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

Model Number PED-450-18

Device Problems Retraction Problem (1536); Material Separation (1562); Activation Failure (3270)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id fg15150-0615-1s (lot: 227122907); product type: ; implant date n/a; explant date n/a 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

Medtronic received a report that the pipeline fish-mouthed and encounterd resistance in the phenom catheter.The patient was undergoing dense mesh stent implantation for treatment of a saccular, unruptured aneurysm in the left ophthalmic artery segment with a max diameter of 4.35 mm and a 4.21 mm neck diameter.Landing zone: distal: 3.86 mm and proximal: 4.37 mm.The accessed vessel was the right femoral artery with a diameter of 4.32.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet treatment was administered.The pru level was 0.The angiographic result post procedure was normal.It was reported that the ped450-18 dense mesh stent was pushed up and in place through the phenom27 microcatheter, and the stent was deployed.After the tip end of the stent was deployed, it was in the shape of a fish mouth and was not fully opened.After multiple push and pull operations, the problem still could not be solved.Then it was decided to retrieve the stent and deployed the tip end again.During the process of retrieving the stent into the microcatheter, there was obviously greater resistance.After complete retrieval, it was found that the proximal end of the stent was separated from the retrieval mark point, and the proximal end of the stent was unloaded, and the entire was withdrawn from the body.The new phenom27 microcatheter and ped-450-20 stent were replaced, and the operation was successfully completed.The pipeline was not used for an indication that was off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.

• Brand Name: PIPELINE FLEX
• 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: 18901939
• MDR Text Key: 337631499
• Report Number: 2029214-2024-00434
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-18
• Device Catalogue Number: PED-450-18
• Device Lot Number: B584611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 06/23/2023
• 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
• Treatment: SEE H11...
• Patient Age: 42 YR
• Patient Sex: Male