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

Model Number PED-450-35

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

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

See related regulatory report 2029214-2020-01230.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline opened well distally when ready for deployment, but failed to open on the distal end as deployment continued.2 resheathing attempts were made but the issue persisted.As a result the device was removed and replaced, with the same issue of failure to open on the proximal end occurring on the replacement pipeline device.There were no additional attempts made to deploy the pipelines.It was also stated that there was difficulty deploying the pipeline devices through the phenom microcatheter due to resistance in the middle section.Another replacement device was used successfully and without issue.The patient was undergoing treatment of an unruptured right ica cavernous segment aneurysm with a max diameter of 4.75mm and a neck diameter of 8mm.The devices were prepared as indicated per the ifu.There were no related patient symptoms.Post angiographic results showed aneurysm stasis.It was noted that the patient's vessel tortuosity was moderate.

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 from the physician noted that there was no damage seen on the devices, and the pipeline was not placed in a vessel bend when it failed to open.

Manufacturer Narrative

H3: two pipeline flex devices (model: ped-500-30 lot: a734619) (model: ped-450-35 lot: a881406) were returned for analysis.The two braids were already deployed.The phenom-27 micro catheter (model: fg15150-0615-1s lot: oc19-077) used in the event was returned separately.Pli-20 (model: ped-450-35 lot: a881406) no damages were found with the proximal pipeline flex pusher.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 intact and unstretched 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 slightly stretched.The already deployed braid was found fully opened on both ends with the ends frayed and damaged.No other damages or anomalies were observed.Pli-30 (model: fg15150-0615-1s lot: oc19-077) the phenom-27 total length was measured to be ~159.0cm, the usable length was measured to be ~152.7cm and the distal single coil length was measured to be ~14.6cm; which is within specification.No flash or voids molded were found with the catheter hub.No damages or irregularities were found with the catheter hub, catheter body, distal tip or marker band.The inner diameter of the phenom-27 was measured to be 0.0270¿ proximally and 0.0265¿ distally and found to be within specification.A 0.0265¿ mandrel was then inserted into the phenom-27 catheter hub, through the catheter body and out the distal tip with no resistance encountered.No other damages or anomalies were observed.Based on the device analysis, the customer report of ¿resistance/stuck during delivery¿ and ¿catheter resistance¿ could not be confirmed.No resistance was encountered with the catheter during in-house resistance testing and the two returned pipeline flex braids were returned already deployed and could not be tested.Possible causes for resistance are frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, or user pulls back on/torques wire while advancing ped in micro catheter.Customer reported device were prepared per ifu patient vessel tortuosity was moderate, no damages were seen on the devices and pipeline was not placed in a vessel bend.The customer report of ¿failure/incomplete open proximal (flex)¿ could not be confirmed as the braid was returned fully opened.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.The braids were both found frayed/damaged and one braid was found flattened.As the braid was returned already deployed and not within its protective introducer sheath, the cause of the damage could not be determined.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: 10943264
• MDR Text Key: 219523880
• Report Number: 2029214-2020-01231
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016569
• UDI-Public: 00847536016569
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: PED-450-35
• Device Catalogue Number: PED-450-35
• Device Lot Number: A881406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 02/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1