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

Model Number PED2-325-20

Device Problems Positioning Failure (1158); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Medtronic received a report regarding a pipeline stuck in the catheter and phenom resistance.The patient was undergoing surgery for treatment of a spindle shaped, unruptured aneurysm in the right internal carotid artery with a max diameter of 8.6 mm and a 8.6 mm neck diameter.The landing zone was 3 mm distally and 2.8 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level is unknown.Postoperative findings related to blood flow imaging showed no change.It was reported that fd placement in rt.Ic.The sofia and phenom 27 were induced to m1.The product was delivered to phenom27.The sleeve removal was performed inside sofia.The tip was deployed again using a wire push.As the tip began to open inside sofia, it was aligned with the deployment start position (p-com proximal) and then deployed while pulling sofia as well.The deployment was inadequate, so both phenom27 and sofia were resheathed.When the same deployment was performed 2 to 3 times, the pipeline got stuck inside sofia, so the wire could not move.Sofia, phenom 27, and pipeline were all retrieved.The procedure was continued after switching to a different product and the procedure was completed successfully.It was reported there was catheter resistance in the distal end of the shaft.It was also reported the pipeline got stuck in the distal end of the shaft during deployment.The microcatheter was not retracted to eliminate slack in the microcatheter in order to eliminate the stuck.The catheter was flushed with heparin-added saline during the procedure.It is unknown if there was catheter damage observed.It is unknown if there was damage to the delivery pusher.The pipeline was not used for an indication that is off-label.The device was prepared as indicated in the package insert.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a sofia catheter.New information was received.Terumo is the manufacture of the sofia catheter and was used for distal access catheter.The location of the aneurysm in the right internal carotid artery was more specifically located in the ic-cs.

Manufacturer Narrative

Device evaluated by mfr: product analysis of ped2-325-20, lot# b350373 ¿ the pipeline flex pusher was found extending out from within the phenom 27 catheter hub for 35.3cm.The phenom 27 catheter body was found accordioned from 4.5cm to 2.5cm from the distal tip.The phenom 27 catheter distal tip was found in good condition.The pipeline flex pusher was found to have detached at the distal hypotube weld (solder joint).The pipeline flex pusher distal core wire, sleeves, and tip coil were found bent.The pipeline flex braid was found stuck within the sofia catheter distal tip.The pipeline flex braid proximal end was found damaged (frayed).The pipeline flex braid middle segment was found twisted.The pipeline flex braid distal end was found in good condition.Testing/analysis: the pipeline flex embolization device was pushed out from within the phenom 27 catheter.The sofia catheter was dissected (cut) to remove the pipeline flex braid.The detached pipeline flex pusher was sent out for sem / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed.Damage to the pipeline flex embolization device (braid fraying/twisting, pusher detachment) and phenom 27 catheter (accordioning) can occur if the device is advanced/retrieved against resistance.Possible causes of ¿resistance/stuck during delivery¿ include use of an incompatible catheter, catheter damage, patient vessel tortuosity, user does not maintain continuous flush, or users pulls back on/torques wire while advancing/retrieving the pipeline in the catheter.The phenom 27 catheter is compatible for use with the pipeline flex embolization device, ruling out ¿incompatible catheter¿ as a potential cause.The patient¿s vessel tortuosity was ¿moderate¿, ruling out ¿patient vessel tortuosity¿ as a potential cause.The phenom 27 catheter was continuously flushed, ruling out ¿user does not maintain continuous flush¿ as a potential cause.In this event, it is likely that the pipeline flex was pulled back/torqued during the resheathing of the device more than two (2) times.Regarding the pipeline flex pusher detachment, detachment can occur due to inadequate solder/tinning.The analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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 was received that the distal section of the pipeline did not open.The pipeline was placed in bend.There were no additional steps taken to try and open the pipeline.The pipeline was resheathed a few times.Approximately 1/4 of the device was deployed when it failed to open.

Manufacturer Narrative

H3: updated product analysis of (b)(4), lot#b350373 ¿ damage location details: the pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~35.3cm.The phenom 27 catheter body was found accordioned from ~4.5cm to ~2.5cm from the distal tip.The phenom 27 catheter distal tip was found in good condition.The pipeline flex pusher was found to have detached at the distal hypotube weld (solder joint).The pipeline flex pusher distal core wire, sleeves, and tip coil were found bent.The pipeline flex braid was found stuck within the sofia catheter distal tip.The pipeline flex braid proximal end was found damaged (frayed).The pipeline flex braid middle segment was found twisted.The pipeline flex braid distal end was found in good condition.¿ testing/analysis: the pipeline flex embolization device was pushed out from within the phenom 27 catheter.The sofia catheter was dissected (cut) to remove the pipeline flex braid.The detached pipeline flex pusher was sent out for sem / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).¿ conclusion: based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed.Damage to the pipeline flex embolization device (braid fraying/twisting, pusher detachment) and phenom 27 catheter (accordioning) can occur if the device is advanced/retrieved against resistance.Possible causes of ¿resistance/stuck during delivery¿ include use of an incompatible catheter, catheter damage, patient vessel tortuosity, user does not maintain continuous flush, or users pulls back on/torques wire while advancing/retrieving the pipeline in the catheter.The phenom 27 catheter is compatible for use with the pipeline flex embolization device, ruling out ¿incompatible catheter¿ as a potential cause.The patient¿s vessel tortuosity was ¿moderate¿, ruling out ¿patient vessel tortuosity¿ as a potential cause.The phenom 27 catheter was continuously flushed, ruling out ¿user does not maintain continuous flush¿ as a potential cause.In this event, it is likely that the pipeline flex was pulled back/torqued during the resheathing of the device more than two (2) times.Regarding the pipeline flex pusher detachment, detachment can occur due to inadequate solder/tinning.The analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Regarding the customer¿s ¿difficult placement/positioning¿ report the issue was confirmed.Possible causes of ¿difficult placement/positioning¿ include patient vessel tortuosity, braid incorrectly sized to vessel, resistance, braid damaged, or deployment techniques.The patient¿s vessel tortuosity was ¿moderate¿, ruling out ¿patient vessel tortuosity¿ as a potential cause.The pipeline flex embolization device appears to be correctly sized to the vessel, ruling out ¿braid incorrectly sized to vessel¿ as a potential cause.In this event, it is likely the reported resistance during delivery, damage to the pipeline flex braid, and the deployment technique (deployment within sofia/pushing out of catheter) contributed to the difficult placement 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.

Manufacturer Narrative

Additional fdd code added to h6.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 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: 16364771
• MDR Text Key: 309599905
• Report Number: 2029214-2023-00259
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-325-20
• Device Catalogue Number: PED2-325-20
• Device Lot Number: B350373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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: 72 YR
• Patient Sex: Female