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

Model Number PED-475-20

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 06/26/2022

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 a report that the distal part of the pipeline pushwire broke after the device had experienced resistance in the distal part of the phenom 27 microcatheter.A continuous flush had been administered.The devices were replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, amorphous aneurysm located on the patient's left side.The max diameter was 5mm, and the neck diameter was 6.The patient's vessel tortuosity was moderate.The landing zone was 3.3mm distal and 4.6mm proximal.The access vessel was 6mm in diameter. dual antiplatelet treatment was administered, and the pru level was 5.Ancillary devices include a cook sheath, navien guide catheter, sy14 guidewire, and qc coils.

Manufacturer Narrative

H3: the pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~45.5cm.The phenom 27 catheter hub was found in good condition.No bends or kinks were found with the catheter body.The catheter distal tip was found in good condition.The pipeline flex braid was found partially deployed out from the within phenom 27 catheter distal tip.The pipeline flex embolization device was removed from within the phenom 27 catheter.The pipeline flex pusher distal hypotube was found stretched with the shrink tubing pulled back from proximal bumper.The pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex braid proximal and distal ends were found open but damaged (frayed).The pipeline flex pusher distal core wire was found broken proximal to sleeves.The pusher sleeves and tip coil were not returned.The detached pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental and failure analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).The broken d istal core wire failed via overload.Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ and ¿pushwire break/separation¿ reports were confirmed.The pipeline flex pusher (stretching) and braid (fraying) can become damaged if advanced/retrieved against resistance, patient anatomy, resheathing more than 2 times, or over-manipulation.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 pipeline in microcatheter.Possible causes of pushwire break/separation and pushwire detach at hypotube proximal to the wire weld include patient vessel tortuosity, resistance/high force delivery, pushwire damage, hypotube stretch, catheter damage, over-manipulation, or user resheaths more than 2 times.In addition, separation can occur due to inadequate solder/tinning.The phenom 27 catheter is compatible for use with the pipeline flex embolization device, no defect was found with the returned phenom 27 catheter that would have contributed to the event, and a continuous flush had been administered.Information regarding how many times the pipeline flex was resheathed was not reported.It is possible the patient's moderate vessel tortuosity contributed to the resistance and device separation.As the broken distal core wire failed via overload it is likely the pipeline flex embolization device was torqued within the phenom 27 catheter.In addition, as the pusher was found stretched it is likely excessive force was used.The analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that led to the detachment issue.Furthermore, 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

No damage to the catheter was observed.

• 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: 14842477
• MDR Text Key: 301656335
• Report Number: 2029214-2022-01070
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-20
• Device Catalogue Number: PED-475-20
• Device Lot Number: B262360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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: 39 YR
• Patient Sex: Female