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

Model Number	PED-500-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
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 information regarding a pipeline flex that failed to open at the distal end.The patient was being treated for an unruptured saccular aneurysm of the left internal carotid artery (ica).The aneurysm max diameter was 11mm and the neck diameter was 6mm.Vessel tortuosity was severe.It was reported that the pipeline was positioned in the m1-m2 segment and more than half the device was unsheathed, exposing the entire distal segment.However, when unsheathed, the distal segment of the device was not opening.The pipeline was resheathed three times but opening continued to fail.The pipeline was then removed along with the microcatheter.Both the pipeline and the catheter were replaced with devices of the same models.The procedure was then completed successfully.There was no harm or injury to the patient.
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.
Event or Problem Description
Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated there was no visible damage to the devices observed.
Additional Manufacturer Narrative
H3: the pipeline flex embolization device (model: ped-500-20 lot: a843372) and a phenom 27 catheter (model: fg15160-0615-1s lot: ju19-019) were returned for analysis.The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found protruding from within the phenom 27 catheter hub for ~36.0cm.No damage was found with the phenom 27 catheter hub.No bends or kinks were found with the phenom 27 catheter body.No damage was found with the phenom 27 distal marker/tip.The pipeline flex tip coil was found protruding from within the phenom 27 distal tip.The phenom 27 catheter total length was measured to be ~169.0cm and the useable length was measured to be ~162.5cm which is within specification.The pipeline flex pusher was removed from within the phenom 27 catheter without issue.However, the tip coil remained within the phenom 27 catheter tip.No bends or kinks were found with the pipeline flex pusher.The distal hypotube with the ptfe shrink tubing was found intact.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The distal segment of the pipeline flex pusher (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip coil) was found detached.The pipeline flex pusher distal segment was removed from within the phenom 27 catheter tip.The proximal bumper, re-sheathing pad, and re-sheathing marker were found to be intact.The pipeline flex braid was found deployed on the distal pushwire.Dried blood was present on the pipeline flex braid.The pipeline flex braid proximal end was found fully open and in good condition.The pipeline flex braid distal end was not fully open and appears to be damaged.The distal and proximal dps restraints were found to be intact.The ptfe sleeves were found intact.The tip coil was found bent.Dried blood was present on the ptfe sleeves and tip coil.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows elevated iron (fe), tin (sn) and chromium (cr) peaks were detected on the wire surface.No other anomalies were observed.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review will be performed.Based on the device analysis and reported information, the customer¿ s report of ¿failure/incomplete open distal¿ could not be confirmed based on device evaluation, as the device has been fully deployed and re-sheathed.In addition, no images were provided for review.Failure to open can be caused by patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.It is possible the patient¿s ¿severe¿ vessel tortuosity contributed to the event.However, the cause could not be determined.Regarding the damages found with the returned pipeline flex embolization device (pusher detached, tip coil damage) it appears there was excessive force use.Damage is likely to occur if the device is advanced/retrieved against resistance.In addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the resistance and detachment issues.Furt hermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.The investigation determined that these events were similar to events that had already been investigated, and another investigation is not necessary.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: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10101402
• Report Number: 2029214-2020-00505
• Device Sequence Number: 14053515
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2020

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: 06/05/2022
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A843372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 08/09/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/08/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR