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

Model Number PED3-027-500-16

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

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Medtronic received a report that three pipelines were unable to be resheathed, two had movement during deployment, and one was damaged.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the posterior communicating artery.The max diameter was 5mm, and the neck diameter was 6mm.The patient's vessel tortuosity was moderate.The landing zone was 3.4mm distal and 4.7mm proximal. dual antiplatelet treatment was administered.The access vessel was the ica, which was 3.4mm in diameter.It was reported that the patient had difficult proximal anatomy and tortuous distal anatomy.A sophia 5f catheter and phenom 27 micr ocatheter were navigated into the m1, and the first pipeline vantage was attempted to be deployed.The aim was to land the distal end of the stent just below the terminus which gave 6mm of distal landing zone before the neck of the aneurysm.The stent deployed well until the neck of the aneurysm where the physician attempted to load the device.The device would not respond to load (not enough support in the system combined with tortuosity).During the loading the distal end of the stent slipped back and needed to be re-sheathed.The physician attempted to re-sheath with forward tension on the microcatheter and pulling on the pusher wire but there was no translation of these forces on the screen and the device could not be re-sheathed.Load was taken out of the whole system and re-sheathing was attempted again but this did not help.Eventually the whole device dropped back into the aneurysm and the sophia was used to re-sheath the device and it and the phenom 27 were removed.A visible kink was noted on the distal part of the phenom 27.A second phenom 27 was navigated to the m1 and a second vantage was deployed.The device deployed well but the physician did not load through the aneurysm.The device was slightly too long because length was not lost in the actual aneurysm as expected and ended in a curve causing the device to ribbon.While attempting to remove the ribbon the distal end of the stent slipped back again and the device was recaptured with the sophia.In the sophia the device was fully recaptured.The physician decided to use a shorter third vantage.A third phenom 27 was navigated distal to the aneurysm into the m1 and a 5x14 was deployed in the same manner.The initial deployment was too proximal to the terminus and the physician attempted to re-sheath and again the device locked up and could not be re-sheathed.After unloading, deploying more stent and re-capturing with the sophia, none of which allowed the device to be re-sheathed at all, the third vantage was removed.A 5x21 fred and headway 27 were used.The initial fred deployment resulted in the same situation as the vantage.It was kept and deployed again through a second headway duo.It was able to be deployed with he stent segment covering the a1.The proximal end landed long and ribboned but was opened with the pusher wire.The end result was good and the patient woke up from the procedure and recovered from the procedure well.There had been no damage to the pipeline pushwires or the second or third phenoms.A continuous flush had been administered.Angiographic results post procedure showed the replacement device was implanted successfully with good angiographic results.The patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).

Manufacturer Narrative

See manufacturer report # 2029214-2023-00026 for the other pipeline involved in this event.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 that the cause o the event was due to the catheter was kinking.The device jumped during deployment.The tip of the microcatheter came back as the device was deployed.There was not a stable platform so it did come back quickly during initial 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-78210), 203cm ruler (m-83361) ¿ drawing(s) referenced: m993573adoc1 rev.B ¿ as found condition: the pipeline vantage embolization device and phenom 27 catheter were returned for analysis within a shipping box, within a primary plastic bio-pouch, and within a secondary plastic pouch.The pipeline vantage embolization device was returned within the phenom 27 catheter.¿ damage location details: the phenom 27 catheter was returned with an rhv device still attached to the catheter hub.The pipeline vantage pusher was found bent at the rhv hub ~32.5cm from the pusher proximal end.The rhv device was removed from the phenom 27 catheter hub.The pipeline vantage pusher was found extending out from within the phenom 27 catheter hub for ~39.5cm.No damages were found with the phenom 27 catheter hub.The phenom 27 catheter body was found damaged (accordioned) at ~2.7cm from the catheter distal tip.The pipeline vantage braid was found partially deployed out from within the phenom 27 catheter distal tip.The pipeline vantage pusher was found bent at ~44.0cm, ~65.0cm, and ~86.5cm from the pusher proximal end.The pipeline vantage pusher distal hypotube was found stretched.The pipeline vantage braid proximal and distal ends were found open, but damaged (frayed).The pipeline vantage pusher sleeves were found in good condition.The pipeline vantage pusher tip coil was found bent.¿ testing/analysis: the pipeline vantage embolization device was pushed out from within the phenom 27 catheter.The length from the dps restraint to the bumper face was measured to be ~38.4mm (specification (m993573a034): 38.3mm +0.00 -0.6) ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿movement during deployment¿ report could not be confirmed.Possible causes of ¿movement during deployment¿ include vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, insufficient distal anchoring of braid, or incorrect braid sizing.However, the cause could not be determined.Regarding the customer¿s ¿resistance during re-sheathing/failure to resheath¿ report, the issue was confirmed.Possible causes of ¿resistance during re-sheathing/failure to resheath¿ include patient vessel tortuosity, ped/delivery system damage, catheter damage, user does not maintain continuous flush, or user resheaths more than 2 times.In this event, it is likely the damage found with the phenom 27 catheter contributed to the event.(rosaj10 2023-02-10) 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 VANTAGE WITH 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: 16102224
• MDR Text Key: 308633927
• Report Number: 2029214-2023-00029
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-500-16
• Device Catalogue Number: PED3-027-500-16
• Device Lot Number: B375682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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