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

Model Number PED2-425-14

Device Problems Positioning Failure (1158); Unintended Movement (3026)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Medtronic received information that one ped2 pipeline failed to open and two pipelines had movement during deployment and had difficult placement and positioning.The patient was being treated for an unruptured carotid siphon aneurysm.Vessel tortuosity was severe.The devices were prepared according to the instructions for use (ifu).  pipeline 4.25x14 and 4.5x14 were not deployed because the system kept falling down after the initial deployment.Multiple pipelines were not being used when the movement occurred.There was no friction or difficulty during delivery or positioning.The pipeline was not implanted at the intended location.No additional steps were taken.The pipelines missed the landing zone.The device did not jump during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side.The tip of the catheter moved during the deployment.The procedure was successful and stent was deployed, stagnation was observed during the angiogram (post procedure).No symptoms were reported.  ancillary devices: navien guide catheter, phenom27 lot ap21-053 microcatheter, phenom 27 lot ju21-035 microcatheter, sheath.

Manufacturer Narrative

Event related to report 2029214-2022-00426.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported dual antiplatelet therapy was administered.For the first pipeline, close to 75% had been deployed when it failed to open.Just proximal to the point of no resheathing.The device was resheathed into the microcatheter.However, the microcatheter had fallen back and needed to be navigated distally which was not possible by itself with the ped within it.This would require a microcatheter and microwire.Therefore, attempted to remove the ped out of the microcatheter and of the body.However, it could not be captured into the introducer sheath.The ophthalmic side branch was covered.Not from movement of the device.

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.

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.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex embolization device was returned for analysis within a shipping box, within an opened pipeline flex outer carton (b087392), and within a dispenser coil.Visual inspection/damage location details: the pipeline flex pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The pusher was found detached at the distal hypotube weld (solder joint).The pusher distal segment (resheathing pad, sleeves, tip coil) and braid were not returned.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿difficult placement/positioning¿ and ¿movement during deployment¿ reports could not be confirmed.Difficult placement/positioning and movement during deployment can be caused by vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, microcatheter tip not correctly placed, insufficient distal anchoring of braid, braid deployed in vessel bend, or incorrect braid sizing.In this event, it is likely the catheter kickback and the patient¿s ¿severe¿ vessel tortuosity contributed to the events.Regarding the damages found with the pipeline flex pusher (stretching/separation) it appears force was used.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 issue.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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
• 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: 13796390
• MDR Text Key: 287350861
• Report Number: 2029214-2022-00427
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Model Number: PED2-425-14
• Device Catalogue Number: PED2-425-14
• Device Lot Number: B087392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2020
• 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