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

Model Number PED2-475-25

Device Problems Difficult or Delayed Activation (2577); Unintended Movement (3026); Activation Failure (3270)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Physician information was not reported due to region privacy laws.This original information in this report has been previously reported under regulatory report # 2029214-2021-00531 but later it was discovered the events were duplicated.All further information regarding this event will be reported under this regulatory report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that after failed deployment of one pipeline, the second pipeline also failed to open and there was diff iculty during deployment.The patient was undergoing treatment for a cavernous aneurysm with a maximum diameter of 13mm.The distal vessel diameter was 4.8mm, and the proximal vessel diameter was 4.9mm.It was reported that when the sleeve of pipeline was removed on the middle cerebral artery the deployment was poor.However, the mic rocatheter was dropped on the internal carotid artery without any actions, and the deployment was started. the distal end of the stent opened in the landing zone on the distal side, but the stent did not open at all beyond the tortuous part. after that, when wire pushing and resheathing were performed several times to open the stent, it was confirmed that the tip coil of pipeline did not move even when the wire was pushed and pulled, and the behavior seemed to deviate from the wire. before the tip coil distally migrated, slowly cover the tip coil with phenom 27, and removed the device together with the phenom27 without any actions.The phenom 27 and pipeline were replaced. the event was said to be not associated with a patient. the devices were prepared and hydrated according to the instructions for use (ifu).Additional information received regarding the second pipeline reported the pipeline was positioned in a vessel bend.This pipeline was also resheathed at least 15 times.There was no friction felt at the time of the delivery.At the time of positioning, the tip was unfolded, an anchor was applied, and the stent was not opened in the middle at the point where it exceeded the flexion.During deployment, the tip of the catheter was controlled to be in the center of the blood vessel.

Manufacturer Narrative

Pma/510(k) corrected.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

H3: no damages or irregularities were found with the phenom-27 catheter hub.Dried blood was found within the hub.The distal ~15cm of the phenom-27 micro catheter was found wavy (bent).No damages or irregularities were found with the distal tip and marker band.The pipeline flex w/ shield pusher was found stuck within the micro catheter.The braid was already deployed.Both ends were found fully opened, damaged and frayed.The pusher was retracted out against resistance.Dried blood was found within the phenom-27 micro catheter and on the pipeline flex w/ shield pusher.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.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.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed.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.Customer reported device was not placed in a bend, less than 5% was deployed, pipeline was resheathed 3 or more times and patient vessel tortuosity as severe.It is possible the coagulated blood contributed towards the failure to open.The phenom-27 was found bent.Possible causes are patient vessel tortuosity, possible oversized od, guidewire or delivery system removed aggressively, catheter entrapment or user advances/retrieves device against resistance.There is no indication that the event is related to a potential manufacturing issue.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

H3: no damages or irregularities were found with the phenom-27 catheter hub.Dried blood was found within the hub.The distal ~15cm of the phenom-27 micro catheter was found wavy (bent).No damages or irregularities were found with the distal tip and marker band.The pipeline flex w/ shield pusher was found stuck within the micro catheter.The braid was already deployed.Both ends were found fully opened, damaged and frayed.The pusher was retracted out against resistance.Dried blood was found within the phenom-27 micro catheter and on the pipeline flex w/ shield pusher.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.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.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed.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.Customer reported device was not placed in a bend, less than 5% was deployed, pipeline was resheathed 3 or more times and patient vessel tortuosity as severe.It is possible the coagulated blood contributed towards the failure to open.The phenom-27 was found bent.Possible causes are patient vessel tortuosity, guidewire or delivery system removed aggressively, catheter entrapment or user advances/retrieves device against resistance.There is no indication that the event is related to a potential manufacturing issue.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11924731
• MDR Text Key: 254026780
• Report Number: 2029214-2021-00651
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: B049757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 07/09/2021; 07/30/2021
• Supplement Dates FDA Received: 06/22/2021; 07/27/2021; 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1