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

Model Number PED-375-30

Device Problems Positioning Failure (1158); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Medtronic received information that a ped pipeline had movement during deployment and had resistance resheathing in marksman.Ped landed in middle of right m1 location, then continued pushing.Suddenly, ped jumped into aneurysm (missed landing zone).Doctor re-sheathed ped try to reposition.It was hard to resheath (felt huge resistance).Marksman can't advance, then doctor pulled back whole system out of body (marksman and ped).Found accordion in middle of marksman.The catheter was flushed continuously with heparanized saline.The pipeline was stuck in the middle of the catheter during resheathing.The physician released the load in the system in an attempt to resolve the issue.The issue did not resolve.The middle of the catheter had accordion damage.The pushwire was not damaged.The patient was being treated for an unruptured, fusiform aneurysm in the m1-c6 location.The max diameter was 16 x 8.3mm.The neck diameter was 14mm.The distal landing zone was 2.74mm and the proximal landing zone was 3.67mm.Vessel tortuosity was minimal.Dual antiplatelet treatment was administered.Angiographic result post procedure was normal.No patient symptoms or complications w ere reported.

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.

Event Description

Additional information received reported that the device was prepared as indicated in the ifu.Hydration was completed like in-service protocol.Multiple pipeline devices were not being used when movement occurred.There was no friction or difficulty during delivery or positioning.The device did not jump during deployment.The tip of the catheter did not moved during deployment.

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

H3: product analysis #(b)(4):¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ drawing(s) referenced: none ¿ as found condition: the pipeline flex embolization device and marksman catheter were returned for analysis within a shipping box and within a plastic pouch.The pipeline flex embolization device was returned within the marksman catheter.¿ damage location details: the pipeline flex pusher was found extending out from within the marksman catheter hub for ~48.7cm.No damages were found with the marksman catheter hub.The marksman catheter body was found accordioned at ~26.2cm and ~24.6cm from the catheter distal tip.The pipeline flex tip coil was found extending out from within the marksman catheter distal tip.No damages were found with the marksman catheter distal tip.No bends or kinks were found with the pipeline flex pusher.The pusher resheathing pad and sleeves were found in good condition.The pusher tip coil was found stretched.The pipeline flex braid was not returned with the pusher.¿ testing/analysis: the pipeline flex pusher was pushed out from within the marksman catheter without issue.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿difficult placement/positioning¿ and ¿movement during deployment¿ reports could not be confirmed.However, the customer¿s ¿resistance during re-sheathing¿ and ¿resistance during retrieval¿ reports were confirmed.Damage to the marksman catheter (accordioning) can occur if the device is advanced/retrieved against resistance.Possible cause include patient vessel tortuosity, braid incorrectly sized to vessel, vasospasm, braid damaged, user does not maintain continuous flush, catheter damage, incompatible catheter, catheter kickback, braid deployed in vessel bend, or braid not anchored correctly.Information regarding if there was any vasospasm or if the braid was deployed in a vessel bend was not reported; therefore, vasospasm and braid deployed in vessel bend could not be ruled out as potential causes.The pipeline flex braid was not returned; therefore, braid damage could not be ruled out as a potential cause.Vessel tortuosity was minimal, the braid appears to be correctly sized to the vessel, the marksman catheter was flushed continuously with heparinized saline, the marksman catheter is compatible with the pipeline flex embolization device, and the tip of the catheter did not move during deployment.Therefore, patient vessel tortuosity, braid incorrectly sized to vessel, user does not maintain continuous flush, incompatible catheter, and catheter kickback were ruled out as potential causes.It is possible the damage to the marksman catheter (accordioning) contributed to the events.(rosaj10 2023-03-22) 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
• 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: 16132999
• MDR Text Key: 308748391
• Report Number: 2029214-2023-00047
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-375-30
• Device Catalogue Number: PED-375-30
• Device Lot Number: B328799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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: 67 YR
• Patient Sex: Male