MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-500-20

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

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 stent that failed to open at the distal end and then became stuck in the microcatheter.The patient was being treated for an unruptured saccular aneurysm of the clinoid segment of the left internal carotid artery.The aneurysm max diameter was 5.88mm and the neck diameter was 5.11mm.Vessel tortuosity was minimal.The patient had multiple aneurysms in the same vessel.It was reported that the microcatheter and pipeline stent were navigated smoothly to aneurysm location.The stent was deployed but the distal end failed to open.The stent was resheathed and redeployed no more than twice but the distal end still did not open so the stent had to be withdrawn.However, during withdrawal, the stent became stuck in the microcatheter so both devices were withdrawn together.The pipeline was replaced to completed the procedure.There was no harm or injury to the patient.Post-procedure angiography revealed no abnormality.

Manufacturer Narrative

H3: the pipeline flex (model: ped-500-20 lot: a990053) and phenom-27 micro catheter (model: fg15150-0615-1s lot: nv19-042) were returned for analysis.The phenom-27 micro catheter total length was measured to be ~158.5cm, the usable length was measured to be ~152.0cm and the distal single coil length was measured to be ~14.7cm which is within specification (specification: total (ref):156.5cm, usable: 150cm ± 5cm, distal single coil: 15cm ± 2cm) the inner diameter was measured to be 0.027¿ which is within specification and compatible for use with the pipeline flex.No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.Dried blood and the braid were found within the proximal end of the phenom-27.No damages or irregularities were found with the micro catheter body, distal tip or marker band.The micro catheter was flushed with water and water exited out from the catheter tip.The braid was found stuck within the micro catheter.A mandrel was used to attempt to push the braid out distally which failed and was then used to push the braid out proximally against high resistance.The catheter was then tested by running an in-house 0.0260¿ mandrel through microcatheter.The mandrel passed through the catheter hub, catheter body and distal tip with no resistance encountered.When compared to the drawing: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube was found stretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found intact.Once deployed out of the micro catheter, both distal and proximal ends of the pipeline flex braid were found not fully opened with dried blood found on both ends.The blood was dissolved; however, both the braid ends still did not open.Both ends were found damaged and the proximal end was found frayed.No other anomalies were observed.Based on the analysis findings, the pipeline flex and phenom-27 were confirmed to have ¿resistance during retrieval¿ and ¿catheter r esistance¿ as resistance with the braid within the micro catheter.It is likely the damages found on the braid and the dried blood contributed towards the resistance.There was no resistance found with the micro catheter using a mandrel once the braid was removed.The pipeline flex was found damaged.From the damages seen on the braid (frayed/damaged) and hypotube (stretched); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the phenom catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.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.¿ the customer report of ¿fai lure/incomplete open distal (flex)¿ was confirmed as both ends of the braid failed to open.It is likely the failure to open is caused by the damages to the braid ends.Both braid ends were damaged during the attempt to retrieve the stuck braid from within the micro catheter.Other possible causes for failure are patient vessel tortuosity, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.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.

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 reporting that the devices were prepared as described in the instructions for use (ifu).Continuous flush of the catheter was provided.There was no resistance during pipeline delivery but it was stuck in the proximal end of the catheter during retrieval.Both devices were replaced to complete the procedure.

• Brand Name: PIPELINE FLEX
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10307516
• MDR Text Key: 200879740
• Report Number: 2029214-2020-00711
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• 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,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A990053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR