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

Model Number	PED2-475-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
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
Medtronic received a report that the physician advanced a pipeline into the distal ica and began to deploy the device with the distal end positioned in the paraophtalmic region.The device began to open but then showed a narrowing/trumpeting in the distal end.The device began to open proximal to that distal narrowing but the physician would not finish the deployment due to the distal end not being opened.The device was removed and another pipeline was advanced through the catheter all the way to the m1 region of the patient.The m1 region was much straighter and the physician began deploying the device.This time the distal end opened without narrowing/trumpeting.The physician let out about 8mm (1/2) of the device and then resheathed the device completely.She then pulled the system proximal into the same segment where she tried to deploy the first device (paraopthalmic).She began to deploy the device again and the same phenomenon happened with the distal narrowing/trumpeting.The physician removed the device and ended the case.The first pipeline was not positioned in a bend.The second pipeline proximal section was positioned in a bend.More than 50% of the both pipelines had been deployed when they failed to open.Both pipelines were resheathed more than 2 times.There were no additional st eps or other devices required to open the pipelines.The pipelines were resheathed and removed from the patient with the microcatheter. both pipelines were used for an indication that is approved (on-label).The pipelines and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The angiographic result post procedure was successful.The patient was undergoing surgery for treatment of a saccular, unruptured paraopthalmic, cavernous aneurysm with a max diameter of 7 mm and a 3 mm neck diameter.The landing zone was 3.9 mm in the distal end and 4.2 mm at the proximal end.It was noted the patient's vessel tortuosity was severe.Ancillary devices include a neuron max 088 90cm sheath, phenom 27 150cm microcatheter,  and a synchro2 200cm guidewire.
Additional Manufacturer Narrative
H3: product analysis #705259600:equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgsfg15xxx-yyyy-zz rev f as found condition: one pipeline flex w/ shield braid, one pipeline flex w/ shield device and one phenom-27 micro catheter were returned for analysis within shipping box; within a sealed tyvek biohazard pouch and within a resealable plastic pouch.Visual inspection/damage location details: (first pipeline flex w/ shield (braid only)) one braid end was found slightly tapered, damaged, and frayed.The other braid end was found fully opened, damaged, and frayed.(second pipeline flex w/ shield and phenom-27) no damages or irregularities were found with the phenom-27 catheter hub, catheter bod y, distal tip and marker band.The pipeline flex w/ shield pusher was found extending out the hub ~49.0cm.The micro catheter was flushed, and water did not exit the distal end.Blood was found to backflow back out the hub.The pipeline flex w/ shield device was a dvanced out of the phenom-27 against severe resistance.Dried blood was found throughout the micro catheter and on the pipeline flex w/ shield pusher and braid.The dried blood was dissolved.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.The proximal bumper, resheathing pad and pad restraint were found loose on the distal delivery wire.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact.Once the blood was dissolved, both braid ends were found fully opened, damaged, and frayed.Testing/analysis: (first pipeline flex w/ shield (braid only)) n/a (second pipeline flex w/ shield and phenom-27) the phenom-27 micro catheter total length was measured to be ~155.4 and the usable length was measured to be ~148.9cm.As the model and lot numbers were not reported, conformation to specification could not be determined.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed for the first braid but could not be confirmed for the second braid.Once the blood was dissolved on the second braid, both ends fully opened.Possible causes of failure to open 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 braids were 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 first braid was returned already deployed and out of its protective introducer sheath and dispenser coil.Customer reported second device was placed in a vessel bend, both devices were resheathed more than 2 times, patient vessel tortuosity as severe, and devices were prepared and flushed per ifu.It is possible the severe patient tortuosity contributed towards the failure to open, and the multiple resheathing contributed towards the braid damage.There was no damages or irregularities found with the phenom-27 that would contribute towards the incomplete open.The loose resheathing pad, proximal bumper and pad restraints is likely caused by the found resistance.Ngod10 2022-11-20 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
• 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: 15681567
• Report Number: 2029214-2022-01818
• Device Sequence Number: 6421820
• Product Code: OUT
• UDI-Device Identifier: 00763000284619
• UDI-Public: 00763000284619
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 06/27/2025
• Device Model Number: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: B407661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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: Female