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

Model Number	PED-450-25
Medical Device Problem Codes	Retraction Problem (1536); Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline sleeves became stuck on the microcatheter during retrieval and scraped the pipeline into the aneurysm sac.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 11.3mm and a 6.7mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that the microcatheter was in place, the pipeline was deployed smoothly with no issues.After deployed, the distal segment of the pushwire could not be retrieved because the distal ptfe protective sheath was stuck with the tip of the microcatheter.Repeated attempts at retrieval failed, and the physician had to withdraw the system as a whole.When withdrawing, the protective sheath rubbed the tip of the pipeline which resulted in the pipeline scraped into the aneurysm sac.Another pipeline was selected and deployed and retrieved smoothly.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 angiographic results showed slow blood flow.
Event or Problem Description
Additional information received reported that the first pipeline that slipped into the aneurysm sack was not removed as it was completed deployed and could not be removed.Ancillary devices include a marksman microcatheter.
Additional 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.
Additional Manufacturer Narrative
H3: the pipeline flex pusher was returned.There was no pipeline flex braid or catheter returned with the pusher.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.No bend found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.Based on the returned pusher, the pipeline flex was not confirmed to have device migration.The root cause could not be determined as the pipeline flex braid was not returned.In addition, no images were provided for review.No damage was found with the pipeline flex pusher.Since the pipeline flex braid was not returned; any contribution of the braid to the issue could not be determined.There was no non-conformance to specifications identified that led to the reported issue.Per our instructions for use (ifu): ¿select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration.¿ the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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
• Common Device Name: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10407523
• Report Number: 2029214-2020-00797
• Device Sequence Number: 16805058
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: B002741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/09/2020; 01/24/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/23/2020; 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1