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

Model Number PED2-450-16

Device Problems Positioning Failure (1158); Unintended Ejection (1234); Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Medtronic received a report regarding a pipeline failure to open distally, prematurely opened during resheathing, resistance, difficult placement, and movement during delivery.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery (ophthalmic) with a max diameter of 10 mm and a 4 mm neck diameter.The landing zone was 4 mm distally and 4.4 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dualantiplatelet treatment was administered.The pru level was 104.The angiographic result post procedure showed the aneurysm was coiled and atlas stent placed to protect patent carotid artery.It was reported that the patient was prepped for the procedure.Access was attained in the right femoral artery and a tracstar guide catheter was advanced into the left internal carotid artery.Phenom 027 was advanced into the left mca artery.Pipeline was prepped per instructions for use (ifu) and advanced into the phenom 027 catheter.During attempted deployment by the doctor, the pipeline distal end would not open.The doctor attempted several times to wag and push the device so that it would open and deploy.These attempts were unsuccessful.The doctor then attempted to re-sheath the device.During his attempt to re-sheath the device the device separated from the delivery system.Under fluoroscopy the device was no longer bound by the resheathing pad.The doctor was able to remove the device as it was still constrained by the phenom 027 enough to remove from the patient.The doctor changed his plan and coiled the aneurysm and placed an atlas stent in the carotid artery.The pipeline was not positioned in a bend.The pipeline had been deployed more than 50% when it failed to open.The pipeline was resheathed less than or equal to two times.There were no additional s teps or other devices required to open the pipeline.The pipeline was removed from the patient.The pipeline was resheathed and removed with the microcatheter.It was also reported there was movement during placement (difficult placement/positioning) that occurred.Multiple pipeline devices were not being used when the movement occurred.There was moderate friction and difficulty during delive ry/positioning.The pipeline was not implanted at the intended location.There were no additional steps required to remove or secure the pipeline.The pipeline missed the landing zone.The device did jump during deployment.The pipeline was placed at least 3 mm past the aneurysm neck on each side.There were no side branch(es) covered by the pipeline.The tip of the catheter was not moved during deployment.The patient did not suffer any injury during this procedure.Post angiographic result was satisfactory.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices include a tracstar sheath, phenom 27 guide catheter, aristotle 18 guide wire.

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.

Manufacturer Narrative

H3: the proximal end of the pipeline flex shield braid was found fully opened and moderately frayed.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.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 Description

Additional information was received that resistance occurred as the doctor was attempting to recapture the pipeline device, it did not occur as he was initially attempting to deploy the device.The distal end of the pipeline stent appeared to be frayed and not opening appropriately.Neither the pushwire or catheter appeared to be kinked or stretched.The pushwire was not rotated at any point during the deployment or recapture attempt.The pushwire was pulled back during the attempt to resheath the device.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: 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: 15895899
• MDR Text Key: 307838278
• Report Number: 2029214-2022-02030
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284527
• UDI-Public: 00763000284527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-16
• Device Catalogue Number: PED2-450-16
• Device Lot Number: B382445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG