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

Model Number PED-450-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Muscle Weakness (1967); Stenosis (2263)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline that was damaged at the distal end and then detached within the phenom microcatheter during retrieval.The patient was being treated with flow diversion for an unruptured saccular aneurysm of a paraophthalmic artery.The aneurysm max diameter was 8mm and the neck diameter was 6mm.Patient vessel tortuosity was moderate.It was reported that the devices were prepared and the catheter flushed per the instructions for use (ifu).The microcatheter was navigated to the m1.The pipeline stent was being deployed using the drag and drop technique.When going through the bifurcation into the interior carotid artery (ica) the pipeline came out too quickly and was too close to the distal neck of the aneurysm.The surgeon resheathed the stent and navigated back to the middle cerebral artery (mca) to reattempt stent deployment.However, during the second attempt, the distal tip of the stent had a folded shape as if it had folded over on itself.Upon advisement from the manufacturer representative (rep) the surgeon resheathed the stent to remove and replace.When retrieving the stent back through the microcatheter, the stent detached from the pushwire and was stuck within the catheter so the system was all removed together.After removal, it was noted that the pipeline ptfe sleeves were missing from the deployment wire.Nothing could be seen remaining in the patient on angio.A second pipeline was deployed successfully with good vessel wall apposition.On day two post-op, stenosis in the implanted stent was noted.The surgeon successfully retrieved the clot.On day three, the patient's status was improving with only slight weakness remaining.The patient was treated with standard dual antiplatelet treatment (dapt).The surgeon did not believe the stenosis was related to the issues with the first stent.

Manufacturer Narrative

D4.Suspect medical device - similar device brand name = pipeline flex w/shield technology, model # = ped2-450-10.H2: type of follow up - correction.Upon further review, there was not any device malfunction reported with this pipeline flex with shield device.This was second device used in the procedure and deployed successfully with good vessel wall apposition.This device is not marketed or commercially distributed in the us, though it is similar to one that is.Since there was no malfunction, this does not meet the criteria for a reportable 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: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10264838
• MDR Text Key: 203100295
• Report Number: 2029214-2020-00685
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284497
• UDI-Public: 00763000284497
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2021
• Device Model Number: PED-450-10
• Device Catalogue Number: PED2-450-10
• Device Lot Number: A999435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention