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

Model Number PED-400-20

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline pushwire separated during deployment.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery with a max diameter of 7.88mm and a 3.55mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, but the specific pru level was unknown.It was reported that during delivery of the pipeline, the stent's tip opened well, the physician pulled back for positioning, and everything went smoothly.However, in the process of continuing deployment of the stent, it was found that the pushing rod was pushed to the distal side, but the stent was not deployed.The surgeon tried to retrieve and found there was no way to retrieve the stent.It was thought the pushwire might have separated.The stent was then withdrawn carefully together with the marksman microcatheter.It was stated there was friction/difficulty with both the pushing and withdrawal process, but clarified the statement was referring to the stent's non-response to the pushwire.A new marksman and pipeline were then used, and the procedure was completed smoothly.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed no problems.Ancillary devices include a cook 6f, navien 6f 115, marksman, transend ex, microplex 10 5mm/15cm helical 10 regular;microplex 10 4mm/10cm helical 10 regular.

Manufacturer Narrative

There was no pipeline flex braid returned with the pushwire.The pipeline pushwire was returned inside the marksman catheter and tip coil and sleeves were partially deployed from catheter distal tip.For further examination, the pipeline flex was then pushed out from the catheter lumen with no issues.When compared to the drawings the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub, lumen and tip with no issues.No other anomalies were observed.Based on the analysis findings, the pipeline flex was not confirmed to have ¿pushwire break/separation¿.The root cause could not be determined as no damages were found with the pipeline flex pushwire and catheter.The pipeline flex appeared to be intact and no separation was found.There was no device malfunction or non-conformance to specifications identified that led to the reported issue.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10483721
• MDR Text Key: 207188800
• Report Number: 2029214-2020-00876
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A990194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR