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

Model Number	PED2-350-12
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a case in which a pipeline flex with shield was used.No other information was provided and thus no complaint was noted.Additional information received reported the pipeline shield was being deployed tortuous anatomy.The device was deployed a bit too proximal from desire location so the physician decided to resheath and reposition.During the re-sheathing process, the device became stuck in the micro-catheter and would not re-sheath.The microcatheter and flow-diverter were removed together.Both devices were replaced and a new flow diverter was successfully deployed with a new microcatheter.Additional information received reported that the device prepared as indicated in the ifu (inspection, hydration, etc.).It was noted that a phenom 27 catheter was used.No damage to the pipeline pushwire or catheter observed.Lesion characteristics (location, size, type, side, dimension,etc.): right pcom aneurysm, 3.5x3mm.The patient's vessel tortuosity was moderate.
Additional Manufacturer Narrative
The pipeline flex w/ shield device and phenom-27 micro catheter were returned for analysis.An rhv was found attached to the phenom-27 micro catheter hub.The pipeline flex w/ shield pusher was found extending out of the rhv ~46.0cm.No flash or voids molded were found within the phenom-27 catheter hub.No damages or irregularities were found with the hub.The phenom-27 micro catheter was found accordioned at ~6.4cm from the distal end.No damages or irregularities were found with the distal tip and marker band.The pusher was removed from the catheter with no resistance encountered.However, the distal delivery wire and braid were found separated from the hypotube proximal to the wire weld and remained stuck within the catheter.No damages were found with the pipeline flex w/ shield proximal pusher.The hypotube was found intact and unstretched with the ptfe shrink tubing intact.Evidence of solder was found around the hypotube hole.The phenom-27 micro catheter was cut to remove the distal delivery wire and braid.The resheathing pad, proximal bumper and resheathing marker were separated from the distal wire.The ptfe dps sleeves was found undamaged.The tip coil was found damaged.The proximal braid end was found tapered, frayed and damaged.The distal braid end was found fully opened, frayed and damaged.The phenom-27 total length was measured to be ~159.6cm and the usable length was measured to be ~152.5cm.As the model and lot numbers were not reported, conformation to specification could not be assessed.The separated distal wire was sent out for eds analysis.Based on the analysis findings, the customer report of ¿resistance during re-sheathing/failure to resheath¿ and ¿catheter resistance¿ were confirmed as the damages found are consistent with resistance.Possible causes are patient vessel tortuosity, resistance during delivery/retrieval, ped/delivery system damage, catheter damage, user does not maintain continuous flush or user resheaths more than 2 times.From the damages seen on catheter (accordion) the braid (damaged); distal wire (separation), resheathing pad/marker/proximal bumper (separation), and tip coil (damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex w/ shield through the phenom-27 catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity, or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.The distal wire of the pipeline flex w/ shield delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex w/ shield against resistance.A review of the manufacturing process did not uncover any deficiencies with regards to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.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 led to the detachment issues.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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14880773
• Report Number: 2029214-2022-01091
• Device Sequence Number: 17712818
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: 06/30/2023
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B048180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown