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

Model Number PED-475-14

Device Problems Break (1069); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

The remainder of the pushwire has been returned; evaluation is in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex wire fracture.During the procedure, the pipeline flex device was partially deployed into the right mca and then retracted into predetermine distal zone, just proximal to the anterior choroidal artery.The pipeline was then deployed into the anterior genu without complication.There was moderate manipulation done to the proximal portion of the device in the distal landing zone to get it to open fully.Device was then fully deployed and the catheter was tracked back over the device wire for recapture.The proximal portion of the device caught and pushed 2mm distal, but the device looked good and well opposed otherwise.At some point the distal portion of the pipeline wire broke off into the catheter and was then pushed out into the artery.The treating physician then snared the distal portion, but the wire slipped off while retrieving and stents were then used to pin the wire to the vessel wall.The broken distal section was left in the right ica, proximal to the pipeline.The patient remained asymptomatic.The post procedure angiographic was clean a no deficits noted.The treating location was the right ica, ophthalmic region.The aneurysm was unruptured and saccular.The max diameter was 5.5mm and the neck was 3.5 mm.The distal landing zone was 3.8mm and the proximal was 4.75mm.The vessel anatomy was moderate in tortuosity.

Manufacturer Narrative

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 embolization device was returned as part of this investigation.Analysis found no bends or kinks were found with the pipeline flex pusher.However, the pusher was found separated at the distal hypotube proximal to the bumper.The remaining portion of the pusher was found missing and not returned.The reason for not returning the pusher was not provided.There was evidence of corrosion around the broken end.The separated hypotube end was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Per the sem/eds analysis report, elevated oxygen (o) and chloride (cl) peaks were detected on the fracture surfaces.Most of the fracture surface exhibits corrosion damage that obscured the original fracture features.Areas with dimple features consistent with ductile overload failure were observed on the fracture surface.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was confirmed.However, the root cause could not be determined.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, pushwire separa tion can occur due to certain use conditions such as excessive force and patient vessel tortuosity.The root cause, if available, is documented in the referenced investigation record.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: 9508527
• MDR Text Key: 178532096
• Report Number: 2029214-2019-01284
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016651
• UDI-Public: 00847536016651
• 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
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: PED-475-14
• Device Lot Number: A880359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 63