284329
• 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
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-400-12
• Device Catalogue Number: PED2-400-12
• Device Lot Number: B267082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Date Device Manufactured: 09/17/2021
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 96 KG