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

Model Number PED2-500-25

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

Medtronic received information that ped2 pipeline was stuck in the distal section of the catheter during delivery, failed to open in the distal sections, and was damaged.The patient was being treated for a saccular, unruptured aneurysm close to the ophthalmic region.The distal landing zone was 4.5mm and the proximal landing zone was 5.3mm.Vessel tortuosity was severe.Dual antiplatelet therapy was  not administered.The pipeline was not used for an indication that was not approved.The devices were not prepared as indicated in the instructions for use (ifu).  the stent could not be released because it didn't exit the microcatheter.With a very difficult anatomy, the doctor decided to remove all items from the patient.After the procedure, the doctor verified that the stent was damaged.This could be because the clinician inverted the pipeline ptfe sleeve before placing it on the microcatheter.The anatomy was very tortuous and resistance was already expected to release the pipeline.Unfortunately, it was not possible to liberate the stent from inside the microcatheter.The catheter was continuously flushed with heparinized saline.The physician released the load in the system in an attempt to resolve the issue.The issue did not resolve.The catheter and push wire were not damaged.The distal section of the pipeline was positioned in a bend.The pipeline was not stuck in a capture coil.Less than 50% had been deployed when it failed to open.The pipeline had ben resheathed less than or equal to 2 times.No additional steps were done to open the pipeline.The pipeline was resheathed and removed with the microcatheter.The pipeline also had movement during placement/difficult placement and positioning.Multiple pipelines were not being used. there was severe friction or difficulty during delivery and positioning.The pipeline was not implanted at the intended location.It did not miss the landing zone or jump during deployment.It was placed at least 3mm past the aneurysm neck on each side.No side branches were coved by the pipeline.The catheter tip did not move during deployment.No additional medical or surgical interventions were done.No symptoms were reported. it was not possible to treat the aneurysm, so the patient continues with the same initial condition.Ancillary devices: excelsior xt-27 microcatheter.

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.

• 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: 14079425
• MDR Text Key: 298613414
• Report Number: 2029214-2022-00611
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B271439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Date Device Manufactured: 09/24/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 57 KG