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

Model Number PED-475-30

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

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding four pipeline devices that failed to open.The patient was undergoing a flow diversion procedure to treat an unruptured saccular aneurysm of the cavernous segment of an internal carotid artery (icu).The aneurysm max diameter was 14mm and the neck diameter was 8mm.The patient's vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered with noted pru level of 160.It was reported that after 2 pipeline 5 x 25mm devices had been tried, failed to open, and removed, the physician made a third attempt to implant a flow diverter with a 4.75 x 30mm pipeline device (model: ped-475-30, lot: a619493).This device was delivered through the microcatheter and the distal end opened during deployment.However, the pipeline had a twist in the proximal end distal to the resheathing pad.The middle and proximal end of the device were positioned in a vessel bend.More than 50% of the device was deployed when it failed to open.The physician resheathed and deployed the 4.75 x 30mm pipeline a total of 3 times in different segments of the ica and attempted "wagging" to encourage the pipeline to open, but without success.The pipeline was then resheathed and removed with the microcatheter.There were no patient symptoms or complications reported related to the event.Post-procedure angiography revealed no issue.The aneurysm remained unruptured and there was no evidence of damage from the devices.

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 indicated there was resistance felt with all four pipeline devices.A continuous flush had been administered during the procedure, and no other treatment was required for the patient at the time of the report.It was noted the physician may reschedule the patient with a different manufacturer.

Manufacturer Narrative

H3: the pipeline flex braid was returned for evaluation inside of a biohazard bag and a shipping box.There was no pushwire returned with the pipeline flex braid.The distal and proximal ends of the pipeline flex braid appeared to be opened and moderately frayed.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have "resistance during delivery" and "failure to open at the proximal end" issues as the pipeline flex braid was returned without the pushwire.The root cause could not be determined as the distal and proximal ends of the pipeline flex braid were fully opened and moderately frayed.The damage to the braid on the ends of the pipeline flex is likely the results of the physician re-sheathing the device more than recommended two times.Possible causes include severe vessel tortuosity and lack of continuous flush with heparinized saline during delivery.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11047569
• MDR Text Key: 225565497
• Report Number: 2029214-2020-01352
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: A619493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR