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

Model Number PED2-275-14

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline pushwire broke after experiencing resistance in the marksman microcatheter, which also had resistance in the navien guide catheter.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right middle cerebral artery.The patient's vessel tortuosity was moderate. dual antiplatelet treatment was administered.It was reported that the pipeline device was successfully released and implanted, but during the removal of the delivery wire from the system, the doctor observed resistance of the delivery wire in relation to the marksman microcatheter and also of the microcatheter in relation to the navien intracranial access catheter.After that, the doctor opted for the removal of the two systems.At this time it was observed that the distal portion of the delivery wire had fractured and completely detached from the system.The microcatheter and intracranial catheter were irrigated looking for this distal part.This was successful, and after the doctor made sure that they were not found in the operative field, they identified the part mentioned on the floor of the room. it was noted that when removing the delivery wire, the doctor did not raise the marksman microcatheter inside the stent to cover the delivery wire (tip coil), not following the recommendations. no extended hospitalization or additional medical/surgical interventions were needed.Angiographic results post procedure showed no problems, and the results were as expected. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a navien 6f guide catheter, marksman microcatheter, and avigo guidewire.

Manufacturer Narrative

G3: 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

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 reported the instructions for use were not followed.The physician was going down with the tip coil inside the stent, but should have gone up with the marksman inside the stent and put the tip coil inside the marksman, which did not happen.The physician pulled the delivery wire without the sleeves being inside the microcatheter and at the time of removal there was a resistance close to acm when first starting to remove, the tip coil was not seen, but was observed once outside the patient's body.It was noted that the resistance occurred at the distal end of both the navien catheter and the marksman microcatheter.

• 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: 11838577
• MDR Text Key: 251191859
• Report Number: 2029214-2021-00588
• 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
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: PED2-275-14
• Device Catalogue Number: PED2-275-14
• Device Lot Number: A834391
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR