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

Model Number PED-250-14

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/28/2020

Event Type  malfunction  

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 during delivery and had resistance during resheathing with the phenom catheter.A second phenom catheter had resistance retrieving a second pipeline delivery system.The patient was undergoing a procedure for flow diversion to treat a ruptured amorphous aneurysm of the anterior communicating artery.The aneurysm max diameter was 5mm and the neck diameter was 2.4mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered but pru level was not assessed prior to the procedure.A2 on left was accessed and ped-250-14 was prepared per the instructions for use (ifu).The pipeline was positioned and started to deploy.The surgeon wanted to recapture the device and met resistance with the phenom catheter.As the surgeon pulled on the pipeline hypotube it was observed that the tip coil of the pipeline gone partially inside of the pipeline.The surgeon then decided to deploy the device instead but the tip coil went further into the pipeline device.The entire system was removed.The phenom catheter had the pipeline pushwire locked into it.To confirm the pipeline was not in the patient in any unwanted location the surgeon checked the guide catheter and the phenom for the pipeline.A 5f diagnostic catheter was inserted into the guide catheter and the pipeline pushed out from the distal end.During the case it was noted that a distal branch had a small occlusion and was treated with ia integrillin.This branch was open by the end of the procedure with slow flow but no patient injury was recorded or mentioned by the surgeon other than the mention of integrillin adminisitration for the occlusion.The procedure continued after the integrillin and a second device was attempted.The surgeon went with a new guide catheter, phenom microcatheter and a pipeline (ped-250-16) device.This device met a little bit of resistance when attempting to recapture to push the sleeves off of the distal end.However, the surgeon noted that it had not been necessary to do that in this case, but was done out of habit and some resistance was felt.The tip coil did not invert into the device like the previous and the remainder of the deployment was smooth with no problems noted.Post-operative angiography was unremarkable.Additional information received clarified that the pipeline was having difficulty during resheathing, so it was pulled out as a system.While the wire was being pulled back it was noticed that the tip of the wire was inside the partially deployed device, but the device was still attached to the proximal end of the wire.The entire system was pulled back on and the pipeline was seen to shift, as confirmed on fluoroscopy.After removing the pipeline, phenom and guide catheter from the patient, the pipeline was not found to be inside the phenom when they pushed on the push wire.To ensure the pipeline was not inside the patient physician placed a selective catheter into the guide and the pipeline pushed out from the distal tip of the guide catheter.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex embolization device (model: ped-250-14 lot: b038427) found that there were no bends or kinks with the pushwire.The distal hypotube and ptfe were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact but damaged.The tip coil was found to be damaged.Due to the condition in which the braid was returned the distal and proximal ends could not be determined.Both ends of the pipeline flex braid were found fully opened and frayed.No other damages or anomalies were found with the device.Based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed as tip coil was found to be damaged.Based on the device analysis and reported information, the customer¿s report of ¿resistance during retrieval¿ was confirmed.Both ends of the pipeline flex braid were found to be frayed which are indicative of resistance within catheter.It is likely the damage occurred when the customer attempted to retrieve the pipeline flex through the phenom catheter against the reported resistance.Pos sible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery.Based on the returned devices, there was no non-conformance to specifications identified that led to the resistance during delivery issues.H6: method code updated to b01.Result code updated to c0702 and c070601.Conclusion code updated to d15.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: 11234876
• MDR Text Key: 228852277
• Report Number: 2029214-2021-00103
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536014404
• UDI-Public: 00847536014404
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: PED-250-14
• Device Catalogue Number: PED-250-14
• Device Lot Number: B038427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 80