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

Model Number PED-475-20

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding four pipeline devices that failed to open.The patient was undergoing a flow diversion procedure to treat an unruptured saccular aneurysm of the cavernous segment of an internal carotid artery (icu).The aneurysm max diameter was 14mm and the neck diameter was 8mm.The patient's vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered with noted pru level of 160.It was reported that after 2 pipeline 5 x 25mm and 1 pipeline 4.75 x 30mm devices had been tried, failed to open, and removed, the physician made a fourth attempt to implant a flow diverter with a 4.75 x 20mm pipeline (model: ped-475-20, lot: a896153).The physician began to deploy the pipeline in the distal cavernous segment and the distal end of the pipeline opened successfully.More than 50% of the device was deployed but as the physician neared the proximal third of the device, a twist in the pipeline was noted about 5mm distal to the resheathing pad.The proximal and middle sections of the pipeline were positioned in a vessel bend.The device was resheathed and redeployed 3 times.The physician also attempted "wagging" and deploying in a different location, but the twist of the proximal end remained and the device could not be fully opened.Finally this pipeline was removed together with the phenom-27 microcatheter.It was indicated that all devices were prepared per the instructions for use.No pipeline was implanted.There were no patient symptoms or complications reported related to the event.Post-procedure angiography revealed no issue.The aneurysm remained unruptured and there was no evidence of damage from the devices.Ancillary devices: terumo 6f slender sheath, benchmark 071 90cm intracranial access guide catheter, sofia 5f distal access guide cat heter, synchro2 soft 200cm guidewire.

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.

Event Description

Additional information received indicated there was resistance felt with all four pipeline devices.A continuous flush had been administered during the procedure, and no other treatment was required for the patient at the time of the report.It was noted the physician may reschedule the patient with a different manufacturer.

Manufacturer Narrative

H3: the pipeline flex was returned stuck inside the phenom 27 catheter.For further examination, the pipeline flex was pushed out from the catheter lumen with difficulty.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 appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and frayed.Bends were found at 19.0cm to 31.0cm from the proximal end.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 phenom 27 catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body accordioned at 19.5cm to 30.0cm from the distal tip.In addition, the catheter body also appeared to be accordioned at 6.0cm to 23.5cm from the catheter hub.No flash or voids molded were observed in the hub.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 and tip; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex and phenom 27 catheter were confirmed to have ¿resistance during delivery¿ and ¿catheter resistance¿ issues.The returned pipeline flex was found stuck inside the phenom catheter.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the phenom 27 catheter against the reported resistance.Regarding the "failure to open" issue, the customer's complaint could not be confirmed as the distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.It is likely that the patient¿s severe vessel tortuosity and lack of continuous flush with heparinized saline may have contributed to the reported issues.There was no non-conformance to specifications identified that led to the resistance and failure to open issues.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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: 11047609
• MDR Text Key: 225565517
• Report Number: 2029214-2020-01353
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016743
• UDI-Public: 00847536016743
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: PED-475-20
• Device Catalogue Number: PED-475-20
• Device Lot Number: A896153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR