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

Model Number PED-250-14

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

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 marksman microcatheter was placed at the target site, and the pipeline was deployed.However, it was found that after the tip was deployed 10 mm in length, it could not be opened.Repeated attempts were performed, but the stent still did not open.Another 6 mm of the stent was deployed, but the issue was still not resolved.It was decided to withdraw the entire system, and replacement products were used with no issue.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed slowed blood flow.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery with a max diameter of 5.8 mm and a 3.6 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.

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 reported that the distal section of the pipeline did not open.The pipeline had not been placed in a vessel bend when if failed to open.The pipeline had been resheathed two times, and was retrieved with the catheter.

Manufacturer Narrative

H3: analysis of the pipeline flex embolization device (model: ped-250-14 lot: a772260) and a marksman catheter (model: fa-55150-1030 lot: not 218503390) found no damages with the marksman hub; however, the pipeline flex pushwire was found extending ~46.5 cm from the distal tip.The marksman total length was measured to be ~157.4 cm (reference: (b)(4)).The marksman useable length was measured to be ~149.9 cm which is within specification (specification: 150.0cm ± 3cm).The marksman catheter body was found to be accordioned at ~28.9 cm for ~1.8 cm from distal tip.No damages were found with the distal tip.The catheter was flushed, and water exited the distal tip without issue.The pipeline flex was then removed from the marksman catheter.The marksman catheter was tested with an in-house 0.026 in mandrel.The in-house mandrel was inserted into the marksman and was able to pass through the distal tip without issue.No other anomalies were observed.No bends or kinks were found with the pipeline flex pushwire.The distal hypotube was found to be intact.The ptfe was found to be intact.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The dps restraints/sleeves appear to be in good condition.The tip coil was found intact but damaged.Due to the condition in which the braid was returned, the distal and proximal ends of braid were unable to be determined.The pipeline flex braid end 1 was found to be frayed and braid end 2 was found to be collapsed.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as the pipeline flex proximal and distal ends of braid were found to be collapsed.The customer reported re-sheathing the device more than twice.Possible causes could be vessel tortuosity or re-sheathing the device more than the recommended two times.H6: method code updated to b01.Result code updated to 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.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.

• 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: 10763719
• MDR Text Key: 215022956
• Report Number: 2029214-2020-01083
• 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,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: PED-250-14
• Device Catalogue Number: PED-250-14
• Device Lot Number: A772260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1