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

Model Number PED-350-30

Device Problem Activation Failure (3270)

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

Event Date 06/30/2020

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 embolization device failed to open in the distal section.It was reported that when the pipeline was attempted to be deployed at the predetermined location it would not open in the distal section.The physician waited more than 10 minutes as according to the instructions and retrieved and re-deployed more than 2 times, but the pipeline still could not be opened.More than 50% had been deployed when it failed to open, and the device was not positioned in a bend.The pipeline was removed with the microcatheter and was replaced.The patient did not experience any injury or complications.The angiographic results post procedure showed that the blood flow diversion effect was satisfactory.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the posterior communicating artery.The max diameter was 10.18 mm.The neck diameter was 6.22 mm.The patient¿s vessel tortuosity was moderate.Ancillary devices include a marksman microcatheter and a navien catheter.

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

No additional information received.

Manufacturer Narrative

H3: the pipeline flex embolization device (model: ped-350-30 lot: a794038) and marksman catheter (model: fa-55150-1030 lot: 218286975) were returned for analysis.However, no complaint was made against the marksman catheter.Upon visual inspection, no damages were found with the marksman hub or distal tip; however, the pipeline flex pushwire was found extending ~48.0cm from the marksman catheter hub and ~1.6cm.The marksman catheter body was found to be accordioned at ~28.4cm for ~4.5cm from distal tip.No damages were found with the distal tip.The marksman total length was measured to be ~156.9cm.The marksman useable length was measured to be ~149.3cm which is within specification (specification: 150.0cm ± 3cm).The pipeline flex delivery system was then removed from the marksman catheter.The marksman micro catheter could not be used for resistance testing with an in-house guidewire due to its damaged condition.The pipeline flex pushwire was found to be bent at ~116.6cm from proximal end.The distal hypotube was found to be intact with the ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found intact and not damaged.The tip coil was found to be intact.Due to the returned condition of the braid, the proximal and distal ends were unable to be determined.The pipeline flex braid ends were found collapsed and frayed.The distal end of the pipeline flex braid was found to be collapsed.The catheter was destroyed during removal of the pipeline delivery system.No device malfunction was reported for the marksman catheter.No resistance was encountered when removing the pipeline delivery system from the marksman catheter during analysis.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as both one end of the pipeline flex braid was found to be collapsed and both ends were found to be frayed.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10221917
• MDR Text Key: 198133228
• Report Number: 2029214-2020-00642
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015456
• UDI-Public: 00847536015456
• Combination Product (y/n): N
• PMA/PMN Number: P100018
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: PED-350-30
• Device Catalogue Number: PED-350-30
• Device Lot Number: A794038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 45