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

Model Number PED2-425-16

Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)

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

Event Date 03/18/2020

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 failed to open and the pushwire broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery with a max diameter of 18mm and a 4.6mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that due to the vessel tortuosity, the distal end of the pipeline failed to open at the site of the aneurysm.Both the navien and phenom27 were pushed and pulled repeatedly about ten times in an attempt to open the pipeline, but once 1/3 of the pipeline was deployed, the proximal bumper of the pushwire near the wire weld broke suddenly.The pushwire was removed, and the entire delivery system was removed leaving the broken segment of the pushwire and the pipeline in the femoral artery.The broken segments were safely removed via kocher and the procedure was ended.Angio contrast showed there was no change from before the procedure and there was no harm to the patient.Ancillary devices include a medikit super sheath 8fr, roadmaster 8 fr, navien, phenom27, chikai14.

Manufacturer Narrative

The pipeline flex with shield braid and pushwire were returned.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 and ptfe shrink tubing were found to be intact with no signs of elongation.The pushwire appeared to be separated at the distal hypotube.The outer jacket on the hypotube appeared to be pulled back at the broken end.No bend was observed on the pushwire.The distal end of the pipeline flex with shield braid was found not opened due to damaged braid.The proximal end of the braid appeared fully opened and moderately frayed.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the analysis findings, the pipeline flex with shield was confirmed to have failure to opened at the distal end and hypotube separation issues.It is possible that the severe vessel tortuosity may have contributed to the failure to open issue.Per the scanning electron microscopy (sem)/energy dispersive spectroscopy (eds) results, most of the fracture surfaces exhibit corrosion damage.A few areas exhibit dimple features consistent with ductile overload type failure.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

H6: device code changed from c63242 to c62973.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

Per the sem/eds results, most of the fracture surfaces exhibit corrosion damage.A few areas exhibit dimple features consistent with ductile overload type failure.In addition, per the core tech results: "flat, appears brittle, corrosion on fracture surface.".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 WITH SHIELD
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9896299
• MDR Text Key: 199070400
• Report Number: 2029214-2020-00305
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: PED2-425-16
• Device Catalogue Number: PED2-425-16
• Device Lot Number: A835008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63