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

Model Number	PED-400-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the pipeline flex (ped) failed to expand in the middle section.Ped 4x30 was loaded and the device was pulled back below the ica bifurcation.The ped device opened up in the straight segment of the proximal top p.Com.7-8 mm of the device opened up well.The system was pulled back and physician decided to continue the deployment.At the ophthalmic bend the device did not opened.Device was re-sheathed and a second attempt to open the device was made but still the device di not opened.The device was resheathed.Another attempt was made to open the device but still it did not open.The device was taken out along with micro catheter and another ped was used.The device was less than 50% deployed when it failed to open.Less than or equal to 2 times the ped was resheathed.This event occurred during the treatment of a left ophthalmic artery, saccular aneurysm.The max diameter was 14mm and the neck was 4mm.The distal landing zone was 3.4mm and the proximal section was 4.1mm.The vessel anatomy was moderate in tortuosity.
Additional Manufacturer Narrative
D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the pipeline flex embolization device was returned for analysis.The pipeline flex pushwire was found bent at several locations from the proximal end.The pipeline flex pushwire shrink tubing was found damaged (bunching) at the proximal bumper.The pipeline flex distal hypotube was found stretched and the shrink tubing was pulled back from the proximal bumper.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The pipeline flex pushwire was found separated proximal to the ptfe sleeves.The pipeline flex ptfe sleeves, tip coil and braid were not returned and the reason for not returning was not provided.The pipeline flex pushwire was sent out for sem (scanning electron micrographic) failure analysis.No other anomalies were observed.Per the sem report, ¿the wire failed via torsional overload.¿ based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete to open at middle section (hourglass shape)¿ could not be confirmed as the pipeline flex braid was not returned.In this event, use context likely contributed to the event as the braid was reported to be deployed in vessel bend (at ophthalmic bend).In addition, as the patient vessel tortuosity was ¿moderate¿ it is possible the braid was overstretching during delivery contributing to ¿failure/incomplete open¿ issue.Based on the investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.From the damages seen with the pipeline flex pusher (hypotube stretch, shrink tube damage); it appears there was high force used.However, the root cause could not be determined.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 EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9554479
• Report Number: 2029214-2020-00010
• Device Sequence Number: 14181560
• Product Code: OUT
• UDI-Device Identifier: 00847536015999
• UDI-Public: 00847536015999
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: PED-400-30
• Device Lot Number: A884541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1