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

Model Number PED-500-12

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

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 Description

Medtronic received report that the pipeline flex failed to open at the distal end and the tip separated within the catheter.Several unsuccessful attempts were made trying to get the distal end of the pipeline to open.Standard troubleshooting techniques were tried with a lot of catheter and distal pipeline manipulation in the vessel.Although the distal end of the pipeline would not open, the mid-section did open some.There was significant tension and resistance felt while attempting to retract and remove the un-deployed pipeline device and pushwire back into the phenom 27.Once the catheter was fully removed from the patient, the pipeline was confirmed to be stuck inside of the micro-catheter which was retrieved out by the physician and the tip was detached.The ped was stuck (locked up) in catheter.The resistance was in the proximal section of the catheter.A continuous flush was used.The catheter was kinked and flattened in the distal section.The pipeline pushwire broke at the distal end.The pipeline¿s distal section was placed in a bend in the anatomy.Less than 50% of the device was deployed when the device failed to open.The device was resheathed more than 2 times.No additional steps were made to open the device.The pipeline was resheathed and removed.Resistance was felt during the retrieval.This event occurred during the treatment of distal paraclinoid and communicating segment of the left internal carotid artery with concurrent 2.6mm blister arising from the dorsal aspect of the ica.The aneurysm was ruptured and fusiform.The max diameter was 2.6mm and the neck was +5mm.The distal landing zone was 4.2mm and the proximal was 4.3mm.The vessel anatomy was normal in tortuosity.The patient was treated with a pipeline device.The devices were prepared per the instructions for use (ifu).

Manufacturer Narrative

D10.Device available; return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation; device returned - additional information h6.Evaluation codes - additional information; device evaluation h10.Additional manufacturer narrative - additional information; device evaluation the pipeline flex was returned for analysis without the phenom-27 catheter used during the event.The distal and proximal dps restraints were found to be intact.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.A break was found on the pipeline flex delivery wire at hypotube just proximal to the proximal bumper.No stretching was found on the hypotube.The broken end of the pusher was sent out for sem and eds analysis.The braid was returned already detached and fully opened with slight fraying found on both ends.No other damages or anomalies were observed.Based on analysis of the returned device, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the braid was returned fully opened on both ends.Review of customer images, however, confirmed incomplete opening of braid.Likely causes for failure to open are the reported placement of the braid within a bend of the patient vessel and the more than 2 times reheating attempts.Other potential causes for failure include: damage braid, braid improperly sized to anatomy and braid was overstretched during delivery.Based on the analysis findings, the customer report of ¿pushwire break/separation¿ was confirmed as the returned pipeline flex pusher was found to be separated at the distal hypotube.Results of sem testing showed dimple features of the fractured area are consistent with ductile overload failure.In addition, the fractured surface exhibits corrosion damage that obscured some of the fractured features.The customer report of ¿resistance/stuck during delivery¿ could not be confirmed as the phenom catheter used during the event was not returned and the returned pipeline flex could not be used for in-house testing due to its damaged state.The fracture surface features of the broken end are consistent with tensile overload.From the damages seen on the hypotube (separating), braid (fraying) and catheter body (reported kinked/flattened distal section); it appears there was high force used.It is likely these damages occurred when the customer attempted to retrieve the pipeline flex pusher through the phenom catheter against the reported ¿significant tension and resistance¿.In this event, the user error may have contributed as the customer continued to pull the pushwire against a lot of resistance and broke the pushwire inside the microcatheter instead of retrieving the device and microcatheter simultaneously per ifu.The investigation has not been completed yet.Once the investigation has been completed, a supplemental report will be submitted.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: 9558489
• MDR Text Key: 182175701
• Report Number: 2029214-2020-00020
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: PED-500-12
• Device Lot Number: A844760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 157