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

Model Number PED2-500-18

Device Problem Activation Failure (3270)

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

Event Date 07/15/2020

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 device failed to deploy at the distal segment of the pipeline.It was reported that unsheathing was performed inside the vessel in order to deploy the pipeline, but the deployment failed at the distal segment.Insertion and removal were performed many times, but the physician decided to retrieve the device.It was noted the pipeline was not in a bend, more than 50% of was deployed, and re-sheathing was done three or more times.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.Ancillary devices include a 6fr fubuki guiding sheath, phenom 27 microcatheter.

Event Description

Additional information received reported the patient's vessel tortuosity was severe.

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.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

H3: the pipeline flex with shield embolization device (model: ped2-500-18 lot: a826933) and phenom 27 catheter (model: fg15150-0615-1s, lot: jl19-042) were returned for analysis.The pushwire was found to be separated/broken proximal to the dps sleeves.For further examination, the tip coil, dps sleeves and braid were removed from the catheter lumen.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 to be stretched.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No bend or kink were observed on the pushwire.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip without any issues.The distal and proximal ends of the pipeline flex braid were found opened and moderately frayed.The total and usable lengths of the catheter were measured to be within specifications.No damages were found with the phenom-27 hub.No flash o r voids molded were observed in the hub.The phenom-27 catheter body was found flattened at ~0.5cm from distal tip.No damages were found with distal tip and marker band.No other anomalies were observed.Based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at distal.The pipeline flex shield braid were found fully opened and moderately frayed.The damage to the pipeline flex braid ends and the stretched distal hypotube are likely the result of the physician re-sheathing the device more than recommended two times.Additionally, the pushwire was found to be separated proximal to the dps sleeves.Per the sem result features observed indicate the wire failed via torsional overload failure mechanism.It is likely that the patient tortuous anatomy may have contributed to this event.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 W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10287280
• MDR Text Key: 201726497
• Report Number: 2029214-2020-00698
• 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
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: A826933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 09/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1