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

Model Number PED-450-20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/20/2023

Event Type  malfunction  

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 Description

Medtronic received information that a ped pipeline could not be recovered.The device was delivered to the middle cerebral artery no rmally, the tip of the stent was deployed, and its opening was good.When pulling it backfor anchoring, the anchoring position of the stent was lower than the pre-determined position.Then the stent was planned to be recovered and deployed again, but the stent could not be recovered, and the stent was felt to be detached, and the push rod had been displaced, so the stent and the microcatheter were withdrawn from the body together.After replacing a stent, the operation was completed smoothly.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, saccualr aneurysm in the left ophthalmic artery.The max diameter was 6mm and the neck diameter was 4mm.The distal landing zone was 4.0mm and the proximal landing zone was 4.7mm.Vessel tortuosity was moderate.Dual antiplatelet treatment was administered.No patient injury or sympotoms were 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.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 received the cause of the pushrod detaching was not determined.Because the stent push rod and the stent, the microcatheter occurred a relative displacement, and the push rod was withdrawn, but the stent did not move.So it was judged as dislodgement.

Manufacturer Narrative

H3: product analysis #(b)(4):¿ equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5), in-house 0.026in mandrel ¿ drawing(s) referenced:fa-55xxx-xxxx rev.Q ¿ as found condition: the pipeline flex was returned stuck inside the marksman catheter; inside of a sealed bio-hazard bag and a shipping box.¿ damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the braid were found fully opened and frayed.Bends were found at 18.5cm to 23.7cm from the proximal end of the pushwire.The pushwire was found intact.No separation was found.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordioned at 4.0cm to 32.2cm from the distal tip.No other anomalies were observed.¿ testing/analysis: the pipeline flex was pushed out from the catheter lumen with difficulty.The catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.026¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.¿ conclusion: based on the returned devices, the customer complaint was not confirmed as the pushwire was found intact.No separation was observed on the pushwire.However, the returned pipeline flex and markman catheter were damaged.From the damages seen on the catheter (accordioning), braid (fraying), pushwire (bending), and hypotube (stretching); it appears there was high force used.It is possibly these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance.However, the cause of resistance could not be determined.Possible cause of resistance includes lack of continuous flush with heparinized saline during delivery.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.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: 17237771
• MDR Text Key: 318288315
• Report Number: 2029214-2023-00977
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: B464725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 68 KG