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

Model Number PED2-500-20

Device Problem Activation Failure (3270)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Please see mfg report 2029214-2020-01300 for additional devices associated with the event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was diagnosed with unruptured, saccular aneurysms of the right internal carotid artery, cavernous, and ophthalmic segments, and they underwent endovascular procedure on (b)(6) 2020, to treat the lesions.It happened that 3 pipeline flow redirecting stents were discarded after the devices failed to be released.The first, a 5 x 18mm pipeline (reference: ped2 - 500-18, lot: a850790), did not open distally as expected, even after attempts to recap the stent with repositioning.In an attempt to remove the device from the marksman microcatheter, it broke inside the microcatheter without us noticing and a second 5 x 20mm pipeline stent (reference: ped2-500-20, lot: a737153) was lost, as it was noticed in time that the same pushed the anterior stent into the patient's middle cerebral artery.The procedure was then interrupted with the removal of the patient's microcatheter and with no safe possibility of "saving" the 5 x 20mm pipeline, they opted for disposal.But still a third pipeline, this time a 4.75 x 20mm (reference: ped2-475-20, lot: a915540), was passed through a new marksman catheter without again being successful, since the behavior of the stent was exactly the same as of the first.The patient's treatment was only carried out safely and successfully after changing the microcatheter for a 155 cm neuroslider® 0.027 "through which a derivo® 5 x 20mm stent (acandis gmbh) was passed, in a few minutes, without any type of resistance or difficulty.The doctor indicated that the arterial route was not difficult, and they obeyed all the manufacturer's recommendations for its implantation.It was noted the dapt (dual anti-platelet treatment) was administered.There were no patient symptoms associated with the event.The devices were prepared/flushed as indicated in the ifu.

Manufacturer Narrative

B5 updated with additional information received.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 pipeline device was not place in a vessel bend when failure to open occurred.No other steps than those previously reported were attempted to open the pipeline.

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 receivedindicated that the stent was removed as a result of the issue.The procedure was completed using a competitor stent.It was also confirmed that there was no break, only that the device failed to open in the distal end.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex w/ shield (model: ped2-500-20 lot: a737153) and marksman micro catheter (model: fa-55150-1030 lot: 219359 299) found that the pipeline flex w/ shield was still within the catheter.The micro catheter was flushed with water and water exited very slowly out from the catheter tip.No resistance was found when advancing the pipeline flex w/ shield out of the micro catheter.The inner diameter was measured to be 0.027¿ which is within specification and compatible for use with the pipeline flex w/ shield.The catheter was then tested by running an in-house 0.0260¿ mandrel through microcatheter.The mandrel passed through the catheter hub, catheter body and distal tip with no resistance encountered, including the flattened section.The pipeline flex w/ shield pusher was found unbent and undamaged.When compared to the drawing, the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube was intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found intact and unstretched.Once deployed out of the micro catheter, the distal and proximal ends of the pipeline flex shield braid were found fully opened.The proximal end was found undamaged and not frayed.The distal braid was found damaged and frayed.No other a nomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal¿ could not be confirmed as the device fully opened when deployed out of the micro catheter.Possible causes for failure during procedure are patient vess el tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.Customer reported anatomy as not difficult, and device was not placed in a vessel bend.The damage to the distal tip of the marksman could have contributed towards the failure to open.Possible causes of catheter crush are patient vessel tortuosity, catheter entrapment, or user advances/retrieves intraluminal device against resistance.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d15.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
• MDR Report Key: 11004363
• MDR Text Key: 223462031
• Report Number: 2029214-2020-01301
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A737153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1