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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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 after the pipeline was delivered, the distal segment of the stent could not be opened.The operating instructions were followed to deploy, and it was withdrawn after waiting more than 10 minutes.Another attempt to deploy was made, but the stent still could not be opened.It was noted the pipeline was not positioned in a bend, more than 50% of the stent had been deployed, resheathing was performed more than twice, and no additional steps or other devices were used to open the pipeline.The pipeline and catheter were withdrawn together, and replacement devices were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu),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 the effect of the blood flow guidance was satisfactory.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the end of the inner left neck with a max dia meter of 7.39 mm and a 4.5 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was unknown if dual antiplatelet therapy (dapt) was administered.Ancillary devices include a phenom27 fg15150-0630-1s; lot:ma20-009.
Additional Manufacturer Narrative
H3: the pipeline flex device was returned for analysis.The pipeline flex braid was already detached.The phenom-27 micro catheter used during the event was not returned for analysis.No damages or irregularities were found with the introducer sheath.The pipeline flex hypotube was found stretched with the ptfe shrink tubing still intact.The distal delivery wire was found separated from the hypotube proximal to the wire weld.The distal wire was not returned for analysis.No damages were found with the bumper hole.Evidence of tinning was seen at the hole opening.As the distal wire was not returned, the wire could not be sent out for eds analysis.One end of the braid was found fully opened, severely damaged, frayed and flattened.The middle braid was found damaged.The other braid end was not fully opened, severely damaged and frayed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed, however, the cause could not be determined.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braids were returned already deployed and out of its protective introducer sheath and dispenser coil.Customer reported all devices were prepared per ifu, pipeline not positioned in a bend, more than 50% of stent was deployed, resheathing was performed more than twice and patient vessel tortuosity as moderate.The hypotube was found stretched, indicative of retraction against resistance.As the phenom-27 micro catheter used in the event was not returned for analysis, any contribution of the phenom-27 micro catheter to the failure could not be determined.The phenom-27 micro catheter is compatible for use with the pipeline flex.The distal wire of the pipeline flex 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.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).As the distal wire was not returned for analysis, the wire end could not be sent out for energy dispersive spectroscopy (eds) testing for presence of tin, however solder tin was found around the opening of the proximal bumper.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: 11938157
• Report Number: 2029214-2021-00662
• Device Sequence Number: 11818850
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 12/17/2023
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: B135050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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