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

Model Number PED2-250-12

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

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Medtronic received a report that pipeline moved during placement and was difficult to advance through the marksman catheter.The catheter was also difficult to navigate.The devices were replaced, and the same issues occurred with a second pipeline and marksman.A third device was successfully implanted, and the patient did not experience any injury or complications.No further medical/surgical interventions or hospitalization was needed.Angiographic results post procedure showed that the pipeline was implanted correctly, and the distal brain flow was preserved.The patient was undergoing treatment for a ruptured aneurysm located in the a2 segment of the right anterior cerebral artery.The max diameter was 3mm, and the neck diameter was 2mm.The access vessel was the right femoral artery.Ancillary devices include a catalyst guide catheter, traxcess guidewire, and guidewire hybrid.Technique: patient under general anesthesia, performed right femoral puncture, with the placement of a short bf introducer through which the neuromax 088 long sheath passed, aided by a 0.035x180cm hydrophilic guide for preliminary angiographic study.Sequentially, a long sheath is positioned in the petrous segment of the right internal carotid artery.Then, through a coaxial system formed by catalyst intermediate catheter, marksman microcatheter (3 units) on traxess 0.014 micro guide (2 units) and hybrid 0.008 microglia, microcatheterization of the distal segment of the right anterior cerebral artery was performed.An attempt was made to release the 2.5x10 pipeline stent (ref ped2-250-10; lot b127864) and 2.50x12 pipeline stent (ref ped2-250-10; lot b143786), without success due to failure in navigability within the microcatheter, making it impossible to the advancement of the stent to the arterial lumen.Sequentially, through a new set formed by a marksman 27 microcatheter and a 2.75 x 12 mm pipeline stent (lot b125279), the stent adjacent to the aneurysmal neck was released without complications.Control cerebral angiography was performed, which showed an adequately positioned stent and preserved distal arterial flow.Chemical angioplasty was performed with 10mg of milrinone.The sheath was removed in the room and an angioseal 6f arterial sealer was implanted in the right common femoral artery.Result: presence of an irregular saccular aneurysm in the pericallosal artery, a branch of the right anterior cerebral artery, measuring approximately 2x2mm.After the procedure, proper placement of the flow-diverting stent over the aneurysmal neck was observed, with preserved distal cerebral flow.Absence of cerebral vasospasm.Other intracranial arterial branches without abnormalities.Habitual superficial and deep venous return in left anterior and posterior circulation.Free carotid bulbs.Conclusion: endovascular treatment of aneurysm in the right pericallosal artery with the implantation of a flow-diverting stent.

Manufacturer Narrative

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 distal section of the catheter had resistance.There was no damage observed to the pipeline or catheter.

Manufacturer Narrative

H3.Product analysis: equipment used: video inspection system (m-78210), ruler (m-83361), pin gauge (m-84083 m-84081) camera (panasonic lumix dmc-zs5), 0.0260¿ mandrel as found condition: the pipeline flex w/ shield pusher and marksman micro catheter were returned for analysis within a shipping box and within an unsealed plastic pouch.Visual inspection/damage location details: no flash or voids molded were found within the marksman catheter hub.The pusher was found extending out the hub 23.6cm.No damages or anomalies were found with the catheter hub.The marksman catheter body was found accordioned between 27.5cm and 25.6cm from the distal end.No damages or irregularities were found with the marker band or catheter tip.The distal pipeline flex pusher was found already advanced out of the micro catheter.The pipeline flex w/ shield pusher was advanced out with no resistance encountered.The pipeline flex w/ shield proximal pusher was found kinked between 24.2cm and 35.8cm from the proximal end.The hypotube was found stretched with the ptfe shrink tubing undamaged.No damages or abnormalities were found with the proximal bumper, resheathing pad and pad restraints.The ptfe dps sleeves and dps restraints was found undamaged.The tip coil was found stretched.The pipeline flex w/ shield braid was not returned for analysis.Testing/analysis: the marksman micro catheter total length was measured to be 168.5cm and the usable length was measured to be 160.7cm, which is within specification (specification: total (ref) = 167cm ± 3cm, usable = 160cm ± 3cm).The inner diameter was measured to be 0.027¿ at the distal end and ~0.0275¿ at the proximal end, which is within specification (specification: 0.027¿ ± 0.001¿).An in-house mandrel was then inserted into the marksman catheter hub, through the catheter body and out the distal end with no resistance encountered.Conclusion: based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ and ¿catheter resistance¿ could not be confirmed through device analysis.However, resistance was likely to have occurred during the procedure due to the found damages.Possible causes of resistance are damaged catheter, damage to ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, user pulls back on/torques wire advancing ped in micro catheter.From the damages seen on the hypotube (stretch), tip coil (stretch), pusher (kinked) catheter (accordion); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex w/ shield through the marksman catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity, or lack of continuous flush.As the braid was not returned for analysis, any contribution of the braid towards the resistance could not be determined.There was no non-conformance to specifications identified that led to the reported issues.There was no non-conformance to specification that led to the detachment issues.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
• 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: 12449319
• MDR Text Key: 280692718
• Report Number: 2029214-2021-01145
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: PED2-250-12
• Device Catalogue Number: PED2-250-12
• Device Lot Number: B143786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Date Device Manufactured: 07/13/2020
• 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
• Patient Age: 57 YR
• Patient Sex: Female